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CH 0481 Radiation Protection Regulations-Diagnostic ...
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12VAC5-481-10

Part I
General Provisions

12VAC5-481-10. Definitions.

As used in these regulations, these terms have the definitions set forth below.

"A1" means the maximum activity of special form radioactive material permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770.

"A2" means the maximum activity of radioactive material, other than special form radioactive material, LSA, and SCO material, permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

"Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer. It also means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.

"Act" means §§ 32.1-227 through 32.1-238 of the Code of Virginia.

"Active maintenance" means any significant activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in 12VAC5-481-2490 and 12VAC5-481-2500 are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

"Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

"Acute" means a single radiation dose or chemical exposure event or multiple radiation dose or chemical exposure events occurring within a short time (24 hours or less).

"Added filtration" means any filtration that is in addition to the inherent filtration.

"Address of use" means the building or buildings that are identified on the license and where radioactive material may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

"Agency" means the Radiological Health Program of the Virginia Department of Health.

"Agreement state" means any state with which the NRC or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials composed wholly or partly of licensed material exist in concentrations:

1. In excess of the derived air concentrations (DACs) specified in 12VAC5-481-3690; or

2. To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

"Air kerma (K)" or "K" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of De by Dm, where De is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass Dm. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy) kerma in air (see definition of "kerma").

"Air kerma rate" or "AKR" means the air kerma per unit time.

"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

"Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

"Analytical X-ray x-ray equipment" means equipment used for X-ray x-ray diffraction or fluorescence analysis.

"Analytical X-ray x-ray system" means a group of components utilizing x-rays or gamma-rays to determine the elemental composition or to examine the microstructure of materials.

"Annual limit on intake" (ALI) or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Tables 1 and 2 in 12VAC5-481-3690.

"Annual refresher safety training" means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions.

"Annually" means at intervals not to exceed one year.

"ANSI" means the American National Standards Institute.

"Area of use" means a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.

"Assigned protection factor (APF)" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"As low as is reasonably achievable" (ALARA) or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Articulated joint" means a joint between two separate sections of a tabletop that provides the capacity for one of the sections to pivot on the line segment along which the sections join.

"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an X-ray x-ray system or subsystem. The term includes the owner of an X-ray x-ray system or his or her employee or agent who assembles components into an X-ray x-ray system that is subsequently used to provide professional or commercial services.

"Associated equipment" means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drive, guide, or come in contact with the source.

"Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

"Authorized medical physicist" means an individual who:

1. Meets the requirements in 12VAC5-481-1760 and 12VAC5-481-1790; or

2. Is identified as an authorized medical physicist or teletherapy physicist on:

a. A specific medical use license issued by the NRC or another agreement state;

b. A medical use permit issued by an NRC master material licensee;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee; or

d. A permit issued by an NRC master material license broad scope medical use permittee.

"Authorized nuclear pharmacist" means a pharmacist who:

1. Meets the requirements in 12VAC5-481-1770 and 12VAC5-481-1790;

2. Is identified as an authorized nuclear pharmacist on:

a. A specific license issued by the NRC or another agreement state that authorizes medical use or the practice of nuclear pharmacy;

b. A permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy;

3. Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

4. Is designated as an authorized nuclear pharmacist in accordance with 12VAC5-481-440 I 2.

"Authorized user" means a practitioner of the healing arts who:

1. Meets the requirements in 12VAC5-481-1790 and any of the following:

a. 12VAC5-481-1910;

b. 12VAC5-481-1940;

c. 12VAC5-481-1980;

d. 12VAC5-481-1990;

e. 12VAC5-481-2000;

f. 12VAC5-481-2010;

g. 12VAC5-481-2030;

h. 12VAC5-481-2040; or

2. Is identified as an authorized user on:

a. A specific license issued by the NRC or another agreement state that authorizes medical use;

b. A permit issued by an NRC master material licensee that authorizes medical use;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee that authorizes medical use; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use.

"Automatic exposure control (AEC)" or "AEC" means a device that automatically controls one or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation (includes devices such as phototimers and ion chambers).

"Background radiation" means radiation from cosmic sources, naturally occurring radioactive materials, that have not been technologically enhanced, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the agency.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the X-ray x-ray fields.

"Beam-limiting device" means a device that provides a means to restrict the dimensions of the X-ray x-ray field.

"Beam monitoring system" means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.

"Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

"Becquerel" (Bq) or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps).

"Beneficial attribute" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the radioactivity of the product necessary to the use of the product.

"Beneficial to the product" see "Beneficial attribute."

"Bent beam linear accelerator" means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in-vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.

"Board" means the State Board of Health.

"Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

"Buffer zone" means a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site.

"Byproduct material" means:

1. Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

2. The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

3. a. Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

b. Any material that:

(1) Has been made radioactive by use of a particle accelerator; and

(2) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

4. Any discrete source of naturally occurring radioactive material, other than source material, that:

a. The NRC, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

b. Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"C-arm X-ray system fluoroscope" means an X-ray x-ray system in which the image receptor and X-ray x-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.

"Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for individual members of the public as specified in 12VAC5-481-720.

"Cabinet X-ray x-ray system" means an X-ray x-ray system with the X-ray x-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. The cabinet X-ray x-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included are all X-ray x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An X-ray x-ray tube used within a shielded part of a building, or X-ray x-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet X-ray x-ray system.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (i) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument or (ii) the strength of a source of radiation relative to a standard.

"Camera" (See "Radiographic exposure device").

"Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

"Cassette holder" means a device, other than a spot-film device, that supports or fixes the position of an x-ray film (imaging) cassette during an x-ray exposure.

"Cephalometric device" means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

"Certifiable cabinet X-ray x-ray system" means an existing uncertified X-ray x-ray system that has been modified to meet the certification requirements specified in 21 CFR 1020.40.

"Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the NRC.

"Certificate of compliance (CoC)" or "COC" means the certificate issued by the NRC that approves the design of a package for the transportation of radioactive material.

"Certified cabinet X-ray x-ray system" means an X-ray x-ray system that has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40.

"Certified components" means components of X-ray x-ray systems that are subject to regulations promulgated under Pub.L. 90-602, the Radiation Control for Health and Safety Act of 1968 of the Food and Drug Administration.

"Certified system" means any X-ray system which has one or more certified component(s).

"Certifying entity" means an independent certifying organization meeting the agency's requirements for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent state or NRC regulations.

"CFR" means Code of Federal Regulations.

"Changeable filters" means any filter, exclusive of inherent filtration, that can be removed from the useful beam through any electronic, mechanical, or physical process.

"Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.

"Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.

"Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, Days, of less than 10 days; for Class W, Weeks, from 10 to 100 days; and for Class Y, Years, of greater than 100 days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms.

"Closed transport vehicle" means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be either temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.

"cm" means centimeters.

"Coefficient of variation (C)" or "C" means the ratio of the standard deviation to the mean value of a set population of observations. It is estimated using the following equation:

http://leg5.state.va.us/images/694023673486LEGJDC_files/image001.gif

where:

s = Standard deviation of the observed values;

X̅ = Mean value of observations in sample;

xi = ith observation in sample;

n = Number of observations in sample.

"Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

"Collimator" means a device used to limit the size, shape, and direction of the primary radiation beam. For industrial radiography it means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

"Commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a land disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values.

"Committed dose equivalent" (HT,50) or "HT,50" means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

"Committed effective dose equivalent" (HE, 50) or "HE, 50" is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ (wT HT,50)).

"Computed tomography" means the production of a tomogram by the acquisition and computer processing of X-ray x-ray transmission data.

"Computed tomography dose index" means the integral from -7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

eCFR graphic ec01ap93.003.gif

where:

z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness;

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

"Computer-readable medium" means that the regulatory agency's computer can transfer the information from the medium into its memory.

"Consignee" means the designated receiver of the shipment of low-level radioactive waste.

"Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a federal facility or a medical facility.

"Constraint" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Constraint (dose constraint)" or "dose constraint" means a value above which specified licensee actions are required.

"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five centimeters.

"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:

http://leg5.state.va.us/images/406037704549LEGLDH_files/image001.gif

where:

μ= Linear attenuation coefficient of the material of interest;

μ= Linear attenuation coefficient of water;

http://leg5.state.va.us/images/406037803941LEGLDH_files/image002.gif = of the material of interest;

http://leg5.state.va.us/images/406037933694LEGLDH_files/image001.gif = of water.

"Control (drive) cable" or "drive" means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

"Control drive mechanism" means a device that enables the source assembly to be moved into and out of the exposure device.

"Control panel" means that part of the X-ray x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.

"Control tube" means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

"Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.

"Conveyance" means:

1. For transport by public highway or rail any transport vehicle or large freight container;

2. For transport by water any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

3. For transport by any aircraft.

"Cooling curve" means the graphical relationship between heat units stored and cooling time.

"Cradle" means either:

1. A removable device that supports and may restrain a patient above an x-ray table; or

2. A device:

a. Whose patient support structure is interposed between the patient and the image receptor during normal use;

b. Which is equipped with means for patient restraint; and

c. Which is capable of rotation about its long (longitudinal) axis.

"Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"Criticality safety index (CSI)" or "CSI" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages containing fissile material during transportation. Determination of the criticality safety index is described in Part XIII (12VAC5-481-2950 et seq.).

"CS" (See "Contrast scale").

"CT" (See "Computed tomography").

"CT conditions of operation" means all selectable parameters governing the operation of a CT X-ray x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in these regulations.

"CTDI" (See "Computed tomography dose index").

"CT gantry" means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.

"CTN" (See "CT number").

"CT Number" number" means the number used to represent the X-ray x-ray attenuation associated with each elemental area of the CT image.

http://leg5.state.va.us/images/406037933678LEGLDH_files/image001.gif

where:

http://leg5.state.va.us/images/406037933678LEGLDH_files/image002.gif = A constant, a normal value of 1,000 when the Houndsfield scale of CTN is used;

http://leg5.state.va.us/images/406038106775LEGLDH_files/image001.gif = Linear attenuation coefficient of the material of interest;

http://leg5.state.va.us/images/406038106775LEGLDH_files/image002.gif = Linear attenuation coefficient of water.

"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contribution from fluoroscopic and radiographic irradiation.

"Curie" means a unit of quantity of activity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

"Custodial agency" means an agency of the government designated to act on behalf of the government owner of the disposal site.

"Dead-man switch" means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

"Declared pregnant woman" means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

"Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license or release of the property under restricted conditions and termination of the license.

"Decontamination facility" means a facility operating under a Commission or Agreement State license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this part, is not considered to be a consignee for LLW shipments.

"Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.

"Deep dose equivalent" (Hd), or "Hd," which applies to external whole body exposure, means the dose equivalent at a tissue depth of one centimeter (1000 mg/cm²).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

"Department of Energy" means the Department of Energy established by Pub. L. 95-91, August 4, 1977, 91 Stat. 565, 42 USC § 7101 et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers, and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 USC § 5814, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 USC § 7151, effective October 1, 1977.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percentage of the total uranium present. Depleted uranium does not include special nuclear material.

"Derived air concentration" (DAC) or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these regulations, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in 12VAC5-481-3690.

"Derived air concentration-hour" (DAC-hour) or "DAC hour" means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

"Detector" (See "Radiation detector").

"Deuterium" means, for the purposes of Part XIII (12VAC5-481-2950 et seq.) deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.

"Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures, where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic X-ray x-ray system" means an X-ray x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

"Diagnostic X-ray imaging system" means an assemblage of components for the generation, emission and reception of X-rays and the transformation, storage and visual display of the resultant X-ray image.

"Direct scattered radiation" means that scattered radiation that has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Disposal" means the isolation of wastes from the biosphere inhabited by man and his food chains by emplacement in a land disposal facility.

"Disposal container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that for some shipments, the disposal container may be the transport package.

"Disposal site" means that portion of a land disposal facility that is used for disposal of waste. It consists of disposal units and a buffer zone.

"Disposal unit" means a discrete portion of the disposal site into which waste is placed for disposal. For near-surface disposal, the unit is usually a trench.

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

"Dose equivalent (HT)" or "HT" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

"Dose monitor unit (DMU)" or "DMU" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

"Dose profile" means the dose as a function of position along a line.

"Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

"Doubly encapsulated sealed source" means a sealed source in which the radioactive material is sealed within an inner capsule and that capsule is sealed within an outer capsule.

"Drive cable" (See "Control cable").

"Effective dose equivalent (HE)" or "HE" means the sum of the products of the dose equivalent (HT) to each organ or tissue and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

"Elemental area" means the smallest area within a tomogram for which the X-ray x-ray attenuation properties of a body are depicted. (See also "Picture element").

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Energy compensation source (ECS)" or "ECS" means a small sealed source, with an activity not exceeding 3.7 MBq (100 μCi), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

"Engineered barrier" means a manmade structure or device that is intended to improve the land disposal facility's ability to meet the performance objectives in these regulations.

"Enriched uranium" (See "Uranium – natural, depleted, enriched").

"Entrance exposure rate" means the exposure free in air per unit time at the point where the center of the useful beam enters the patient.

"Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

"EPA identification number" means the number received by a transporter following application to the Administrator of EPA as required by 40 CFR Part 263.

"Equipment" (See "X-ray equipment").

"Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

"Explosive material" means any chemical compound, mixture, or device that produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

"Exposure" means being exposed to ionizing radiation or to radioactive material.

"Exposure head" means a device that locates the gamma radiography sealed source in the selected working position.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

"External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

"Facility" means the location, building, vehicle, or complex under one administrative control, at which one or more radiation machines are installed, located and/or used.

"Fail-safe characteristics" mean a design feature that causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.

"Field emission equipment" means equipment that uses an X-ray x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.

"Field station" means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary jobsites.

"Filter" means material placed in the useful beam to preferentially absorb selected radiations. It also means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to Part XV (12VAC5-481-3380 et seq.) of this chapter.

"Filtering facepiece (dusk mask)" or "dusk mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. "Fissile material" means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium, that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in 10 CFR 71.15.

1. Fissile Class I: A package that may be transported in unlimited numbers and in any arrangement, and that requires no nuclear criticality safety controls during transportation. A transport index is not assigned for purposes of nuclear criticality safety but may be required because of external radiation levels.

2. Fissile Class II: A package that may be transported together with other packages in any arrangement but, for criticality control, in numbers that do not exceed an aggregate transport index of 50. These shipments require no other nuclear criticality safety control during transportation. Individual packages may have a transport index not less than 0.1 and not more than 10.

"Fissile material package" means a fissile material packaging together with its fissile material contents.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

"Fluoroscopic imaging assembly" means a subsystem in which X-ray x-ray photons produce a visible image set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s) such as the image intensifier and spot-film device receptors, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.

"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.

"Focal spot (actual)" or "actual" means the area projected on the anode of the X-ray x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

"Former Atomic Energy Commission or NRC licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or NRC licenses have been terminated.

"Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"General environment" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the total terrestrial, atmospheric, and aquatic environments outside the site boundary within which any activity, operation, or process authorized by a general or specific license issued under Part XVI, is performed.

"General purpose radiographic X-ray x-ray system" means any radiographic X-ray x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

"Generator" means a licensee who (i) is a waste generator as defined in this chapter, or (ii) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g., waste generated as a result of decontamination or recycle activities).

"Gonad shield" means a protective barrier for the testes or ovaries.

"Gray (Gy)" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (100 rad).

"Guide tube (protection sheath)" means a flexible or rigid tube, or "J" tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

"Half-value layer (HVL)" or "HVL" means the thickness of a specified material that attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-half of the value measured without the material at the same point the beam of radiation to an extent that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

"Hand-held radiographic unit" means x-ray equipment that is designed to be hand-held during operation.

"Hands-on experience" means experience in all of those areas considered to be directly involved in the radiography process, and includes taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records and radiation area surveillance, etc., as applicable. Excessive time spent in only one or two of these areas, such as film development or radiation area surveillance, should not be counted toward the 2,000 hours of hands-on experience required for a radiation safety officer in 12VAC5-481-1310 A 2 or the hands-on experience for a radiographer as required by 12VAC5-481-1320 A.

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261.

"Healing arts" means the art or science or group of arts or sciences dealing with the prevention and cure or alleviation of ailments, diseases or infirmities, and has the same meaning as "medicine" when the latter term is used in its comprehensive sense.

"Healing arts screening" means the testing of human beings using X-ray x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray x-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, such as (kVp) times (mA) times (seconds).

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High integrity container (HIC)" or "HIC" means a container commonly designed to meet the structural stability requirements of 12VAC5-481-2572 and to meet U.S. Department of Transportation requirements for a Type A package.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one mSv (0.1 rem) in one hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"HVL" (See "Half-value layer").

"Hydrogeologic unit" means any soil or rock unit or zone which by virtue of its porosity or permeability, or lack thereof, has a distinct influence on the storage or movement of groundwater.

"Image intensifier" means a device, installed in its housing, that instantaneously converts an X-ray x-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen or, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector that transforms incident X-ray x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device.

"Image receptor support device" means, for mammographic systems, that part of the system designed to support the image receptor during mammography mammographic examination and to provide a primary protective barrier.

"Inadvertent intruder" means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling construction, or other pursuits in which an individual might be unknowingly exposed to radiation from the waste.

"Independent certifying organization" means an independent organization that meets the agency's criteria for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent agreement state or NRC regulations.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

1. Dose equivalent (i) by the use of individual monitoring devices or (ii) by the use of survey data; or

2. Committed effective dose equivalent (i) by bioassay or (ii) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition of DAC)

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal air sampling devices.

"Industrial radiography" means an examination of the structure of materials by the nondestructive method of utilizing ionizing radiation to make radiographic images.

"Inhalation class" (See "Class").

"Inherent filtration" means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.

"Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the agency.

"Institutional controls" means: (i) permanent markers placed at a disposal site, (ii) public records and archives, (iii) government ownership and regulations regarding land or resource use, and (iv) other methods of preserving knowledge about the location, design, and contents of a disposal system.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program that requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology or other equivalent national or international program.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

"Intruder barrier" means a sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in these regulations, or engineered structures that provide equivalent protection to the inadvertent intruder.

"Irradiation" means the exposure of matter to ionizing radiation.

"Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (500 rads) per hour exist at one meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

"Irradiator operator" means an individual who has successfully completed the training and testing described in 12VAC5-481-2830 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

"Irradiator operator supervisor" means an individual who meets the requirements for an irradiator operator and who physically oversees operation of the irradiator by an individual who is currently receiving training and testing described in 12VAC5-481-2830.

"Isocenter" means the center of the smallest sphere through which the useful beam axis passes while the gantry moves through its full range of motions when the equipment moves through a full range of rotations about its common center.

"kBq" means kilabecquerels.

"Kerma" or "K" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all charged particles liberated by uncharged particles in a mass dm of materials; thus K=dEtr/dm, in units of J/kg, where the special name for the units of kerma is gray (Gy). When the materials is air, the quantity is referred to as "air kerma."

"Kilovolt (kV) (kilo electron volt (keV))" or "kV" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of 1,000 volts in a vacuum. Current convention is to use kV for photons and keV for electrons.

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Land disposal facility" means the land, buildings, structures and equipment that is intended to be used for the disposal of wastes into the subsurface of the land. For purposes of this chapter, a "geologic repository" as defined in 10 CFR Part 60 or 10 CFR Part 63 is not considered a land disposal facility.

"Last image hold radiograph" or "LIH" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

"Lay-barge radiography" means industrial radiography performed on any water vessel used for laying pipe.

"Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.

"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:

1. The useful beam; and

2. Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly that are used in measuring leakage radiation. They are defined as follows:

1. For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere seconds (10 mAs), or the minimum obtainable from the unit, whichever is larger;

2. For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of X-ray x-ray pulses in an hour for operation at the maximum-rated peak tube potential; or

3. For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Lens dose equivalent (LDE)" or "LDE" applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 cm (300 mg/cm2).

"License" means a license issued by the agency in accordance with the regulations adopted by the board.

"Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the agency.

"Licensee" means any person who is licensed by the agency in accordance with these regulations and the Act.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

"Limits" (See "Dose limits").

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percentage percent of the load line potential. It is calculated using the following equation as follows:

Percent line-voltage regulation = 100 (Vn-Vl)/Vl

where:

Vn = No-load line potential; and

Vl = Load line potential.

"Lixiscope" means a portable light-intensified imaging device using a sealed source.

"Local components" mean part of an analytical X-ray x-ray system and include areas that are struck by X-rays x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.

"Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by Part XIV (12VAC5-481-3140 et seq.) of this chapter.

"Logging supervisor" means the individual who uses licensed material or provides personal supervision in the use of licensed material at a temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of this chapter and the conditions of the license.

"Logging tool" means a device used subsurface to perform well-logging.

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing licensed material" means licensed (or registered) source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Lot tolerance percent defective" means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

"Low specific activity (LSA) material" or "LSA" means radioactive material with limited specific activity that is nonfissile or is excepted under 12VAC5-481-2970 C, and that satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups:

1. LSA-I

a. Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclide that are not intended to be processed for the use of these radionuclides;

b. Solid unirradiated natural uranium or depleted uranium or natural thorium or their solid or liquid compounds or mixtures;

c. Radioactive material, for which the A2 value is unlimited; or

d. Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined in accordance with 12VAC5-481-3720.

2. LSA-II

a. Water with tritium concentration up to 0.8 terabecquerel per liter (20.0 Ci/L); or

b. Other material in which the activity is distributed throughout, and the average specific activity does not exceed 1.0 E-04 A2/g for solids and gases, and 1.0 E-05 A2/g for liquids.

3. LSA-III

Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 CFR 71.77) in which:

a. The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (for example: concrete, bitumen, or ceramic);

b. The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed 0.1 A2; and

c. The estimated average specific activity of the solid does not exceed 2.0 E-03 A2/g.

"Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days.

"Lung class" (See "Class").

"mA" means milliampere.

"mAs" means milliampere second.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in this section.

"Maximum line current" means the root-mean-square current in the supply line of an X-ray machine operating at its maximum rating.

"Management" means the chief executive officer or that individual's designee.

"MBq" means megabecquerels.

"Medical event" means an event that meets the criteria in 12VAC5-481-2080.

"Medical institution" means an organization in which several medical disciplines are practiced.

"Medical use" means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

"Megavolt (MV) (mega electron volt (MeV))" or "MV" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. (Note: current convention is to use MV for photons and MeV for electrons.)

"Member of the public" means an individual except when that individual is receiving an occupational dose.

"Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

"Minor" means an individual less than 18 years of age.

"Misadministration" means either:

1. An x-ray teletherapy radiation dose:

a. Involving the wrong patient;

b. Involving the wrong mode of treatment;

c. Involving the wrong treatment site;

d. Where the calculated total administered dose differs from the total prescribed dose by more than 10% when the treatment consists of three or fewer fractions;

e. Where the calculated weekly administered dose differs from the weekly prescribed dose by 30%; or

f. Where the calculated total administered dose differs from the total prescribed dose by more than 20%; or

2. An x-ray brachytherapy radiation dose:

a. Involving the wrong patient;

b, Involving the wrong treatment site; or

c. Where the calculated administered dose differs from the prescribed dose by more than 20%.

"mm" means millimeters.

"Mobile nuclear medicine service" means the transportation and medical use of radioactive material.

"Mobile X-ray x-ray equipment" (See "X-ray equipment").

"Mode of operation" means, for fluoroscopy systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.

"Monitor unit (MU)" or "MU" (See "Dose monitor unit").

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. For Part XI (12VAC5-481-2330 et seq.) of this chapter, it means observing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

"Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

"Multiple tomogram system" means a computed tomography X-ray x-ray system that obtains X-ray x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

"NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.

"National Sealed Source and Device Registry" or "SSDR" means the national registry that contains the registration certificates, maintained by the NRC, that summarize the radiation safety information for sealed sources and devices, and describes the licensing and use conditions approved for the product.

"Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in 12VAC5-481-3780. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and that is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes, which is essentially 100 weight percent thorium-232.

"Natural uranium" (See "Uranium – natural, depleted, enriched").

"Near-surface disposal facility" means a land disposal facility in which waste is disposed of within approximately the upper 30 meters of the earth's surface.

"Negative pressure respirator (tight fitting)" or "tight fitting" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:

http://leg5.state.va.us/images/406038286294LEGLDH_files/image001.gif

where:

http://leg5.state.va.us/images/406038286294LEGLDH_files/image002.gif = Linear attenuation coefficient of the material of interest.

http://leg5.state.va.us/images/406038461267LEGLDH_files/image001.gif = Linear attenuation coefficient of water.

http://leg5.state.va.us/images/406038461267LEGLDH_files/image002.gif = Standard deviation of the CTN of picture elements in a specified area of the CT image.

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray x-ray transmission data are collected.

"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.

"Nonstochastic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these regulations, "deterministic effect" is an equivalent term.

"NORM" means any naturally occurring radioactive material. It does not include accelerator produced, byproduct, source, or special nuclear material.

"Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

"Normal operating procedures" mean step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant (or licensee), and data recording procedures, which are related to radiation safety.

"Nominal treatment distance" means:

1. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

2. For X-ray x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For nonisocentric equipment, this distance shall be that specified by the manufacturer.

"NRC Forms 540, 540A, 541, 541A, 542, and 542 542A" means official NRC forms referenced in this chapter. Licensees need not use originals of these NRC Forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.

"Nuclear Regulatory Commission (NRC)" or "NRC" means the NRC or its duly authorized representatives.

"Nuclear waste" means a quantity of source, byproduct or special nuclear material (the definition of nuclear waste in this part is used in the same way as in 49 CFR 173.403) required to be in NRC-approved specification packaging while transported to, through or across a state boundary to a disposal site, or to a collection point for transport to a disposal site.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, from voluntary participation in medical research programs, or as a member of the public.

"Offshore platform radiography" means industrial radiography conducted from a platform over a body of water.

"Offshore waters" means that area of land and water, beyond the Commonwealth of Virginia's jurisdiction, on or above the U.S. Outer Continental Shelf.

"Open-beam configuration" means an analytical X-ray x-ray system in which an individual could accidentally place some part of his body in the primary beam path during normal operation.

"Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

"Package" means the packaging together with its radioactive contents as presented for transport.

1. Fissile material package or Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package means a fissile material packaging together with its fissile material contents.

2. Type A package means a Type A packaging together with its radioactive contents. A Type A package is defined and must comply with the DOT regulations in 49 CFR Part 173.

3. Type B package means a Type B packaging together with its radioactive contents. On approval, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lbs/in2) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 CFR 71.73 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR Part 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.19.

"Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of these regulations. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

"Panoramic dry-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

"Panoramic irradiator" means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

"Panoramic wet-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

"Particle accelerator" (See "Accelerator").

"Patient" means an individual or animal subjected to healing arts examination, diagnosis, or treatment.

"PBL" (See "Positive beam limitation").

"Peak tube potential" means the maximum value of the potential difference across the X-ray x-ray tube during an exposure.

"Periodic quality assurance check" means a procedure that is performed to ensure that a previous calibration continues to be valid.

"Permanent radiographic installation" means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, department of the Commonwealth other than the Department of Health, political subdivision of the Commonwealth, any other state or political subdivision or department thereof, and any legal successor, representative, agent, or department of the foregoing, but not including federal government agencies.

"Personal supervision" means guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required. In radiography it means guidance and instruction provided to a radiographer trainee by a radiographer instructor who is present at the site, in visual contact with the trainee while the trainee is using sources of radiation, and in such proximity that immediate assistance can be given if required.

"Personnel monitoring equipment" (See "Individual monitoring devices").

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"Physical description" means the items called for on NRC Form 541 to describe a low-level radioactive waste.

"Pool irradiator" means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.

"Pharmacist" means an individual licensed by this state to compound and dispense drugs, prescriptions, and poisons.

"Physician" means an individual licensed by this state to prescribe drugs in the practice of medicine.

"Picture element" means an elemental area of a tomogram.

"PID" (See "Position indicating device").

"Pigtail" (See "Source assembly").

"Pill" (See "Sealed source").

"Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

"Portable X-ray x-ray equipment" (See "X-ray equipment").

"Position indicating device" means a device on dental X-ray x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an X-ray x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Positive emission tomography (PET) radionuclide production facility" or "PET" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Practical examination" means a demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.

"Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung X-rays x-rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" (Medical Physics 18(1): 73-109, Jan/Feb. 1991) and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV", International Commission on Radiation Units and Measurements, September 15, 1984.

"Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.

"Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:

1. In a written directive; or

2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

"Prescribed dose" means:

1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive; or

2. For teletherapy, the total dose and dose per fraction as documented in the written directive; or

3. For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

"Primary beam" means radiation that passes through an aperture of the source housing by a direct path from the X-ray x-ray tube or a radioactive source located in the radiation source housing.

"Primary dose monitoring system" means a system that will monitor the useful beam during irradiation and that will terminate irradiation when a preselected number of dose monitor units have been delivered.

"Primary protective barrier" (See "Protective barrier") means the material, excluding filters, placed in the useful beam to reduce the radiation exposure (beyond the patient and cassette holder) for protection barriers.

"Principal activities," as used in this chapter, means activities authorized by the license that are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

"Private inspector" means an individual who meets the requirements set forth in 12VAC5-481-340 and who has demonstrated to the satisfaction of the agency that such individual possesses the knowledge, training and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs.

"Product" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, something produced, made, manufactured, refined, or benefited.

"Product conveyor system" means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

"Projection sheath" (See "Guide tube").

"Projector" (See "Radiographic exposure device").

"Protective apron" means an apron made of radiation-attenuating or absorbing materials used to reduce exposure to radiation.

"Protective barrier" means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

1. "Primary protective barrier" means the material, excluding filters, placed in the useful beam;

2. "Secondary protective barrier" means the material that attenuates stray radiation.

"Protective glove" means a glove made of radiation absorbing materials used to reduce radiation exposure.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, or from voluntary participation in medical research programs.

"Pulsed mode" means operation of the x-ray system such that the x-ray tube is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.

"Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 130°F (54.4°C) or any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or that can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

"Qualitative fit test (QLFT)" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

"Quality factor" (Q) or "Q" means the modifying factor, that is referenced in 12VAC5-481-240, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Quarter" means a period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

"Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, X-rays x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include nonionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" (See "Dose").

"Radiation field" (See "Useful beam").

"Radiation head" means the structure from which the useful beam emerges.

"Radiation machine" means any device capable of producing radiation except those devices with radioactive material as the only source of radiation.

"Radiation room" means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

"Radiation safety officer (RSO)" or "RSO" means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee or registrant.

"Radiation safety officer for industrial radiography" means an individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of 12VAC5-481-1310.

"Radiation safety officer for medical" means an individual who meets the requirements of 12VAC5-481-1750 and 12VAC5-481-1790 or is identified as an RSO on: a medical use license issued by the agency, NRC or another agreement state, or a medical use permit issued by an NRC masters material licensee.

"Radiation therapy physicist" means an individual qualified in accordance with 12VAC5-481-340.

"Radiation therapy simulation system" means a radiographic or fluoroscopic X-ray x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radioactive material" means any solid, liquid, or gas which emits radiation spontaneously.

"Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" (See "Bioassay").

"Radiograph" means an image receptor on which the image is created directly or indirectly by an X-ray x-ray pattern and results in a permanent record.

"Radiographer" means any individual who performs or who, in attendance at the site where the sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of the agency's regulations and the conditions of the license or registration.

"Radiographer certification" means written approval received from a certifying entity stating that an individual has satisfactorily met the radiation safety, testing, and experience criteria in 12VAC5-481-1320.

"Radiographer instructor" means any radiographer who has been authorized by the agency to provide on-the-job training to radiographer trainees in accordance with Part V (12VAC5-481-1170 et seq.) of this chapter.

"Radiographer trainee" means any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of his instruction.

"Radiographer's assistant" means any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sources of radiation, related handling tools, or radiation survey instruments in industrial radiography.

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

"Radiographic imaging system" means any system whereby a permanent or semi-permanent image is recorded on an image receptor by the action of ionizing radiation.

"Radiographic operations" means all activities performed with a radiographic exposure device, or with a radiation machine. Activities include using, transporting except by common or contract carriers, or storing at a temporary job site, performing surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. Transporting a radiation machine is not considered a radiographic operation.

"Radiographic personnel" means any radiographer, radiographer instructor, or radiographer trainee.

"Radiography" (See "Industrial radiography") means:

1. For radioactive materials: See "Industrial radiography."

2. For x-ray: A technique for generating and recording an x-ray pattern for the purpose of providing the user with an image after termination of the exposure.

"Rating" means the operating limits as specified by the component manufacturer.

"Reasonably maximally exposed individual" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, a representative of a population who is exposed to TENORM at the maximum TENORM concentration measured in environmental media found at a site along with reasonable maximum case exposure assumptions. The exposure is determined by using maximum values for one or more of the most sensitive parameters affecting exposure, based on cautious but reasonable assumptions, while leaving the others at their mean value.

"Recording" means producing a permanent retrievable form of an image resulting from X-ray x-ray photons.

"Redundant beam monitoring system" means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a preselected number of dose monitor units.

"Reference man" means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of the reference man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man."

"Reference plane" means a plane that is displaced from and parallel to the tomographic plane.

"Registrant" means any person who is registered with the agency and is legally obligated to register with the agency pursuant to these regulations and the Act.

"Registration" means registration with the agency in accordance with the regulations adopted by the agency.

"Regulations of the United States Department of Transportation" means the regulations in 49 CFR Parts 100-189.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

"Reportable event" means the administration of either:

1. A diagnostic x-ray exposure where an actual or suspected acute or long-term functional damage to an organ or a physiological system has occurred. Exempt from this reporting requirement is any event when any functional damage to a patient organ or a physiological system that was an expected outcome when the causative procedures were prescribed;

2. A procedure where the patient or operator is injured as a result of a mechanical injury;

3. A teletherapy x-ray dose where the calculated weekly administered dose differs from the weekly prescribed dose by 15% or more; or

4. A brachytherapy x-ray dose where the calculated administered dose differs from the prescribed dose by 10% or more.

"Research and development" means (i) theoretical analysis, exploration, or experimentation; or (ii) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstrative purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

"Residential location" means any area where structures in which people lodge or live are located, and the grounds on which such structures are located including, but not limited to, houses, apartments, condominiums, and garages.

"Residual radioactive material" means (i) waste (that the U.S. Secretary of Energy determines to be radioactive) in the form of tailings resulting from the processing of ores for the extraction of uranium and other valuable constituents of the ores and (ii) other waste (that the U.S. Secretary of Energy determines to be radioactive) at a processing site that relates to such processing, including any residual stock of unprocessed ores or low-grade materials. This term is used only with respect to materials at sites subject to remediation under Title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part IV (12VAC5-481-600 et seq.) of this chapter.

"Residual waste" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.

"Respiratory protective device" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and 12VAC5-481-240).

"S-tube" means a tube through which the radioactive source travels when inside a radiographic exposure device.

"Sanitary sewerage" means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.

"Scan" means the complete process of collecting X-ray x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT X-ray x-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a preselected set of two or more scans performed consecutively under preselected CT conditions of operation.

"Scan time" means the period of time between the beginning and end of X-ray x-ray transmission data accumulation for a single scan.

"Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

"Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the NRC, that summarize the radiation safety information for sealed sources and devices, and describes the licensing and use conditions approved for the product.

"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

"Secondary protective barrier" (See "Protective barrier").

"Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the United States Geological Survey.

"Self-contained breathing apparatus (SCBA)" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.

"Shallow dose equivalent (Hs)," or "Hs" which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

"Shielded position" means the location within the radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.

"Shielded-room radiography" means industrial radiography conducted in a room shielded so that radiation levels at every location on the exterior meet the limitations specified in 12VAC5-481-640.

"Shipper" means the licensed entity (i.e., the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.

"Shipping paper" means NRC Form 540 and, if required, NRC Form 540A, which includes the information required by DOT the U.S. Department of Transportation in 49 CFR Part 172.

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SI" means the abbreviation for the International System of Units.

"SID" (See "Source-image receptor distance").

"Sievert" (Sv) or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

"Simulator (radiation therapy simulation system)" or "radiation therapy simulation system" means any X-ray x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.

"Single tomogram system" means a CT X-ray x-ray system that obtains X-ray x-ray transmission data during a scan to produce a single tomogram.

"Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

"Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.

"Site closure and stabilization" means those actions that are taken upon completion of operations that prepare the disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

"Source" means the focal spot of the X-ray x-ray tube.

"Source assembly" means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may include a ballstop to secure the source in the shielded position.

"Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources.

"Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source material" means:

1. Uranium or thorium, or any combination thereof, in any physical or chemical form; or

2. Ores that contain by weight one-twentieth of 1.0% (0.05%) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source-skin distance (SSD)" or "SSD" means the distance between from the source and the skin entrance plane of the patient to the center of the entrant x-ray field in the plane tangent to the patient's skin surface.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory that participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

1. It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

2. The piece or capsule has at least one dimension not less than five millimeters (0.2 in.); and

3. It satisfies the test requirements specified by the NRC. A special form encapsulation designed in accordance with the NRC requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after April 1, 1998, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material the NRC, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

2. Any material artificially enriched by any of the foregoing but does not include source material.

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

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"Specific activity" of a radionuclide means the radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

"Spot film" means a radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure.

"Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the X-ray x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

"Stability" means structural stability.

"State inspector" means an employee of the Virginia Department of Health designated to perform those duties or functions assigned the Radiological Health Program.

"Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

"Stationary X-ray x-ray equipment" (See "X-ray equipment").

"Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these regulations, "probabilistic effect" is an equivalent term.

"Storage" means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable.

"Storage area" means any location, facility, or vehicle that is used to store and secure a radiographic exposure device, a radiation machine, or a storage container when it is not used for radiographic operations. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the device, machine, or container.

"Storage container" means a device in which sealed sources or radiation machines are secured and stored.

"Stray radiation" means the sum of leakage and scattered radiation.

"Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

"Supplied-air respirator (SAR) or," "airline respirator" or "SAR" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Surface contaminated object" (SCO) or "SCO" means a solid object that is not itself classed as radioactive material, but that has radioactive material distributed on any of its surfaces. An SCO must be in one of two groups with surface activity not exceeding the following limits:

1. SCO-I: A solid object on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed four becquerel per cm² (1 E-04 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerel per cm² (1 E-05 μCi/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4 E+04 becquerel per cm² (1.0 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 becquerel per cm² (0.1 μCi/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4 E+04 becquerel per cm² (1 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 Becquerel per cm² (0.1 μCi/cm²) for all other alpha emitters.

2. SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 400 becquerel per cm² (1 E-02 μCi/cm²) for beta and gamma and low toxicity alpha emitters or 40 becquerel per cm² (1 E-03 μCi/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8 E+05 becquerel per cm² (20 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 becquerel per cm² (2 μCi/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8 E+05 becquerel per cm² (20 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 becquerel per cm² (2 μCi/cm²) for all other alpha emitters.

"Surveillance" means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

"Tabletop, stationary" means a tabletop that, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.

"Target" means that part of an X-ray x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

"Technologically Enhanced Naturally Occurring Radioactive Material (TENORM)" or "TENORM" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, naturally occurring radionuclides whose concentrations are increased by or as a result of past or present human practices. TENORM does not include background radiation or the natural radioactivity of rocks or soils. TENORM does not include uranium or thorium in "source material" as defined in the AEA and NRC regulations.

"Technique factors" means the following conditions of operation:

1. For capacitor energy storage equipment, peak tube potential in kV kilovolts (kV) and quantity of charge in mAs milliampere-seconds (mAs);

2. For field emission equipment rated for pulsed operation, peak tube potential in kV kilovolts (kV), and number of X-ray x-ray pulses;

3. For CT X-ray systems equipment designed for pulsed operation, peak tube potential in kV kilovolts (kV), scan time in seconds, and either tube current in Ma milliamperes (mA), X-ray x-ray pulse width in seconds, and the number of X-ray x-ray pulses per scan, or the product of tube current, X-ray x-ray pulse width, and the number of X-ray x-ray pulses in mAs milliampere-seconds (mAs);

4. For CT X-ray systems equipment not designed for pulsed operation, peak tube potential in kV kilovolts (kV), and either tube current in Ma milliamperes (mA) and scan time in seconds, or the product of tube current and exposure time in mAs milliampere-seconds (mAs) and the scan time when the scan time and exposure time are equivalent; and

5. For all other equipment, peak tube potential in kV kilovolts (kV), and either tube current in Ma milliamperes (mA) and exposure time in seconds, or the product of tube current and exposure time in mAs milliampere-seconds (mAs).

"Teletherapy physicist" means an individual identified as a qualified teletherapy physicist on an agency license.

"Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"Temporary job site" means any location where industrial radiography, wireline service, well-logging, portable gauge or XRF use is performed and where licensed material may be stored other than those location(s) of use authorized on the license.

"Tenth-value layer (TVL)" or "TVL" means the thickness of a specified material that attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

"Termination of irradiation" means the stopping of irradiation in a fashion that will not permit continuance of irradiation without the resetting of operating conditions at the control panel.

"Test" means the process of verifying compliance with an applicable regulation.

"Therapeutic radiation machine" means X-ray x-ray or electron-producing equipment designed and used for external beam radiation therapy.

"These regulations" mean all parts of these regulations.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Tomogram" means the depiction of the X-ray x-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane which is identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose X-ray x-ray attenuation properties are imaged in a tomogram.

"Total effective dose equivalent" (TEDE) or "TEDE" means the sum of the effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) or "TODE" means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 12VAC5-481-1040.

"Traceable to a National Standard" (See "Instrument traceability" or "Source traceability").

"Transfer" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the physical relocation of NORM containing materials not directly associated with commercial distribution within a business's operation or between general or specific licensees. This term does not include a change in legal title to NORM containing materials that does not involve physical movement of those materials.

"Transport container" means a package that is designed to provide radiation safety and security when sealed sources are transported and which meets all applicable requirements of the United States Department of Transportation.

"Transport index (TI)" or "TI" means the dimensionless number, rounded up to the next tenth, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one meter (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 ft)).

"Treatment site" means the correct anatomical description of the area intended to receive a radiation dose, as described in a written directive.

"Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications.

"Tube" means an X-ray x-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

"Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

"Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in Table A-1 of 12VAC5-481-3770 or may be determined by procedures described in Table A-1 of 12VAC5-481-3770.

"Type B quantity" means a quantity of radioactive material greater than a Type A quantity.

"Underwater irradiator" means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

"Underwater radiography" means radiographic operations performed when the radiographic exposure device or radiation machine and/or related equipment are beneath the surface of the water.

"Uniform Low-Level Radioactive Waste Manifest" or "uniform manifest" means the combination of NRC Forms 540 and 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.

"Unirradiated uranium" means uranium containing not more than 2 x 103 Bq of plutonium per gram of uranium-235, not more than 9 x 106 Bq of fission products per gram of uranium-235, and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235.

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"Uranium—natural, depleted, enriched"

1. "Natural uranium" means uranium with the naturally occurring distribution of uranium isotopes, which is approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238.

2. "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

3. "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

"Uranium sinker bar" means a weight containing depleted uranium used to pull a logging tool down toward the bottom of a well.

"Useful beam" means the radiation emanating from that passes through the tube housing port or the radiation head and passing through and the aperture of the beam limiting beam-limiting device when the exposure controls are in a mode to cause the system to produce radiation switch or timer is activated.

"User seal check (fit check)" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for stepless adjustment of the X-ray x-ray field size at a given SID.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or one meter from any surface that the radiation penetrates.

"Virtual source" means a point from which radiation appears to originate.

"Visible area" means that portion of the input surface of the image receptor over which incident X-ray x-ray photons are producing a visible image.

"Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.

"Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in subdivisions 2, 3, and 4 of the definition of byproduct material.

"Waste collector" means an entity, operating under a specific license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.

"Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541.

"Waste generator" means an entity, operating under a license, who (i) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (ii) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste."

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Waste processor" means an entity, operating under a specific license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.

"Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).

"Wedge filter" means a filter that effects continuous change in transmission over all or a part of the useful beam.

"Week" means seven consecutive days starting on Sunday.

"Weighting factor (wT)" for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of wT are:

Organ Dose Weighting Factors

 

Organ or Tissue

wT

 

Gonads

0.25

 

Breast

0.15

 

Red bone marrow

0.12

 

Lung

0.12

 

Thyroid

0.03

 

Bone surfaces

0.03

 

Remainder

0.30a/

 

Whole Body

1.00b/

 

a/0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

b/For the purpose of weighting the external whole body dose for adding it to the internal dose, a single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

"Well-bore" means a drilled hole in which wireline service operations or subsurface tracer studies are performed.

"Well-logging" means all operations involving the lowering and raising of measuring devices or tools that may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well or adjacent formations.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Wireline" means a cable containing one or more electrical conductors that is used to lower and raise logging tools in the well-bore.

"Wireline service operation" means any evaluation or mechanical service that is performed in the well-bore using devices on a wireline.

"Worker" means an individual engaged in work under a license or registration issued by the agency and controlled by a licensee or registrant but does not include the licensee or registrant.

"Working level (WL)" or "WL" means any combination of short-lived radon daughters in one liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) or "WLM" means an exposure to one working level for 170 hours. Two thousand working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subdivision 6 below, containing the following information:

1. For any administration of quantities greater than 1.11 megabecquerels (30 mCi) of sodium iodide I-125 or I-131: the radionuclide, and dosage; or

2. For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration; or

3. For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; or

4. For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; or

5. For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, and total dose; or

6. For all other brachytherapy,

a. Prior to implantation: the radionuclide, number of sources, and source strengths; and

b. After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

"X-ray control" means a device that controls input power to the x-ray high-voltage generator or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The X-ray x-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray equipment" means an X-ray x-ray system, subsystem, or component thereof. Types of X-ray x-ray equipment are as follows:

1. "Mobile X-ray x-ray equipment" means X-ray x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.

2. "Portable X-ray x-ray equipment" means X-ray x-ray equipment designed to be hand-carried.

3. "Stationary X-ray x-ray equipment" means X-ray x-ray equipment that is installed in a fixed location.

"X-ray field" means that area of the intersection of the useful beam and any one of the sets of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate AKR is one-fourth of the maximum in the intersection.

"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the X-ray x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the X-ray x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray system" means an assemblage of components for the controlled production of X-rays x-rays. It includes minimally an X-ray x-ray high-voltage generator, an X-ray x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, image intensifier fluoroscopic image receptor, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube that is designed for the conversion of electrical energy into X-ray x-ray energy.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

12VAC5-481-290

12VAC5-481-290. Registration of radiation machine facilities.

Each person having a radiation machine facility shall:

1. Apply for registration of such facility with the agency within 30 days following installation of equipment. Application for registration shall be completed on forms furnished by the agency and shall contain all the information required by the form and accompanying instructions. Registrations filed with the agency prior to September 20, 2006, shall remain in effect until a renewal notice is issued by the agency pursuant to 12VAC5-481-310.

2. Designate on the application form an individual to be responsible for radiation protection;

3. Submit to the agency as part of any application for registration or renewal of registration one copy of each radiation survey or calibration report for which records are required to be maintained pursuant to 12VAC5-481-1590 12VAC5-481-1591 A 12 c. Records submitted once need not be submitted again for renewal of registration.

4. Have an initial inspection by a private or state inspector no later than 30 days after the registration of the equipment. Subsequent inspections shall be made periodically in accordance with other parts of these regulations or whenever the equipment is moved to a new location. The agency shall furnish a list of private inspectors.

12VAC5-481-340

12VAC5-481-340. Private inspector qualifications.

Any person desiring designation as a private inspector for diagnostic X-ray x-ray, mammographic or therapeutic X-ray x-ray and teletherapy machines must be qualified by training and experience to perform inspections or calibrations according to the following criteria and must submit to the agency a statement on the appropriate form certifying his specific qualifications. In order to maintain designation as a private inspector, the individual must maintain satisfactory performance of work performed in that capacity. The agency shall disqualify individuals any individual from this designation for just cause provided that a show-cause hearing has been held and the agency if the agency has determined that the individual has demonstrated unsatisfactory performance as a private inspector. The individual may request an informal hearing.

A. Private inspector, diagnostic X-ray x-ray (except mammography). The person must have adequate knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, and advise regarding radiation protection needs to assure compliance with Virginia Rules and Regulations for Ionizing Radiation as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Certification by one of the following: American Board of Radiology either in diagnostic or radiological physics, American Board of Health Physics in comprehensive practice, or the American Board of Medical Physics in diagnostic imaging physics.

b. Bachelor's degree in one of the physical sciences or engineering and three years of full-time experience in radiation safety including at least one year in diagnostic X-ray x-ray safety. Advanced degrees in related areas may be substituted for experience on an equal time basis, except that no substitution shall be allowed for the required one year of experience in diagnostic X-ray x-ray safety.

c. Those individuals listed as private inspectors immediately prior to September 20, 2006, shall be considered grandfathered.

2. Continuing qualifications:

a. Continuing education. Private inspectors must participate in continuing education programs relating to diagnostic X-ray x-ray, either by teaching or completing at least 15 continuing education units (CMEs) every three years.

b. Continuing experience. The private inspector must have inspected at least 10 diagnostic X-ray x-ray machines within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

B. Private inspector, therapeutic X-ray x-ray and teletherapy machines. The person must have adequate knowledge, training, and experience to calibrate a therapeutic X-ray x-ray  machine or teletherapy machine, perform inspections and to establish procedures for (and review the results of) spot-check measurements as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Be certified by the American Board of Radiology in:

(1) Therapeutic radiological physics;

(2) Roentgen-ray and gamma-ray physics;

(3) X-ray and radium physics;

(4) Radiological physics;

b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics;

c. Be certified by the Canadian College of Medical Physics; or

d. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 12VAC5-481-3400 A;, 12VAC5-481-3420 P;, 12VAC5-481-3430 T;, 12VAC5-481-3420 Q;, and 12VAC5-481-3430 U under the supervision of a radiation therapy physicist during the year of work experience.

Notwithstanding the provisions of 12VAC5-481-3390 D, certification pursuant to subdivisions B 1 a, b, or c of this section shall be required on or before July 1, 2007, for all persons currently qualifying as a radiation therapy physicist pursuant to subdivision B 1 d of this section.

2. Continuing qualifications.

a. Continuing education: Private inspectors must participate in continuing education programs relating to therapeutic X-ray x-ray and teletherapy machines, either by teaching or completing at least 15 continuing education units (CEUs) every three years.

b. Continuing experience: The private inspector must have inspected at least one therapeutic X-ray x-ray or teletherapy facilities and at least one therapeutic X-ray x-ray or teletherapy machine within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform an inspection without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

C. Private inspector, mammography. The person must have adequate knowledge, training, and experience to inspect mammography X-ray x-ray machines and facilities. All mammography private inspector conducting inspections of mammography facilities and providing oversight of the facility quality assurance program must meet one of the following tracks, either through the initial master's degree of higher route or the alternative initial bachelor's degree route:

1. Initial qualifications:

Master Route:

a. Be certified by the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP) in:

(1) Diagnostic radiological physics;

(2) Radiological physics; or

(3) Diagnostic imaging physics;

b. A master's degree or higher in a physical science with at least 20 semester hours or equivalent of graduate or undergraduate physics; and

c. Twenty contact hours of mammography facility training; and

d. The experience of conducting inspections of at least one mammography facility and a total of at least 10 mammography units.

Bachelor Route (must have been qualified before April 28, 1999):

a. A bachelor's degree in a physical science with at least 10 semester hours or equivalent of college level physics;

b. Forty contact hours of documented specialized training in conducting inspections of mammography facilities; and

c. The experience of conducting inspections of at least one mammography facility and a total of at least 20 mammography units. The training and experience requirements must be met after fulfilling the degree requirement.

2. Continuing qualifications.

a. Continuing education. At all times after the third anniversary of completion of the initial requirements of this section, the private inspector shall have taught or completed at least 15 continuing education units in mammography during the preceding three years.

b. Continuing experience. At all times after the first anniversary of the completion of the initial requirements of this section, the private inspector shall have inspected at least two mammography facilities and six machines in 24 months.

c. Before a private inspector may begin independently performing mammographic examinations using a new modality, that is, a modality other than one for which the physicist received training to qualify under this section, the inspector must receive at least eight hours of training in inspecting units with the new modality.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the mammography inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of three mammography facilities under the direct supervision of a private inspector who meets the qualifications of this section.

12VAC5-481-350

12VAC5-481-350. Assembler or transfer obligation.

A. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines or upon significant service or modification thereof of any radiation machine (such as tube inserts, generators, or collimators) in this state shall notify the agency within 15 days of:

1. The name and address of persons who have received these machines;

2. The manufacturer, model, and serial number of each radiation machine transferred; however, in the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report (Form FDA 2579) prepared in compliance with the requirements of the Food and Drug Administration's Federal Diagnostic X-ray Standard (21 CFR 1020.30(d)) shall be submitted and shall suffice in lieu of any other report by the assembler; and

3. The date of transfer of each radiation machine.

B. No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

12VAC5-481-1580

Part VI
Use Of Diagnostic X-Rays In The Healing Arts

12VAC5-481-1580. Purpose and scope. (Repealed.)

This part establishes requirements, for which a registrant is responsible, for use of diagnostic X-ray equipment by, or under the supervision of, an individual authorized by and licensed in accordance with state statutes to engage in the healing arts or veterinary medicine. The provisions of this part are in addition to, and not in substitution for, other applicable provisions of Parts I (12VAC5-481-10 et seq.); II (12VAC5-481-260 et seq.); IV (12VAC5-481-600 et seq.); and X (12VAC5-481-2250 et seq.) of this chapter. Some registrants may also be subject to the requirements of Parts IX (12VAC5-481-2140 et seq.) and XV (12VAC5-481-3380 et seq.) of this chapter.

12VAC5-481-1581

12VAC5-481-1581. Purpose and scope.

This part establishes requirements, for which a registrant is responsible, for use of diagnostic x-ray equipment and imaging systems by or under the supervision of an individual authorized by and licensed in accordance with Virginia law to engage in the healing arts or veterinary medicine. The provisions of this part are in addition to and not in substitution for other applicable provisions of this chapter.

12VAC5-481-1590

12VAC5-481-1590. General and administrative requirements. (Repealed.)

A. Radiation safety requirements. The registrant shall be responsible for directing the operation of the X-ray system(s) under his administrative control. The registrant or the registrant's agent shall assure that the requirements of these regulations are met in the operation of the X-ray system(s).

1. An X-ray system that does not meet the provisions of these regulations shall not be operated for diagnostic purposes.

2. Individuals who will be operating the X-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. The agency may use interview, observation and/or testing to determine compliance. The following are areas in which the agency considers it important that an individual have expertise for the competent operation of X-ray equipment:

a. Familiarization with equipment

(1) Identification of controls

(2) Function of each control

(3) How to use a technique chart

b. Radiation protection

(1) Collimation

(2) Filtration

(3) Gonad shielding and other patient protection devices, if used

(4) Restriction of X-ray tube radiation to the image receptor

(5) Personnel protection

(6) Grids

c. Image processing

(1) Film speed as related to patient exposure

(2) Image processing parameters

(3) Quality assurance program

d. Emergency procedures—termination of exposure in event of automatic timing device failure

e. Proper use of personnel dosimetry, if required

f. Understanding units of radiation

3. A chart shall be provided in the vicinity of the diagnostic X-ray system's control panel that specifies, for all examinations performed with that system, the following information:

a. Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

b. Reserved;

c. Reserved;

d. Source to image receptor distance to be used (except for dental intra-oral radiography);

e. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and

f. For mammography, indication of kVp/target/filter combination.

4. The registrant of a facility shall create and make available to X-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures. A copy of the written safety procedures shall be posted near each X-ray machine.

5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

b. The X-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material;

c. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers, or protective aprons of not less than 0.25 millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.

6. Gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

7. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

a. Exposure of an individual for training, demonstration, or other nonhealing arts purposes; and

b. Exposure of an individual for the purpose of healing arts screening except as authorized by subdivision A 11 of this section.

8. When a patient or film must be provided with auxiliary support during a radiation exposure:

a. Mechanical holding devices shall be used when the technique permits. The written safety procedures, required by subdivision A 4 of this section, shall list individual projections where holding devices cannot be utilized;

b. Written safety procedures, as required by subdivision A 4 of this section, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

c. The human holder shall be instructed in personal radiation safety and protected as required by subdivision A 5 of this section;

d. No individual shall be used routinely to hold film or patients;

e. In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material; and

f. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with X-ray operations and who are otherwise not shielded.

g. When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, that individual shall be protected by appropriate shielding devices, such as protective glove and apron, and he shall be so positioned that no part of his body will be struck by the useful beam. The radiation exposure of and individual used for this purpose shall be monitored and recorded. These records of radiation exposure must be maintained indefinitely for inspection by the agency.

9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

a. The speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intra-oral use in dental radiography.

b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality and, where applicable, shall not exceed the following standards:

EXPOSURE LIMITS FOR SELECTED PROJECTIONS

Using a method acceptable to the agency, the exposure measurement shall be determined in the center of the X-ray field at the location of the entrance skin of a standard patient, except for dental intraoral X-ray machines in which case the measurement shall be determined at the conetip. The technique factors selected shall be those used for routine radiography for an average size adult patient at that facility for that X-ray machine. At least one projection must be tested for each X-ray machine unless none of the projections listed are used. If an X-ray machine is used in both the manual and phototimed modes, then only the manual mode shall be tested. If the machine is used only in the phototimed mode, then this test is not required. An average size adult, for purposes of these regulations, is defined as a 5'8", 164 lb. adult male meeting the following anthropometric guidelines for the radiographic examination projection specified: PA Chest—Thorax—23 cm thickness; AP Abdomen and AP Lumbar Spine—Abdomen—23 cm thickness.

The exposure shall not exceed the following maximum exposure limits for the projections below:

Projection

Maximum Exposure

PA Chest

50 mR

AP Lumbar Spine

1400 mR

AP Abdomen

1100 mR

Dental Bitewing
Using D Speed Film

50 kVp

575 mR

55 kVp

500 mR

60 kVp

440 mR

65 kVp

400 mR

70 kVp

350 mR

75 kVp

260 mR

80 kVp

230 mR

85 kVp

200 mR

90 kVp

180 mR

95 kVp

160 mR

100 kVp

140 mR

Using E Speed Film

50 kVp

320 mR

55 kVp

270 mR

60 kVp

230 mR

65 kVp

200 mR

70 kVp

170 mR

75 kVp

140 mR

80 kVp

120 mR

85 kVp

105 mR

90 kVp

90 mR

95 kVp

80 mR

100 kVp

70 mR

c. Portable or mobile X-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary X-ray installation.

d. X-ray systems subject to 12VAC5-481-1620 shall not be utilized in procedures where the source to patient distance is less than 30 centimeters, except for veterinary systems.

e. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:

(1) Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray;

(2) If of the focused type, be of the proper focal distance for the SID's being used.

10. All individuals who are associated with the operation of an X-ray system are subject to the requirements of 12VAC5-481-640, 12VAC5-481-680, 12VAC5-481-700 and 12VAC5-481-710.

11. Healing arts screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the following information. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified.

INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS SCREENING

Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this state;

b. Diseases or conditions for which the X-ray examinations are to be used in diagnoses;

c. A detailed description of the X-ray examinations proposed in the screening program;

d. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the X-ray examinations;

f. An evaluation by a private inspector of the X-ray system(s) to be used in the screening program. The evaluation by the private inspector shall show that such system(s) do satisfy all requirements of these regulations. The evaluation shall include a measurement of patient exposures from the X-ray examinations to be performed;

g. A description of the diagnostic X-ray quality control program;

h. A copy of the technique chart for the X-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the X-ray system(s);

j. The qualifications of the individual who will be supervising the operators of the X-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the individual who will interpret the radiograph(s);

l. A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated;

m. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the X-ray examinations;

n. An indication of the frequency of screening and the duration of the entire screening program.

12. Information and maintenance record and associated information. The registrant shall maintain the following information for each X-ray system for inspection by the agency:

a. Model and serial numbers of all major components, and user's manuals for those components;

b. Tube rating charts and cooling curves;

c. Records of surveys, calibrations, maintenance, and modifications performed on the X-ray system(s); and

d. A copy of all correspondence with this agency regarding that X-ray system.

13. X-ray utilization log. Except for veterinary facilities, each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded.

14. The registrant shall maintain a list of X-ray machine operators for each facility. The following information will be maintained on the list:

The name of the X-ray machine operator. Operators must be licensed by the Department of Health Professions where X-rays are used within the scope of practice or be certified by the ARRT, or an individual enrolled in an accredited program for radiologic technology and under the supervision of a licensed or certified radiological technologist, and if a dental assistant, comply with the Board of Dentistry's radiation certification requirements in 18VAC60-20-195.

B. X-ray film processing facilities and practices.

1. Each installation using a radiographic X-ray system and using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

a. Manually developed film:

(1) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

(2) The temperature of solutions in the tanks shall be maintained within the range of 60°F to 80°F (16°C to 27°C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart that must be posted in the darkroom:

 

Thermometer Reading (Degrees)

Minimum Developing Time (Minutes)

°C

°F

26.7

80

2

26.1

79

2

25.6

78

22

25.0

77

22

24.4

76

3

23.9

75

3

23.3

74

32

22.8

73

32

22.2

72

4

21.7

71

4

21.1

70

42

20.6

69

42

20.0

68

5

19.4

67

52

18.9

66

52

18.3

65

6

17.8

64

62

17.2

63

7

16.7

62

8

16.1

61

82

15.6

60

92

(3) Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

b. Automatic processors and other closed processing systems:

(1) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using the following chart:

Developer Temperature

Minimum Immersion Timea (Seconds)

°C

°F

35.5

96

19

35

95

20

34.5

94

21

34

93

22

33.5

92

23

33

91

24

32

90

25

31.5

89

26

31

88

27

30.5

87

28

30

86

29

29.5

85

30

a Immersion time only, no crossover time included. 

(2) The specified developer temperature and immersion time shall be posted in the darkroom or on the automatic processor.

c. Processing deviations from the requirements of subdivision 1 of this subsection shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).

2. Other requirements.

a. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

b. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from one to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

c. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

d. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

e. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.

f. Outdated X-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.

g. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

h. Living and deceased patient's films (diagnostic images) shall be maintained for a minimum of five years. Films for minors shall be maintained for a minimum of five years beyond their 18th birthday.

C. Information to be submitted to the agency. The registrant shall submit to the agency a copy of all surveys, calibrations and inspections performed by a private inspector within 30 days of completion of the survey or calibration.

D. Information to be submitted by the private inspector to the registrant. The private inspector shall provide the inspection report to the registrant within 14 days of the completion of the inspection. A summary and/or recommendations shall be included with this report. The private inspector shall notify the registrant of any noncompliances that need corrective action.

12VAC5-481-1591

12VAC5-481-1591 General and administrative requirements

A. Radiation safety requirements. The registrant shall be responsible for directing the operation of the x-ray system under his administrative control. The registrant or the registrant's agent shall assure that the requirements of this chapter are met in the operation of the x-ray system or systems.

1. An x-ray system that does not meet the provisions of this chapter shall not be operated for diagnostic purposes.

2. Individuals who will be operating the x-ray systems shall meet the qualifications of this part to conduct the practice of radiologic technology.

3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel that specifies, for all examinations performed with that system, the following information:

a. Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

b. Type and size of the image receptor to be used;

c. Type and size of the image receptor combination to be used, if any;

d. Source to image receptor distance to be used (except for dental intraoral radiography);

e. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and

f. For mammography, indication of kVp/target/filter combination.

4. The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel, or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 mm lead equivalent material;

b. The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent material; and

c. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 mm lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.

6. Gonad shielding of not less than 0.5 mm lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

7. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

a. Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

b. Exposure of an individual for the purpose of healing arts screening except as authorized by subdivision 11 of this subsection.

8. When a patient or image receptor must be provided with auxiliary support during a radiation exposure:

a. Mechanical holding devices shall be used when the technique permits. The written safety procedures, as required by subdivision 4 of this subsection, shall list individual projections where holding devices cannot be utilized;

b. Written safety procedures, as required by subdivision 4 of this subsection, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

c. The human holder shall be instructed in personal radiation safety and protected as required by subdivision 5 of this subsection;

d. No individual shall be used routinely to hold image receptor or patients;

e. In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 mm lead equivalent material; and

f. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection for all personnel who are involved with x-ray operations and who are otherwise not shielded.

9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

a. The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.

b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

c. Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.

d. X-ray systems subject to 12VAC5-481-1621 shall not be utilized in procedures where the source to patient distance is less than 30 cm, except for veterinary systems.

e. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:

(1) Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray; and

(2) If the grid is of the focused type, be of the proper focal distance for the SIDs being used.

10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of 12VAC5-481-640, 12VAC5-481-700, and 12VAC5-481-710.

11. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the agency. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this state;

b. Diseases or conditions for which the x-ray examinations are to be used in diagnoses;

c. A description of the x-ray examinations proposed in the screening program, i.e., type and number of views;

d. Description of the population to be examined in the screening program, i.e., age range, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;

f. An evaluation by a qualified medical physicist of the x-ray system or systems to be used in the screening program. The evaluation shall include the following:

(1) Documentation that such systems satisfy all requirements of this chapter; and

(2) Measurement of patient exposures from the x-ray examinations to be performed;

g. A description of the diagnostic x-ray quality control program;

h. A copy of the technique chart for the x-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the x-ray system or systems;

j. The qualifications of the individual who will be supervising the operators of the x-ray system or systems. The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the practitioner licensed in the state who will interpret the radiograph;

l. Procedures to be used in advising the individuals screened and their practitioners of the healing arts or health care providers of the results of the screening procedure and any further medical needs indicated;

m. Procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;

n. Frequency of screening of individuals; and

o. The duration of the screening program.

12. The registrant shall maintain the following information and maintenance record for each x-ray system for inspection by the agency:

a. Model and serial numbers of all major components, and user's manuals for those components;

b. Tube rating charts and cooling curves;

c. Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system or systems; and

d. A copy of all correspondence with the agency regarding that x-ray system.

13. Except for veterinary facilities, each facility shall maintain an x-ray utilization log containing the patient's name, the type of examination, and the date the examination was performed.

14. The registrant shall maintain a list of x-ray operators for each facility. Operators must be licensed by the Department of Health Professions where x-rays are used within the scope of practice or be certified by the American Registry of Radiological Technologists (ARRT), or be an individual enrolled in an accredited program for radiologic technology and under the supervision of a licensed or certified radiological technologist, and if a dental assistant, comply with the Board of Dentistry's radiation certification requirements in 18VAC60-20-195.

B. X-ray film processing facilities and practices.

1. Each installation using a radiographic x-ray system and analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

a. Manually developed film.

(1) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

(2) The temperature of solutions in the tanks shall be maintained within the range of 60°F to 80°F (16°C to 27°C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer or, in the absence of such recommendations, with the following time-temperature chart:

 

Time-Temperature Chart

 

Thermometer Reading (Degrees)

Minimum Developing Time (Minutes)

 

°C

°F

 

 

26.7

80

2

 

26.1

79

2

 

25.6

78

2-1/2

 

25.0

77

2-1/2

 

24.4

76

3

 

23.9

75

3

 

23.3

74

3-1/2

 

22.8

73

3-1/2

 

22.2

72

4

 

21.7

71

4

 

21.1

70

4-1/2

 

20.6

69

4-1/2

 

20.0

68

5

 

19.4

67

5-1/2

 

18.9

66

5-1/2

 

18.3

65

6

 

17.8

64

6-1/2

 

17.2

63

7

 

16.7

62

8

 

16.1

61

8-1/2

 

15.6

60

9-1/2

(3) Devices shall be utilized that will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

b. Automatic processors and other closed processing systems. Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. In the absence of such recommendations, the film shall be developed using the following chart:

 

Developer Temperature

Minimum Immersion Time*

 

°C

°F

Seconds

 

35.5

96

19

 

35

95

20

 

34.5

94

21

 

34

93

22

 

33.5

92

23

 

33

91

24

 

32

90

25

 

31.5

89

26

 

31

88

27

 

30.5

87

28

 

30

86

29

 

29.5

85

30

 

*Immersion time only, no crossover time included.

Processing deviations from the requirements of this subdivision shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing and special rapid chemistry).

2. Other requirements.

a. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

b. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-ray radiation sufficient to produce an optical density from one to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

c. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

d. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

e. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.

f. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.

g. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

h. Living and deceased patients' diagnostic images shall be maintained for a minimum of five years. Diagnostic images for minors shall be maintained for a minimum of five years beyond their 18th birthday.

C. The registrant shall submit to the agency a copy of all surveys, calibrations, and inspections performed by a private inspector within 30 days of completion of the survey, calibration, or inspection.

D. The private inspector shall provide the inspection report to the registrant within 14 days of the completion of the inspection. A summary or recommendation shall be included with this report. The inspector shall notify the registrant of any noncompliances that need corrective action.

E. Violations identified as "serious" must be corrected within 30 days. Certification of the unit will not be issued until the violation is corrected. Violations identified as "non-serious" shall be corrected before the next inspection cycle. Uncorrected "non-serious" violations will become "serious" and require immediate correction.

12VAC5-481-1600

12VAC5-481-1600. General requirements for all diagnostic X-ray systems. (Repealed.)

In addition to other requirements of this part, all diagnostic X-ray systems shall meet the following requirements:

1. Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."

2. Battery charge indicator. On battery-powered X-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

3. Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 25.8 μC/kg (100 milliroentgens) in one hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

4. Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 0.5 μC/kg (2 milliroentgens) in one hour at five centimeters from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

5. Beam quality.

a. Half-value layer.

(1) The half-value layer of the useful beam for a given X-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an X-ray tube potential that is not listed in Table I, linear interpolation or extrapolation may be made.

TABLE I

Design Operating Range (kVp)

Measured Potential (kVp)

Half-Value Layer In mm Aluminum

Dental Intra-Oral Manufactured Before Aug. 1, 1974, and on or After Dec. 1, 1980

All Other Diagnostic X-ray Systems

Below 51

30

N/A

0.3

 

40

N/A

0.4

 

50

1.5

0.5

51 to 70

51

1.5

1.2

 

60

1.5

1.3

 

70

1.5

1.5

Above 70

71

2.1

2.1

 

80

2.3

2.3

 

90

2.5

2.5

 

100

2.7

2.7

 

110

3.0

3.0

 

120

3.2

3.2

 

130

3.5

3.5

 

140

3.8

3.8

 

150

4.1

4.1

(2) For capacitor energy storage equipment, compliance with the requirements of subdivision 5 a of this section shall be determined with the system fully charged and a setting of 10 mAs for each exposure.

(3) The required minimal half-value layer of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient.

b. Filtration controls. For X-ray systems that have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration necessary to produce the HVL required by subdivision 5 a of this section is in the useful beam for the given kVp that has been selected.

6. Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the X-ray control panel and at or near the tube housing assembly that has been selected.

7. Mechanical support of tube head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.

8. Technique indicators.

a. The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.

b. The requirement of subdivision 8 a of this section may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

9. Maintaining compliance. Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the federal X-ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

10. Locks. All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.

11. Mechanical timers. The use of a mechanical timer is prohibited.

12VAC5-481-1601

12VAC5-481-1601. General requirements for all diagnostic x-ray systems.

In addition to other requirements of this part, all diagnostic x-ray systems shall meet the following requirements:

1. Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view:

"WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed."

2. Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (100 milliroentgen (mR) exposure) in one hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

3. Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (two milliroentgens exposure) in one hour at five cm from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

4. Beam quality half-value layer (HVL).

a. The HVL of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 (i) under the heading "Specified Dental Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; (ii) under the heading "I-Other X-Ray Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and (iii) under the heading "II-Other X-Ray Systems" for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006.  If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table 1, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector that will prevent x-ray emissions if the minimum required filtration is not in place.

 

TABLE 1

 

X-Ray Tube Voltage (kilovolt peak)

 

Design Operating Range

Measured Operating Potential

Minimum HVL (mm in Aluminum)

 

Specified Dental Systems1

I-Other X-Ray Systems2

II-Other X-Ray Systems3

 

Below 51

30

1.5

0.3

0.3

 

 

40

1.5

0.4

0.4

 

 

50

1.5

0.5

0.5

 

51 to 70

51

1.5

1.2

1.3

 

 

60

1.5

1.3

1.5

 

 

70

1.5

1.5

1.8

 

Above 70

71

2.1

2.1

2.5

 

 

80

2.3

2.3

2.9

 

 

90

2.5

2.5

3.2

 

 

100

2.7

2.7

3.6

 

 

110

3.0

3.0

3.9

 

 

120

3.2

3.2

4.3

 

 

130

3.5

3.5

4.7

 

 

140

3.8

3.8

5.0

 

 

150

4.1

4.1

5.4

 

1 Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980.

2 Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006.

3 All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006.

b. Optional filtration. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube or tubes with a continuous output of one kilowatt or more and an anode heat storage capacity of one million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions in Table 1. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

c. Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

5. Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2, which are used between the patient and the image receptor, shall not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 for the potential. This requirement applies to front panel or panels of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.

 

TABLE 2

 

Item

Maximum Aluminum Equivalent (mm)

 

Front panel(s) of cassette holders (total of all)

1.2

 

Film panel(s) of film changer (total of all)

1.2

 

Cradle

2.3

 

Tabletop, stationary, without articulated joints

1.2

 

Tabletop, movable, without articulated joints (including stationary subtop)

1.7

 

Tabletop, with radiolucent panel having one articulated joint

1.7

 

Tabletop, with radiolucent panel having two or more articulated joints

2.3

 

Tabletop, cantilevered

2.3

 

Tabletop, radiation therapy simulator

5.0

6. Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

7. Modification of certified diagnostic x-ray components and systems.

a. Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this part.

b. The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or a component to comply with the applicable requirements of this part. The owner who causes such modification need not submit the reports required by this part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this part.

8. Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

9. Mechanical support of tube head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.

10. Technique indicators.

a. For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors that are set prior to the exposure shall be indicated.

b. The requirement of subdivision 10 a of this subsection may be met by permanent markings on equipment having fixed technique factors.  Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

11. Maintaining compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

12. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

13. Mechanical timers. The use of mechanical timers is prohibited.

12VAC5-481-1610

12VAC5-481-1610. Fluoroscopic X-ray systems. (Repealed.)

All fluoroscopic X-ray systems used shall be image intensified and meet the following requirements:

1. Limitation of useful beam.

a. Primary barrier.

(1) The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID.

(2) The X-ray tube used for fluoroscopy shall not produce X-rays unless the barrier is in position to intercept the entire useful beam.

b. Fluoroscopic beam limitation.

(1) For certified fluoroscopic systems with or without a spot film device, neither the length nor the width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

(2) For uncertified fluoroscopic systems with a spot film device, the X-ray beam with the shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the largest spot film size for which the device is designed. Measurements shall be made at the minimum SID available but at no less than 20 centimeters table top to the film plane distance.

(3) For uncertified fluoroscopic systems without a spot film device, the requirements of subdivision b (1) of this section apply.

(4) Other requirements for fluoroscopic beam limitation:

(a) Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the X-ray field;

(b) All equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with either stepless adjustment of the X-ray field or with means to further limit the X-ray field size at the plane of the image receptor to 125 square centimeters or less;

(c) If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum attainable to a field size of five centimeters by five centimeters or less;

(d) For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor;

(e) For noncircular X-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the X-ray field that pass through the center of the visible area of the image receptor.

c. Spot-film beam limitation. Spot-film devices shall meet the following requirements:

(1) Means shall be provided between the source and the patient for adjustment of the X-ray field size in the plane of the film to the size of that portion of the film that has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the X-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the X-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;

(2) Neither the length nor the width of the X-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4.0% of the SID;

(3) It shall be possible to adjust the X-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, five centimeters by five centimeters;

(4) The center of the X-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2.0% of the SID; and

(5) On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

d. Override. If a means exists to override any of the automatic X-ray field size adjustments required in subdivisions 1 b and c of this section that means:

(1) Shall be designed for use only in the event of system failure;

(2) Shall incorporate a signal visible at the fluoroscopist's position that will indicate whenever the automatic field size adjustment is overridden; and

(3) Shall be clearly and durably labeled as follows:

FOR X-RAY FIELD LIMITATION SYSTEM FAILURE

2. Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the X-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

3. Exposure rate limits.

a. Entrance exposure rate allowable limits.

(1) Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 2.6 mC/kg (10 roentgens) per minute at the point where the center of the useful beam enters the patient, except:

(a) During recording of fluoroscopic images; or

(b) When an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 5.2 mC/kg-min (20 R/min) at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(2) Fluoroscopic equipment that is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current that will result in a exposure rate in excess of 1.3 mC/kg (5 roentgens) per minute at the point where the center of the useful beam enters the patient, except:

(a) During recording of fluoroscopic images; or

(b) When an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(3) Compliance with the requirements of subdivision 3 of this section shall be determined as follows:

(a) If the source is below the X-ray table, the exposure rate shall be measured one centimeter above the tabletop or cradle;

(b) If the source is above the X-ray table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

(c) For a C-arm type of fluoroscope, the exposure rate shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly;

(d) For a lateral type fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the X-ray table and in the direction of the X-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral X-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the X-ray table.

b. Periodic measurement of entrance exposure rate shall be performed by a private inspector for both typical and maximum values as follows:

(1) Such measurements shall be made annually or after any maintenance of the system that might affect the exposure rate;

(2) Results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscope and in the record required in 12VAC5-481-1590 A 12 c. The measurement results shall be stated in coulombs per kilogram (roentgens) per minute and include the technique factors used in determining such results. The name of the individual performing the measurements and the date the measurements were performed shall be included in the results;

(3) Conditions of periodic measurement of typical entrance exposure rate are as follows:

(a) The measurement shall be made under the conditions that satisfy the requirements of subdivision 3 a (3) of this section;

(b) The kVp, mA, and/or other selectable parameters shall be adjusted to those settings typical of clinical use on a 23 cm thick abdominal patient;

(c) The X-ray system that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce a milliamperage and/or kilovoltage to satisfy the conditions of subdivision 3 b (3) (b) of this section.

(4) Conditions of periodic measurement of maximum entrance exposure rate are as follows:

(a) The measurement shall be made under the conditions that satisfy the requirements of subdivision 3 a (3) of this setion1;

(b) The kVp, mA and/or other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate;

(c) The X-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce the maximum entrance exposure rate of the system.

4. Barrier transmitted radiation rate limits.

a. The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed 0.5 %v(508)%E2%vC/kg (2 milliroentgens) per hour at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each mC/kg (roentgen) per minute of entrance exposure rate.

b. Measuring compliance of barrier transmission.

(1) The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(2) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

(3) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

(4) Movable grids and compression devices shall be removed from the useful beam during the measurement.

5. Indication of potential and current. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated.

6. Source-to-skin distance. The SSD shall not be less than:

a. Thirty-eight centimeters on stationary fluoroscopic systems manufactured on or after August 1, 1974;

b. Thirty-five and one-half centimeters on stationary fluoroscopic systems manufactured prior to August 1, 1974;

c. Thirty centimeters on all mobile fluoroscopes;

d. Twenty centimeters for all mobile fluoroscopes when used for specific surgical applications; or

e. Nine centimeters for all portable fluoroscopes when used for special applications.

7. Fluoroscopic timer.

a. Means shall be provided to preset the cumulative on-time of the fluoroscopic X-ray tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting.

b. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while X-rays are produced until the timing device is reset.

8. Control of scattered radiation.

a. Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation that originates from under the table. The attenuation required shall be not less than 0.25 millimeter lead equivalent.

b. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:

(1) Is at least 120 centimeters from the center of the useful beam; or

(2) The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 12VAC5-481-1590 A 5.

c. The agency may grant exemptions to subdivision 8 b of this section where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption. The following is a suggested list of fluoroscopic procedures where such exemptions will be automatically granted: angiograms, arthrograms, biliary drainage procedures, fluoroscopic biopsy procedures, myelograms, percutaneous cholangiograms, percutaneous nephrostomies, sinograms or fistulograms, t-tube cholangiograms, interventional cardiac catheterization, and interventional special procedures.

9. Spot-film exposure reproducibility. Fluoroscopic systems equipped with spot-film (radiographic) mode shall meet the exposure reproducibility requirements of 12VAC5-481-1620 D when operating in the spot film mode.

10. Radiation therapy simulation systems. Radiation therapy simulation systems shall be exempt from all the requirements of subdivision 3 of this section. In addition, these systems shall be exempt from:

a. The requirements of subdivisions 1 and 4 of this section provided such systems are designed and used in such a manner that no individual other than the patient is in the X-ray room during periods of time when the system is producing X-rays; and

b. The requirements of subdivision 7 of this section if such systems are provided with a means of indicating the cumulative time that an individual patient has been exposed to X-rays. Procedures shall require in such cases that the timer be reset between examinations.

11. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all fluoroscopic X-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.

12VAC5-481-1611

12VAC5-481-1611. Fluoroscopic equipment.

A. The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

B. Primary protective barrier.

1. Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3% of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.

2. Measuring compliance. The AKR shall be measured in accordance with subsection E of this section. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

C. Field limitation.

1. Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with subdivisions 4 and 5 of this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

2. Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of subdivisions 4 and 5 of this subsection. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or capability of a visible area of greater than 300 square cm, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square cm shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five cm by five cm. This paragraph does not apply to non-image-intensified fluoroscopy.

3. Non-image-intensified fluoroscopy. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.

4. Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

a. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

(1) Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

(2) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

b. For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:

(1) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80% of the area of the x-ray field overlaps the visible area of the image receptor; or

(2) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two cm.

5. Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:

a. Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

b. The error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

"For X-Ray Field Limitation System Failure"

D. Activation of tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure or exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.

E. Air kerma rates. For fluoroscopic equipment, the following requirements apply:

1. Fluoroscopic equipment manufactured before May 19, 1995.

a. Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

b. Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

c. Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) in either mode at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

d. Equipment may be modified in accordance with this part to comply with subdivision 2 of this subsection. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

e. Exceptions:

(1) During recording of fluoroscopic images; or

(2) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of any of the rates specified in subdivisions 1 a, b, and c of this subsection at the measurement point specified in subdivision 3 of this subsection, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.

2. Fluoroscopic equipment manufactured on or after May 19, 1995.

a. Equipment shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Provision or manual selection of technique factors may be provided.

b. Equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 2 c of this subsection.

c. Exceptions:

(1) For equipment manufactured prior to June 10, 2006, during the recording of images from the fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.

(2) For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image or images after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.

(3) When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

3. Measuring compliance. Compliance with this subsection shall be determined as follows:

a. If the source is below the x-ray table, the AKR shall be measured at one cm above the tabletop or cradle.

b. If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

c. In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.

d. In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.

e. In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.

4. Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this subsection when used for therapy simulation purposes.

F. Reserved.

G. Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.

H. Source-skin distance.

1. Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this subsection, provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.

2. For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.

I. Fluoroscopic irradiation time, display, and signal.

1. Fluoroscopic equipment manufactured before June 10, 2006.

a. Equipment shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this subdivision. When the equipment is modified, it shall bear a label indicating the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

b. As an alternative to the requirements of this subsection, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.

2. For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

a. A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply:

(1) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds.

(2) The fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset.

(3) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.

b. A signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.

J. Mobile and portable fluoroscopes. In addition to the other requirements of this subsection, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

K. Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.

1. For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.

2. For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.

3. Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

L. Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:

1. When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.

2. The cumulative air kerma in units of mGy shall be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds.

3. The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.

4. The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.

a. For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in subdivision E 3 a or E 3 e of this section.

b. For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.

5. Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

6. The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35% over the range of six mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three seconds.

M. Control of scattered radiation.

1. Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation that originates from under the table. The attenuation required shall be not less than 0.25 mm lead equivalent.

2. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:

a. Is at least 120 centimeters from the center of the useful beam; or

b. The radiation has passed through not less than 0.25 mm lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 12VAC5-481-1591 A 5.

3. The agency may grant exemptions to subdivision 2 of this subsection where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption.

N. Operator qualifications. The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist or equivalent be allowed to operate fluoroscopic x-ray systems.

O. Equipment operation.

1. All imaging formed by the use of fluoroscopic x-ray systems shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

2. The operation of fluoroscopic x-ray systems by radiologic technologists or equivalent shall be performed under the direct supervision of a licensed practitioner of the healing arts.

3. Radiologic technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or radiologic technologist as specified in subsection N of this section.

4. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5. Facilities shall maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record shall include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.

P. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all fluoroscopic x-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.

12VAC5-481-1620

12VAC5-481-1620. Radiographic systems other than fluoroscopic, dental intraoral, or computed tomography X-ray systems. (Repealed.)

A. Beam limitation, except mammographic systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting device meeting manufacturer's specifications and the requirements of 12VAC5-481-1620 H 2 has been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge).

1. General purpose stationary and mobile X-ray systems, including veterinary systems (other than portable) installed after September 20, 2006.

a. Only X-ray systems provided with means for independent stepless adjustment of at least two dimensions of the X-ray field shall be used.

b. A method shall be provided for visually defining the perimeter of the X-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam.

c. The agency may grant an exemption on noncertified X-ray systems to subdivisions 1 a and b of this subsection provided the registrant makes a written application for such exemption and in that application:

(1) Demonstrates it is impractical to comply with subdivisions 1 a and b of this subsection; and

(2) The purpose of subdivisions 1 a and b of this subsection will be met by other methods.

2. Additional requirements for stationary general purpose X-ray systems. In addition to the requirements of subdivision 1 of this subsection, stationary general purpose X-ray systems, both certified and noncertified, shall meet the following requirements:

a. A method shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, to align the center of the X-ray field with respect to the center of the image receptor to within 2.0% of the SID, and to indicate the SID to within 2.0%;

b. The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and

c. Indication of field size dimensions and SID's shall be specified in inches and/or centimeters, and shall be such that aperture adjustments result in X-ray field dimensions in the plane of the image receptor that correspond to those indicated by the beam-limiting device to within 2.0% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.

3. X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the X-ray field with the center of the image receptor to within 2.0% of the SID, or shall be provided with means to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.

4. X-ray systems other than those described in subdivisions 1 through 3 of this subsection, and veterinary systems installed prior to September 20, 2006, and all portable veterinary X-ray systems.

a. Means shall be provided to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2.0% of the SID when the axis of the X-ray beam is perpendicular to the plane of the image receptor.

b. Means shall be provided to align the center of the X-ray field with the center of the image receptor to within 2.0% of the SID, or means shall be provided to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. Compliance shall be determined with the axis of the X-ray beam perpendicular to the plane of the image receptor.

c. Subdivisions 4 a and b of this subsection may be met with a system that meets the requirements for a general purpose X-ray system as specified in subdivision 1 of this subsection or, when alignment means are also provided, may be met with either:

(1) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

(2) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

B. Radiation exposure control.

1. Exposure initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.

2. Exposure indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

3. Exposure termination. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. Except for dental panoramic systems, termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."

a. Manual exposure control. An X-ray control shall be incorporated into each X-ray system such that an exposure can be terminated by the operator at any time except for:

(1) Exposure of two seconds or less; or

(2) During serial radiography when means shall be provided to permit completion of any single exposure of the series in process.

b. Automatic exposure controls. When an automatic exposure control is provided:

(1) Indication shall be made on the control panel when this mode of operation is selected;

(2) If the X-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two pulses;

(3) The minimum exposure time for all equipment other than that specified in subdivision 3 b (2) of this subsection shall be equal to or less than one-sixtieth (1/60) second or a time interval required to deliver five mAs, whichever is greater;

(4) Either the product of peak X-ray tube potential, current, and exposure time shall be limited to not more than 60 kWs per exposure, or the product of X-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except that, when the X-ray tube potential is less than 50 kVp, the product of X-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and

(5) A visible signal shall indicate when an exposure has been terminated at the limits required by subdivision 3 b (4) of this subsection, and manual resetting shall be required before further automatically timed exposures can be made.

4. Exposure duration (timer) linearity. For systems having independent selection of exposure time settings, the average ratios (Xi) of exposure to the indicated timer setting, in units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:

(X1-X2) 0.1 (X1 + X2)

where X1 and X2 are the average C kg-1s-1 (mR/s) values.

5. Exposure control location. The X-ray exposure control shall be so placed that the operator can view the patient while making any exposure.

6. Operator protection, except veterinary systems, bone densitometers, and other self-contained machines whose design was approved by the FDA.

a. Stationary systems. Stationary X-ray systems shall be required to have the X-ray exposure control permanently mounted behind a protected barrier so that the operator can remain behind that protected barrier during the entire exposure. Where it is impractical to stand behind a protected barrier, dental panographic and podiatry X-ray systems may, as an alternative, be provided with means to allow the operator to be at least nine feet from the tube housing assembly during exposures.

b. Mobile and portable systems. Mobile and portable X-ray systems that are:

(1) Used continuously for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of subdivision 6 a of this subsection;

(2) Used for less than one week at the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during the exposure.

7. Operator protection for veterinary systems. All stationary, mobile or portable X-ray systems used for veterinary work shall be provided with either a two meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during exposures.

C. Source-to-skin distance. All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 centimeters, except for veterinary systems.

D. Reproducibility for Exposure and Time. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.10. This requirement applies to clinically used techniques.

E. Radiation from capacitor energy storage equipment in standby status. Radiation emitted from the X-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of 0.5 %v(508)%E2%vC/kg (2 milliroentgens) per hour at five centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.

F. Accuracy. Deviation of measured technique factors from indicated values of kVp and exposure time shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed 10% of the indicated value for kVp and 10% for time.

G. mA/mAs linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed X-ray tube potential within the range of 40% to 100% of the maximum rated:

1. Equipment having independent selection of X-ray tube current (mA). The average ratios (Xi) of exposure to the indicated milliampere-seconds product (C kg-1 mAs-1 (or mR/mAs)) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum:

X1-X2 < 0.10 (X1+X2)

where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of two where the tube current selection is continuous.

2. Equipment having a combined X-ray tube current-exposure time product (mAs) selector, but not a separate tube current (mA) selector. The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum:

X1-X2 < 0.10 (X1+X2)

where X1 and X2 are the average values obtained at any two mAs selector settings, or at two settings differing by no more than a factor of two where the mAs selector provides continuous selection.

3. Measuring compliance. Determination of compliance shall be based on four exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the X-ray tube manufacturer.

H. Additional requirements. Diagnostic X-ray systems shall be required to comply with the following additional requirements.

1. Beam limitation for stationary and mobile general purpose X-ray systems.

a. There shall be provided a means of stepless adjustment of the size of the X-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than five centimeters by five centimeters.

b. When a light localizer is used to define the X-ray field, it shall provide an average illumination of not less than 120 lux or 10 footcandles at 100 centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from this requirement.

2. Beam limitation and alignment on stationary general purpose X-ray systems equipped with PBL. If PBL is being used, the following requirements shall be met:

a. PBL shall prevent the production of X-rays when:

(1) Either the length or width of the X-ray field in the plane of the image receptor differs, except as permitted by subdivision 2 c of this subsection, from the corresponding image receptor dimensions by more than 3.0% of the SID; or

(2) The sum of the length and width differences as stated in subdivision 2 a (1) of this subsection without regard to sign exceeds 4.0% of the SID;

b. Compliance with subdivision 2 a of this subsection shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. Compliance shall be determined no sooner than five seconds after insertion of the image receptor;

c. The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters shall be equal to or less than five centimeters by five centimeters;

d. The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in subdivision 2 a of this subsection, then any change of image receptor size or SID must cause the automatic return.

3. Beam limitation for portable X-ray systems. Beam limitation for portable X-ray systems shall meet the beam limitation requirements of subdivisions A 1 or H 2 of this section.

I. Tube stands for portable X-ray systems. A tube stand or other mechanical support shall be used for portable X-ray systems, so that the X-ray tube housing assembly need not be hand held during exposures unless the system is specifically designed to be handheld.

J. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all X-ray machines covered by this section in order to assure compliance with the regulations, except that bone densitometers and X-ray machines used in the practice of podiatry or dentistry shall be surveyed every three years. The surveys shall be performed by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection.

12VAC5-481-1621

12VAC5-481-1621. Radiographic equipment.

A. Control and indication of technique factors.

1. Visual indication. The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls are used, in which case the technique factors that are set prior to the exposure shall be indicated. On equipment having fixed technique factors, this requirement may be met by permanent markings. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

2. Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

a. Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

b. During serial radiography, the operator shall be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in process.

3. Automatic exposure controls. When an automatic exposure control is provided:

a. Indication shall be made on the control panel when this mode of operation is selected;

b. When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver five milliampere-seconds (mAs), whichever is greater;

c. Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and

d. A visible signal shall indicate when an exposure has been terminated at the limits described in subdivision 3 c of this subsection, and manual resetting shall be required before further automatically timed exposures can be made.

4. Accuracy. Deviation of technique factors from indicated values shall not exceed the limits given by the manufacturer. In the absence of manufacturer's limits, the deviation shall not exceed 10% of the indicated value for kVp and time.

B. Reproducibility. The following requirements shall apply when the equipment is operated on an adequate power supply as specified by the manufacturer:

1. Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.10.

2. Measuring compliance. Determination of compliance shall be based on 10 consecutive measurements taken within a time period of one hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within ±1 of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than one-tenth second per exposure on all other equipment.

C. Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer in accordance with 21 CFR Part 1020 for any fixed x-ray tube potential within the range of 40% to 100% of the maximum rated.

1. Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is:

|X1 – X2| ≤ 0.10(X1 + X2)

where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

2. Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is:

|X1 – X2| ≤ 0.10(X1 + X2)

where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

3. Measuring compliance. Determination of compliance shall be based on 10 exposures, made within one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 mm and the other is greater than 0.45 mm. For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any one combination of technique factors shall be within ±1 of the mean value for all measurements at these technique factors.

D. Field limitation and alignment for mobile, portable, and stationary general purpose x-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems shall meet the following requirements:

1. Variable x-ray field limitation. A means for stepless adjustment of the size of the x-ray field shall be provided. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm.

2. Visual definition.

a. Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

b. When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 10 foot-candles at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.

c. The edge of the light field at 100 cm or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance three mm from the edge of the light field toward the center of the field, and I2 is the illuminance three mm from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of one mm.

E. Field indication and alignment on stationary general purpose x-ray equipment. Except when spot-film devices are in service, stationary general purpose x-ray systems shall meet the following requirements in addition to those prescribed in subsection D of this section:

1. Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2.0% of the SID and to indicate the SID to within 2.0%;

2. The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;

3. Indication of field size dimensions and SIDs shall be specified in centimeters or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor that correspond to those indicated by the beam-limiting device to within 2.0% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and

4. Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of 100, 150, and 200 cm or 36, 40, 48, and 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 cm or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.

F. Field limitation on radiographic x-ray equipment other than general purpose radiographic systems.

1. Equipment for use with intraoral image receptors. Radiographic equipment designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

a. If the minimum source-to-skin distance (SSD) is 18 cm or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven cm; and

b. If the minimum SSD is less than 18 cm, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than six cm.

For dental intraoral uses, an open ended shielded positioning device shall be used.

2. X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor and to align the center of the x-ray field with the center of image receptor to within 2.0% of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.

3. Systems designed for mammography.

a. Radiographic systems designed only for mammography and general purpose radiography systems, when special attachments for mammography are in service, manufactured on or after November 1, 1977, and before September 30, 1999, shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. When the beam-limiting device and image receptor support device are designed to be used to immobilize the breast during a mammographic procedure and the SID may vary, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.

b. Mammographic beam-limiting devices manufactured on or after September 30, 1999, shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. For systems that allow changes in SID, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.

c. Each image receptor support device manufactured on or after November 1, 1977, intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.

4. Other x-ray systems. Radiographic systems not specifically covered in subsections D, E, and H of this section, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2.0% of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the x-ray field with the center of the image receptor to within 2.0% of the SID, or means shall be provided to both size and alignment the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:

a. A system that performs in accordance with subsections D and E of this section; or when alignment means are also provided, may be met with either;

b. An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

c. A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

G. Positive beam limitation (PBL). The requirements of this subsection shall apply to radiographic systems that contain PBL.

1. Field size. When a PBL system is provided, it shall prevent x-ray production when:

a. Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3.0% of the SID; or

b. The sum of the length and width differences stated in subdivision 1 a of this subsection without regard to sign exceeds 4.0% of the SID.

c. The beam-limiting device is at an SID for which PBL is not designed for sizing.

2. Conditions for PBL. When provided, the PBL system shall function as described in subdivision 1 of this subsection whenever all the following conditions are met:

a. The image receptor is inserted into a permanently mounted cassette holder;

b. The image receptor length and width are less than 50 cm;

c. The x-ray beam axis is within ±3 degrees of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam axis is within ±3 degrees of horizontal and the SID is 90 cm to 205 cm inclusive;

d. The x-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and

e. Neither tomographic nor stereoscopic radiography is being performed.

3. Measuring compliance. Compliance with the requirements of subdivision 1 of this subsection shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of subdivision 2 of this subsection are met. Compliance shall be determined no sooner than five seconds after insertion of the image receptor.

4. Operator initiated undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm. Return to PBL function as described in subdivision 1 of this subsection shall occur automatically upon any change of image receptor size or SID.

5. Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:

"For X-Ray Field Limitation System Failure"

The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.

H. Field limitation and alignment for spot-film devices. The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:

1. Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor that has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.

2. Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4.0% of the SID. On spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

3. The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2.0% of the SID.

4. Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:

a. For spot-film devices used on fixed-SID fluoroscopic systems that are not required to and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or

b. For spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.

5. A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

"For X-ray Field Limitation System Failure"

I. Source-skin distance.

1. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-skin distance to not less than:

a. 18 cm if operable above 50 kVp; or

b. 10 cm if not operable above 50 kVp.

2. Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than 30 cm.

J. Beam-on indicators. The x-ray control shall provide visual indication whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

K. Reserved.

L. Radiation from capacitor energy storage equipment. Radiation emitted from the x-ray tube shall not exceed:

1. An air kerma of 0.26 microGy (0.03 mR exposure) in one minute at five cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of 100 square cm, with no linear dimensions greater than 20 cm: and

2. An air kerma of 0.88 mGy (100 mR exposure) in one hour at 100 cm from the x-ray source, with beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in one hour (duty cycle). The measurements shall be averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

M. Primary protective barrier for mammography x-ray systems.

1. For x-ray systems manufactured after September 5, 1978, and before September 30, 1999, which are designed only for mammography, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the image receptor supporting device does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.

2. For mammographic x-ray systems manufactured on or after September 30, 1999:

a. At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge.

b. The x-ray system shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in subdivision 2 a of this subdivision.

c. The transmission of the useful beam through the primary protective barrier shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the primary protective barrier does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.

3. Compliance with the requirements of subdivisions 1 and 2 c of this subsection for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the primary protective barrier along the chest wall side.

N. Reserved.

O. Beam limitation, except mammographic systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam-limiting device meeting manufacturer's specifications and the requirements of subsection G of this section have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge).

P. Radiation exposure control.

1. Exposure initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.

2. Exposure indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

3. Operator protection, except veterinary systems.

a. Stationary systems. Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator may remain in that protected area during the entire exposure. For dental intraoral systems installed prior to September 20, 2006, if the x-ray control is not permanently mounted behind a protected barrier, then dosimetry is required by all operators of the system.

b. Mobile and portable systems. Mobile and portable x-ray systems that are:

(1) Used continuously for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of subdivision 3 a of this subsection;

(2) Used for less than one week at the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during the exposure.

4. Operator protection for veterinary systems. All stationary, mobile or portable x-ray systems used for veterinary work shall be provided with either a two meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during exposures.

Q. Tube stands for portable x-ray systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.

R. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all x-ray machines covered by this section in order to assure compliance with the regulations, except that bone densitometers, hand-held units, and x-ray machines other than head CT or cone beam units used in the practice of podiatry, dentistry, or veterinary medicine shall be surveyed every three years. The surveys shall be performed by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection.

12VAC5-481-1630

12VAC5-481-1630. Intraoral dental radiographic systems. (Repealed.)

In addition to the provisions of 12VAC5-481-1590 and 12VAC5-481-1600, the requirements of 12VAC5-481-1630 apply to X-ray equipment and associated facilities used for dental radiography. Requirements for extraoral dental radiographic systems are covered in 12VAC5-481-1620. Only systems meeting the requirements of this section shall be used.

A. Source-to-skin distance (SSD). X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit SSD, to not less than:

1. 18 centimeters if operable above 50 kVp; or

2. 10 centimeters if operable at 50 kVp only.

B. Beam limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the X-ray beam such that the beam at the minimum SSD shall be containable in a circle having a diameter of no more than seven centimeters.

C. Radiation exposure control.

1. Exposure initiation.

a. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action; and

b. It shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.

2. Exposure indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

3. Exposure termination.

a. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

b. An X-ray exposure control shall be incorporated into each X-ray system such that an exposure can be terminated by the operator at any time, except for exposures of two seconds or less.

c. Termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."

4. Exposure duration (timer) linearity. For systems having independent selection of exposure time settings, the average ratios (Xi) of exposure to the indicated timer setting, in units of C kg-1 s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:

(X1-X2) 0.1 (X1+X2)

where X1 and X2 are the average values.

5. Exposure control location and operator protection.

a. After September 20, 2006, stationary X-ray systems shall be required to have the X-ray exposure control permanently mounted behind a protected barrier, so that the operator can remain behind that protected barrier during the entire exposure. Where it is impractical to stand behind a protected barrier, the X-ray exposure shall be permanently mounted at least 2.7 meters (9 feet) from the tube housing assembly while making exposures. If an X-ray machine was installed prior to September 20, 2006, and if the X-ray exposure control is not permanently mounted behind a protected barrier, so that the operator can remain behind that protected barrier during the entire exposure, then dosimetry shall be required by all operators of the X-ray system.

b. Mobile and portable X-ray systems that are:

(1) Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of subdivision 5 of this subsection;

(2) Used for less than one week in the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection, or means shall be provided to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly while making exposures.

D. Reproducibility for Exposure and Time. When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures and times shall be no greater than 0.10, for any specific combination of selected technique factors.

E. mA/mAs linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed X-ray tube potential within the range of 40% to 100% of the maximum rated.

1. Equipment having independent selection of X-ray tube current (mA). The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum:

X1-X2 < 0.10 (X1+X2)

where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of two where the tube current selection is continuous.

2. Equipment having a combined X-ray tube current-exposure time product (mAs) selector, but not a separate tube current (mA) selector. The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum:

X1-X2 < 0.10 (X1+X2)

where X1 and X2 are the average values obtained at any two mAs selector settings, or at two settings differing by no more than a factor of two where the mAs selector provides continuous selection.

3. Measuring compliance. Determination of compliance shall be based on four exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the X-ray tube manufacturer.

F. Accuracy. Deviation of technique factors from indicated values for kVp and exposure time (if time is independently selectable) shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications the deviation shall not exceed 10% of the indicated value for kVp and 10% for time.

G. kVp limitations. Dental X-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.

H. Administrative controls.

1. Patient and film holding devices shall be used when the techniques permit.

2. The tube housing and the PID shall not be hand held during an exposure.

3. The X-ray system shall be operated in such a manner that the useful beam at the patient's skin does not exceed the requirements of subsection B of this section.

4. Dental fluoroscopy without image intensification shall not be used.

I. Radiation safety and equipment performance surveys shall be performed every three years on all dental X-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.

12VAC5-481-1631

12VAC5-481-1631. Intraoral dental radiographic equipment.

In addition to the applicable provisions of 12VAC5-481-1591, 12VAC5-481-1601, and 12VAC5-481-1621, the requirements of this section apply to x-ray equipment and associated facilities used for dental intraoral radiography. Requirements for extraoral dental radiographic systems are in 12VAC5-481-1621.

1. Radiation exposure control. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.

2. Exposure control location and operator protection.

a. Stationary x-ray systems shall be required to have the x-ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure; and

b. Mobile and portable x-ray systems that are:

(1) Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of subdivision 1 of this section.

(2) Used for less than one week in the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection, or means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly while making exposures.

3. kVp limitations. Dental x-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.

4. Administrative controls.

a. Patient and film holding devices shall be used when the techniques permit.

b. The tube housing and the PID for a permanently mounted intraoral dental system shall not be hand-held during an exposure.

c. Dental fluoroscopy without image intensification shall not be used.

12VAC5-481-1640

12VAC5-481-1640. Computed tomography X-ray systems. (Repealed.)

A. Reserved.

B. Requirements for equipment.

1. Termination of exposure.

a. Means shall be provided to terminate the X-ray exposure automatically by either de-energizing the X-ray source or shuttering the X-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function.

b. A visible signal shall indicate when the X-ray exposure has been terminated through the means required by subdivision 1 a of this subsection.

c. The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under CT X-ray system control, of greater than one-half second duration.

2. Tomographic plane indication and alignment.

a. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

b. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

c. If a device using a light source is used to satisfy the requirements of subdivisions 2 a or b of this subsection, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

3. Beam-on and shutter status indicators and control switches.

a. The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.

b. Each emergency button or switch shall be clearly labeled as to its function.

4. Indication of CT conditions of operation. The CT X-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

5. Extraneous radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by subdivision 3 of 12VAC5-481-1600.

6. Maximum surface CTDI identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

7. Additional requirements applicable to CT X-ray Systems containing a gantry manufactured after September 3, 1985.

a. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five millimeters.

b. If the X-ray production period is less than one-half second, the indication of X-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

c. The deviation of indicated scan increment versus actual increment shall not exceed plus or minus one millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

d. Premature termination of the X-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.

C. Facility design requirements.

1. Aural communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

2. Viewing systems.

a. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

b. When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.

D. Surveys, calibrations, spot checks, and operating procedures.

1. Surveys.

a. All CT X-ray systems installed after September 20, 2006, and those systems not previously surveyed shall have a survey made by, or under the direct supervision of a private inspector who is physically present at the facility during the inspection. In addition, such surveys shall be done at least annually or after any change in the facility or equipment that might cause a significant increase in radiation hazard, whichever occurs first.

b. The registrant shall obtain a written report of the survey from the private inspector, and a copy of the report shall be sent to the agency within 60 days of the date of the survey.

2. Radiation calibrations.

a. The calibration of the radiation output of the CT X-ray system shall be performed by, or under the direction of, a private inspector who is physically present at the facility during such calibration.

b. The calibration of a CT X-ray system shall be performed at intervals specified by a private inspector and after any change or replacement of components that, in the opinion of the private inspector, could cause a change in the radiation output.

c. The calibration of the radiation output of a CT X-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two years.

d. CT dosimetry phantom(s) shall be used in determining the radiation output of a CT X-ray system. Such phantom(s) shall meet the following specifications and conditions of use:

(1) CT dosimetry phantom(s) shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter. The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing CT X-ray systems designed to image any section of the body and 16.0 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode;

(2) CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

(3) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom;

(4) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

e. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

f. Calibration shall meet the following requirements:

(1) The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

(2) The CTDI along the two axes specified in subdivision 2 d (2) of this subsection shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant;

(3) The spot checks specified in subdivision 3 of this subsection shall be made.

g. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.

3. Spot checks.

a. The spot-check procedures shall be in writing and shall have been developed by a private inspector.

b. The spot-check procedures shall incorporate the use of a CT dosimetry phantom that has a capability of providing an indication of contrast scale, noise, nominal tomographic section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.

c. All spot checks shall be included in the calibration required by subdivision 2 of this subsection and at time intervals and under system conditions specified by a private inspector.

d. Spot checks shall include acquisition of images obtained with the CT dosimetry phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations required by subdivision 2 of this subsection. The images shall be retained, until a new calibration is performed, in two forms as follows:

(1) Photographic copies of the images obtained from the image display device; and

(2) Images stored in digital form on a storage medium compatible with the CT X-ray system.

e. Written records of the spot checks performed shall be maintained for inspection by the agency.

4. Operating procedures.

a. The CT X-ray system shall not be operated except by an individual who has been specifically trained in its operation.

b. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:

(1) Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

(2) Instructions on the use of the CT dosimetry phantom(s) including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;

(3) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and

(4) A current technique chart available at the control panel that specifies for each routine examination the CT conditions of operation and the number of scans per examination.

c. If the calibration or spot check of the CT X-ray system identifies that a system operating parameter has exceeded a tolerance established by the private inspector, use of the CT X-ray system on patients shall be limited to those uses permitted by established written instructions of the private inspector.

12VAC5-481-1641

12VAC5-481-1641. Computed tomography equipment.

A. Reserved.

B. Requirements for equipment.

1. Termination of exposure.

a. Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function.

b. A visible signal shall indicate when the x-ray exposure has been terminated through the means required by subdivision 1 a of this subsection.

c. The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration.

2. Tomographic plane indication and alignment.

a. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

b. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

c. If a device using a light source is used to satisfy the requirements of subdivision 2 a or b of this subsection, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

3. Beam-on and shutter status indicators and control switches.

a. The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

b. Each emergency button or switch shall be clearly labeled as to its function.

4. Indication of CT conditions of operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

5. Extraneous radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by subdivision 3 of 12VAC5-481-1601.

6. Maximum surface CTDI identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

7. Additional requirements applicable to CT x-ray systems containing a gantry manufactured after September 3, 1985.

a. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five mm.

b. If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

c. The deviation of indicated scan increment versus actual increment shall not exceed one millimeter with any mass from 0 to 100 kg resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

d. Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.

C. Facility design requirements.

1. Aural communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

2. Viewing systems.

a. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

b. When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.

D. Surveys, calibrations, spot checks, and operating procedures.

1. Surveys.

a. All CT x-ray systems installed after September 19, 2006, and those systems not previously surveyed shall have a survey made by, or under the direction of, a qualified medical physicist.  In addition, such surveys shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard.

b. The registrant shall obtain a written report of the survey from the qualified medical physicist, and a copy of the report shall be made available to the agency upon request.

2. Radiation calibrations.

a. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified medical physicist who is physically present at the facility during such calibration.

b. The calibration of a CT x-ray system shall be performed (i) after initial installation and before use on human patients, (ii) annually or at intervals specified by a qualified medical physicist, and (iii) after any change or replacement of components that in the opinion of the qualified medical physicist could cause a change in the radiation output.

c. The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two years.

d. CT dosimetry phantom shall be used in determining the radiation output of a CT x-ray system. Such phantom shall meet the following specifications and conditions of use:

(1) CT dosimetry phantom shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic cm. The phantom shall be at least 14 cm in length and shall have diameters of 32.0 cm for testing CT x-ray systems designed to image any section of the body and 16.0 cm for systems designed to image the head or for whole body scanners operated in the head scanning mode;

(2) CT dosimetry phantom shall provide means for the placement of a dosimeter along the axis of rotation and along a line parallel to the axis of rotation 1.0 cm from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

(3) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and

(4) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

e. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

f. Calibration shall meet the following requirements:

(1) The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

(2) The CTDI along the two axes specified in subdivision 2 d (2) of this subsection shall be measured. For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 cm from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified.  The CT conditions of operation shall correspond to typical values used by the registrant; and

(3) The spot checks specified in subdivision 3 of this subsection shall be made.

g. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.

3. Spot checks.

a. The spot-check procedures shall be in writing and shall have been developed by a qualified medical physicist.

b. The spot-check procedures shall incorporate the use of a CT dosimetry phantom that has a capability of (i) providing an indication of contrast scale, noise, nominal tomographic section thickness, and the resolution capability of the system for low and high contrast objects; and (ii) measuring the mean CTN for water or other reference material.

c. All spot checks shall be included in the calibration required by subdivision 2 of this subsection and at time intervals and under system conditions specified by a qualified medical physicist.

d. Spot checks shall include acquisition of images obtained with the CT dosimetry phantom or phantoms using the same processing mode and CT conditions of operation as are used to perform calibrations required by subdivision 2 of this subsection.

e. The results of each spot check shall be maintained for two years.

4. Operating procedures.

a. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.

b. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:

(1) Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

(2) Instructions on the use of the CT dosimetry phantoms including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;

(3) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and

(4) A current technique chart available at the control panel that specifies for each routine examination the CT conditions of operation and the number of scans per examination.

c. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified medical physicist, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified medical physicist.

12VAC5-481-1650

12VAC5-481-1650. Mammography. (Repealed.)

A. Equipment standards. Only X-ray systems meeting the following standards shall be used.

1. System design. The X-ray system shall be specifically designed for mammography.

2. Image receptor. The image receptor systems and their individual components shall be specifically designed for or appropriate for mammography.

3. kVp/target/filter. The X-ray system shall have the capability of providing kVp/target/filter combinations compatible with the selected image receptor system.

4. Beam quality.

a. When used with screen-film image receptors, and when the contribution to filtration made by the compression device is included, the useful beam shall have a half-value layer (HVL):

(1) Between the values of: ((measured kVp)/100) and ((measured kVp)/100 + 0.1) millimeters aluminum for molybdenum targets;

(2) At least the value of ((measured kVp)/100) millimeters aluminum for rhodium alloy targets.

b. For xeroradiography, the HVL of the useful beam with the compression device in place shall be at least 1.0 and not greater than 1.6 mm aluminum, measured at 49 kVp with a tungsten target tube.

5. Resolution. The combination of focal spot size, source-to-image receptor distance and magnification shall result in a resolution of at least 12 line pairs per millimeter (cycles/mm) measured when a resolution pattern is positioned 4.2 cm above all breast supports and when the resolution pattern is either perpendicular to or parallel with the chest wall edge of the image receptor support. The measurement shall be made with the kVp in the range of 25-30 and the mA shall be the highest available for the focal spot size selected. The resolution shall be at least 11 line pairs when a high-contrast resolution bar test pattern is orientated with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line pairs/mm when the bars are parallel to that axis. The bar pattern must be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within one cm of the chest wall edge of the image receptor. When more than one target material is provided, the measurement must be made using the appropriate focal spot for each target material.

6. Compression.

a. The X-ray system shall be capable of compressing the breast with a force of at least 25 pounds and shall be capable of maintaining this compression for at least three minutes.

b. The chest wall edge of the compression paddle shall extend beyond the chest wall edge of the image receptor by no more than 2.0% of the Source-to-Image Receptor Distance with the compression paddle placed 4.2 cm above the breast support device. With the compression paddle in this position, the chest wall edge of the compression paddle shall not be visible in the acquired image.

7. System capabilities. A mammographic X-ray system utilizing screen-film image receptors shall have:

a. The capability of using anti-scatter grids that are:

(1) Integral to the X-ray system;

(2) Available for all image receptor sizes used;

b. The capability of automatic exposure control, for systems installed after September 20, 2006; and

c. The capability of displaying post-exposure mAs after an exposure made using an automatic exposure control device, for systems installed after September 20, 2006.

8. Milliampere-second read-out accuracy. For those mammographic X-ray systems equipped with automatic exposure control and post-exposure mAs read-out, the indicated mAs read-out shall be within 10% of the actual mAs delivered.

9. Transmission. For X-ray systems manufactured after September 5, 1978, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the exposure five centimeters from any accessible surface beyond the plane of the image receptor supporting device does not exceed 25.8 nC/kg (0.1 milliroentgen) for each activation of the tube. Exposure shall be measured with the system operated at the minimum SID for which it is designed. Compliance shall be determined at the maximum rated peak tube potential for the system and at the maximum rated product of tube current and exposure time (mAs) for that peak tube potential. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

10. Collimation.

a. All systems shall have beam-limiting devices that allow the entire chest wall edge of the X-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the X-ray field does not extend beyond any edge of the image receptor by more than 2.0% of the SID.

b. Means for visually defining the perimeter of the X-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam.

11. Accuracy of kVp. Deviation of actual kVp from the indicated kVp shall not exceed the limits specified by the manufacturer of the X-ray system, or, the actual kVp shall be within plus or minus 2 kVp of the indicated kVp, whichever limit is more restrictive.

12. Automatic exposure control performance. In addition to 12VAC5-481-1620 D, mammographic systems in the AEC mode shall be able to maintain constant film density to within an optical density of plus or minus 0.3 of the average optical density over the kVp range used clinically, using phantoms of BR-12 or other breast equivalent material thicknesses of two centimeters to six centimeters. If the facility has established a technique chart that utilizes varying technical factors for different breast thicknesses, those adjustments in technique may be used when performing this test.

13. Radiation output minimum. At 28 kVp, with a focal spot meeting the requirements of subdivision A 5 of this section, the mammographic system shall be capable of sustaining a minimum output rate of 130 %v(508)%E2%vC/kg/sec (500 mR/sec) for at least three seconds. This output shall be measured at a point 4.2 centimeters from the surface of the breast support device when the SID is at its maximum and the effect of compression paddle attenuation is included.

14. Screen-film contact. Cassettes shall not be used for mammography if poor contact of two or more large areas (>1 cm in diameter) or a section longer than 1 cm and >2 mm in width along the chest wall edge can be seen in a 40 mesh test.

15. Image quality. The mammographic X-ray imaging system shall be capable of providing an image of a 0.75 mm fiber, 0.32 mm speck group, and a 0.75 mm mass from the Conference of Radiation Control Program Directors NEXT "92 phantom (or equivalent) on the standard mammographic image receptor system in use at a facility. Mammograms shall not be taken on patients if this minimum is not met. Any fibers, speck groups and masses larger than those specified shall also be imaged.

16. Dose. The mean glandular dose for one craniocaudal view, measured with the phantom referenced in subdivision 15 of this subsection, based on exposure measured at the breast entrance location, and using dose conversion factors specified by the Health Care Financing Administration in their Medicare Mammography Survey Protocols, shall not exceed the following values:

a. 2.0 mGy (200 millirads) for nongrid screen film systems;

b. 3.0 mGy (300 millirads) for screen-film systems with grid.

17. Technique settings. The technique settings used for subdivisions 15 and 16 of this subsection shall be those used by the facility for its clinical images of a 50% adipose, 50% glandular, 4.2 cm compressed breast.

B. Quality assurance.

1. Quality assurance program required. The registrant shall have a written, on-going equipment quality assurance program specific to mammographic imaging, covering all components of the diagnostic X-ray imaging system, to ensure consistently high-quality images with minimum patient exposure. Responsibilities under this requirement include providing qualified individuals who are to:

a. Conduct equipment performance monitoring functions;

b. Analyze the monitoring results to determine if there are problems requiring correction;

c. Carry out or arrange for the necessary corrective actions when results of quality control tests including those specified in subdivision 3 of this subsection indicate the need; and

d. Maintain records for a minimum of two years documenting that actions required under subdivisions 1 a through c of this subsection have been completed.

2. Quality assurance program review. At intervals not to exceed 12 months, the registrant shall:

a. Have the annual quality control tests specified in subdivision 3 of this subsection performed by a qualified individual and obtain the results of those tests, incorporating them into the records specified in subdivision 1 d of this subsection; and

b. Conduct a review of the effectiveness of the quality assurance program required in subdivision 1 of this subsection and maintain a written report of such review. Records of annual reviews shall be maintained for a minimum of two years and shall be available for agency review.

3. Equipment quality control tests. The registrant shall ensure that the following quality control tests are performed when applicable equipment or components are initially installed, or replaced or serviced (if such servicing affects test results), and performed thereafter at least as often as the frequency specified. The private inspector shall determine the corrective action interval.

a. Processor performance by sensitometric means—daily, or day of use, prior to the first patient exposure. For any mammography registrant using film processors at multiple locations, such as a mobile service, each processor shall be subject to this requirement. Corrective action shall be taken when:

(1) Deviations of 0.15 or more in optical density from established operating levels occur for readings of mid-density (MD) and density difference (DD) on the sensitometric control charts;

(2) Base plus fog (B+F) exceeds the established operating level by more than 0.03 in optical density.

b. Resolution—upon tube installation or replacement and every 12 months.

c. Focal spot size—upon tube installation or tube replacement only or at least every 12 months, whichever occurs first.

d. Half-value layer—12 months.

e. kVp accuracy and reproducibility—12 months.

f. Output reproducibility, mA linearity, and mR/mAs—12 months.

g. Automatic exposure control reproducibility and performance (response to kVp and phantom thickness variations)—12 months.

h. Screen-film contact and screen artifact detection—six months.

i. Compression device performance (releases, level of force, etc)—six months.

j. Collimator alignment—12 months.

k. Primary/secondary barrier transmission—upon initial X-ray system installation and significant modification of the system or the facility.

l. Image quality (using a test "phantom," that simulates the composition of the breast and includes simulations of breast structures)—weekly for stationary systems, on each day of use for mobile systems, and upon significant service or modification of any mammographic system.

m. Densitometer accuracy check—every 12 months.

n. Glandular dose—every 12 months.

o. Image quality—every 12 months.

p. Artifacts—every 12 months.

4. Additional quality control requirements. The registrant shall perform the following observations and procedures according to the frequency noted and record the results. Corrections of problems noted shall be made and recorded. Records shall be maintained over the most recent two-year period.

a. Retake Analysis—three months.

b. Viewbox uniformity—six months.

c. Darkroom integrity (safelight condition, light leaks, etc.)—six months.

d. Screen cleaning—weekly.

e. Fixer retention—three months.

C. Additional facility requirements.

1. Masks. Masks shall be provided on the viewboxes to block extraneous light from the viewer's eye when the illuminated surface of the viewbox is larger than the exposed area of the film.

2. Film processing.

a. Film processors utilized for mammography shall be adjusted to and operated at the specifications recommended by the mammographic film manufacturer, or at other settings such that the sensitometric performance is at least equivalent.

b. Clinical films and phantom image quality films shall be processed within 10 hours of exposure.

c. Facilities shall offer to process films before the patient leaves the facility. If the patient chooses not to wait; of there is not developing capabilities, the patient will be notified within two business days if additional films are necessary.

3. Instruments and devices. An image quality phantom, sensitometer, and a calibrated densitometer shall be available to each facility in order to comply with the quality control test frequencies specified in subdivision B 3 of this section.

4. Operator qualifications. The operator of the X-ray machine shall be certified by the American Registry of Radiologic Technologists and shall have had specialized training in mammography meeting the requirements set forth by the FDA under the MQSA of 1992.

5. Physician qualifications. The physician interpreting the mammograms shall be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or Board eligible, or equivalent, and shall have had specialized training in mammography and image interpretation.

6. Physicist qualifications. The person performing evaluation of mammographic system performance in accordance with these regulations shall meet the requirements set forth in 12VAC5-481-340 C.

7. Image retention. Clinical images shall be retained for a minimum of five years or 10 years if no other clinical images are obtained.

8. Retake rate. Corrective action shall be taken if the retake rate exceeds 5.0%. The retake rate shall be calculated as (repeated + rejected films)/ total number of clinical films.

9. Darkroom fog. Darkroom fog levels shall not exceed 0.05 in optical density when sensitized mammographic film of the type used in the facility is exposed to darkroom conditions with safelight on for two minutes. Film shall be sensitized by exposing it to sufficient light from an appropriate intensifying screen or sensitometer so that after processing an optical density of at least 1.0 is achieved.

Facility qualifications. The registrant performing mammography shall be accredited by the American College of Radiology or another agency recognized as a certifying body or have their application pending. The registrant shall also be certified by the FDA or another agency recognized as an accrediting body under the MQSA of 1992 or have a provisional/interim certificate.

D. Additional state requirements.

1. When film developing is not available or the patient chooses not to wait, the patient shall be notified within two business days if another mammogram is necessary. This requirement does not imply or require that a diagnostic opinion be made at the time of the mammogram. The interpreting physician may require that the mammogram be retaken if, in the opinion of the physician, the study is of inadequate quality.

2. Agency inspectors may conduct unannounced inspections during normal hours of business.

12VAC5-481-1651

12VAC5-481-1651. Mammography requirements.

A. Only x-ray systems, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 (Public Law 105-248) and 21 CFR Part 900, shall be used for screening and diagnostic mammography.

B. A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

C. A facility performing mammography shall ensure that the additional mammography activities of processing the x-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

D. The operator of the mammography machine shall be certified by the American Registry of Radiologic Technologists (ARRT) and shall have had specialized training in mammography meeting the requirements set forth by the U.S. Food and Drug Administration under the Mammography Quality Standards Reauthorization Act of 1998.

E. When film developing is not available or the patient chooses not to wait, the patient shall be notified within two business days if another mammogram is necessary. This requirement does not imply or require that a diagnostic opinion be made at the time of the mammogram. The interpreting physician may require that the mammogram be retaken if, in the opinion of the physician, the study is of inadequate quality.

F. Agency inspectors may conduct unannounced inspections during normal business hours.

12VAC5-481-1653

12VAC5-481-1653. Hand-held radiographic unit.

In addition to the applicable provisions found elsewhere in this chapter, the following provisions apply to a hand-held radiographic unit.

1. A hand-held radiograph unit shall be:

a. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.

b. Registered with the agency in accordance with applicable parts of this chapter.

c. Maintained and operated in accordance with the manufacturer's specifications.

2. For all uses:

a. Operators of a hand-held radiographic unit shall be specifically trained to operate such equipment.

b. When operating a hand-held radiographic unit, operators shall wear dosimetry unless otherwise authorized by the agency.

c. A hand-held radiographic unit shall have the backscatter radiation shield in place to protect the operator during operation.

d. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand-held radiograph unit.

e. A hand-held radiographic unit shall not be used in hallways or waiting rooms.

12VAC5-481-1655

12VAC5-481-1655. Bone densitometry.

A. A bone densitometry system shall be:

1. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.

2. Registered with the agency in accordance with applicable parts of this chapter.

3. Maintained and operated in accordance with the manufacturer's specifications.

B. Equipment requirements. A system with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond 2.0% of the SID.

C. Operators of a bone densitometry system shall meet one of the following:

1. Be certified by the American Registry of Radiologic Technologists (ARRT);

2. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a radiologic technologist or a limited radiologic technologist for bone density operation;

3. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or

4. Be in an accredited program for radiologic technology and under the supervision of an individual who meets one of the criteria listed in subdivisions 1, 2, or 3 of this subsection.

D. During the operation of any bone densitometry system:

1. The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.

2. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

E. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision A 3 of this section. These records shall be maintained for inspection by the agency.

F. Bone densitometry on human patients shall be conducted only:

1. Under a prescription of an individual licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or

2. Under a screening program approved by the agency.

12VAC5-481-1657

12VAC5-481-1657. Quality assurance program.

All registrants of diagnostic x-ray imaging equipment may be required by the agency to establish and maintain a quality assurance program consisting of quality control assessments.

12VAC5-481-2110

12VAC5-481-2110. Area requirements.

A. Radiation Levels. The local components of an analytical X-ray x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group that could result in a dose to an individual present therein in excess of the dose limits given in 12VAC5-481-640. For systems utilizing X-ray x-ray tubes, these levels shall be met at any specified tube rating.

B. Surveys.

1. Radiation surveys, as required by 12VAC5-481-750, of all analytical X-ray x-ray systems sufficient to show compliance with 12VAC5-481-2440 A shall be performed:

a. Upon installation of the equipment, and at least once every 12 months five years thereafter;

b. Following any change in the initial arrangement, number, or type of local components in the system;

c. Following any maintenance requiring the disassembly or removal of a local component in the system;

d. During the performance of maintenance and alignment procedures if the procedures require the presence of a primary X-ray x-ray beam when any local component in the system is disassembled or removed;

e. Any time a visual inspection of the local components in the system reveals an abnormal condition; and

f. Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in 12VAC5-481-630.

2. Radiation survey measurements shall not be required if a registrant (or licensee) can demonstrate compliance with subsection A of this section to the satisfaction of the agency.

C. Posting. Each area or room containing analytical X-ray x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION—X-RAY EQUIPMENT" or words having a similar intent in accordance with 12VAC5-481-660.

12VAC5-481-3410

12VAC5-481-3410. Quality management program.

The facility shall implement a quality management program. The facility shall include in the quality management program written notification to the agency within 72 hours of discovery of a reportable event or a misadministration, a recordable event, and recording written directives.