TITLE 13. HOUSING
VA.R. Doc. No. R16-4573; Filed March 30, 2016, 10:19 a.m.
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R16-4659; Filed March 22, 2016, 8:38 a.m.
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R16-4661; Filed March 24, 2016, 9:46 a.m.
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R16-4641; Filed March 24, 2016, 9:28 a.m.
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R16-4660; Filed March 28, 2016, 8:18 a.m.
TITLE 8. EDUCATION
VA.R. Doc. No. R11-2611; Filed March 24, 2016, 9:20 a.m.
TITLE 8. EDUCATION
VA.R. Doc. No. R16-4393; Filed March 29, 2016, 12:00 p.m.
TITLE 12. HEALTH
Title of Regulation: 12VAC5-481. Virginia Radiation
Protection Regulations (amending 12VAC5-481-10, 12VAC5-481-3390
through 12VAC5-481-3450; adding 12VAC5-481-3451, 12VAC5-481-3452,
12VAC5-481-3453).
Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code
of Virginia.
Public Hearing Information: No public hearings are
scheduled.
Public Comment Deadline: May 18, 2016.
Effective Date: June 5, 2016.
Agency Contact: Steve Harrison, Director, Office of
Radiological Health, Department of Health, 109 Governor Street, Richmond, VA
23219, telephone (804) 864-8151, FAX (804) 864-8155, or email
steve.harrison@vdh.virginia.gov.
Basis: Section 32.1-229 of the Code of Virginia
authorizes the State Board of Health to require the licensure and inspection of
radioactive materials facilities and mandates inspections of mammography
facilities. Section 32.1-229.1 of the Code of Virginia requires the State Board
of Health to promulgate regulations for the registration, inspection, and
certification of x-ray machines.
Purpose: The Virginia Department of Health (VDH), Office
of Radiological Health (ORH) proposes to amend 12VAC5-481, Virginia Radiation
Protection Regulations, to reflect changes in and new x-ray modalities
pertaining to the medical field, amend existing and add new definitions, and
update the regulations to meet the current Virginia Register Form, Style, and
Procedure Manual.
Rationale for Using Fast-Track Rulemaking Process:
Practitioners have requested that regulations providing for the use of
therapeutic radiation machines be instituted in the Commonwealth in order to
remain up to date with regard to current practices. The regulated community has
requested that regulations be put into place for the proper operation of
therapeutic and electronic brachytherapy equipment. This initiative was
discussed and endorsed at the November 2014 Radiation Advisory Board meeting.
Accordingly, ORH does not view this initiative as being controversial in
nature.
Substance: The Conference of Radiation Control Program
Directors (CRCPD) develops Suggested State Regulations (SSRs) upon which an
individual state may base its regulations. The x-ray regulations were based
upon the SSRs when adopted in 2006; this amendment will ensure that Virginia's
regulations are brought up to date by incorporating the most recent CRCPD SSRs
in totality. This action adds or amends provisions concerning radiation therapy
machines, including electronic brachytherapy, as follows:
1. Adds new terms and definitions in 12VAC5-481-10, including
conventional simulator, electronic brachytherapy, electronic brachytherapy
device, electronic brachytherapy source, intensity modulated radiation therapy
(IMRT), mobile electronic brachytherapy service, qualified inspector, qualified
medical physicist, radiation therapy system, target-skin distance (TSD), and
virtual simulator.
2. Amends definitions in 12VAC5-481-10, including beam-limiting
device, leakage radiation, light field, prescribed dose, and therapeutic
radiation machine.
3. Amends the following sections in Part XV, Therapeutic
Radiation Machines: 12VAC5-481-3390, General administrative requirements for
facilities using therapeutic radiation machines; 12VAC5-481-3400, General
technical requirements for facilities using therapeutic radiation machines;
12VAC5-481-3410, Quality management program; 12VAC5-481-3420, Therapeutic
radiation machines of less than 500 kV; 12VAC5-481-3430, Therapeutic radiation
machines - photon therapy systems (500 kV and above) and electron therapy
systems (500 kV and above), and electron therapy systems (500kv and above); and
12VAC5-481-3450, Shielding and safety design requirements.
4. Adds the following new sections to Part XV, Therapeutic
Radiation Machines: 12VAC5-481-3451, Quality assurance for radiation therapy
simulation systems; 12VAC5-481-3452, Electronic brachytherapy; and
12VAC5-481-3453, Other use of electronically-produced radiation to deliver
therapeutic radiation dosage.
Issues: The advantage of this action is that health care
providers regulated by VDH will operate under clear worker and machine
performance standards. Another advantage for health care professionals and
patients is that regulations governing the application of radiation will meet
nationally recognized performance standards, which will promote quality of
care. There are no disadvantages to the public in promulgating the proposed
regulation.
The advantage of the proposed regulation to the agency is that
the proper regulation of therapeutic radiation producing machines will now be
addressed. There are no disadvantages to the agency in promulgating the
proposed regulation. There are no disadvantages to the public or the
Commonwealth as a result of this initiative.
Department of Planning and
Budget's Economic Impact Analysis:
Summary of the Proposed Amendments to Regulation: The State
Health Commissioner proposes to amend the Virginia Radiation Protection
Regulations to 1) add new definitions, amend existing definitions and update
other sections of this regulation so that it accurately reflects current
practice for therapeutic radiation machines and 2) update the regulation so
that it conforms to the current Virginia Register Form, Style and Procedure
Manual.
Result of Analysis. Benefits likely outweigh costs for all
proposed regulatory changes.
Estimated Economic Impact. The Commissioner proposes to add
eleven new definitions and amend a further five to account for new therapeutic
radiation machine techniques and procedures. For instance, the Commissioner
proposes to add a definition for "radiation therapy systems" and
amend the definition of "therapeutic radiation machine." The
Commissioner also proposes to add language to the regulatory text to clarify
current procedures and requirements for the regulated community. Some of these
changes will, for instance, replace general language that requires facilities
that own machines covered by this regulation to have a quality management
program with specific language that lays out exactly what is currently required
of such a program.
All of these amendments, as well as the amendments that bring
regulatory language into conformity with the state's regulatory style manual,
are clarifying rather than substantive. No affected entity is likely to incur
costs on account of any of these changes. To the extent that this regulation was
out of date and out of sync with current radiation machine practices and
terminology, these changes will benefit readers who will likely find the
regulation easier to understand and comply with.
Businesses and Entities Affected. Virginia Department of Health
staff reports that this x-ray program currently registers approximately 21,464
x-ray machines. Of these 21,464, approximately 90 are therapeutic radiation
machines. Staff further reports that approximately 1,500 registrants meet the
criteria for small business.
Localities Particularly Affected. No locality will be
particularly affected by this regulatory change.
Projected Impact on Employment. These regulatory changes are
unlikely to have any effect on employment in the Commonwealth.
Effects on the Use and Value of Private Property. These
proposed regulatory changes are unlikely to affect the use or value of private
property in the Commonwealth.
Real Estate Development Costs. These proposed regulatory
changes are unlikely to affect real estate development costs in the
Commonwealth.
Small Businesses:
Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia,
small business is defined as "a business entity, including its affiliates,
that (i) is independently owned and operated and (ii) employs fewer than 500
full-time employees or has gross annual sales of less than $6 million."
Costs and Other Effects. Small businesses are unlikely to incur
any costs on account of these proposed regulatory changes.
Alternative Method that Minimizes Adverse Impact. Small
businesses are unlikely to incur any costs on account of these proposed
regulatory changes.
Adverse Impacts:
Businesses. Businesses are unlikely to incur any costs on
account of these proposed regulatory changes.
Localities. Localities in the Commonwealth are unlikely to see
any adverse impacts on account of this proposed regulatory change.
Other Entities. No entities are likely to incur any costs on
account of these regulatory changes.
Agency's Response to Economic Impact Analysis: The
Virginia Department of Health concurs with the economic impact analysis
submitted by the Department of Planning and Budget.
Summary:
To reflect changes in and new x-ray modalities for the
medical field, including therapeutic and electonic brachytherapy equipment,
this action (i) amends and adds defined terms and (ii) updates the regulatory
text to clarify current procedures and requirements.
Part I
General Provisions
12VAC5-481-10. Definitions.
The following words and terms as used in this chapter shall
have the following meanings unless the context clearly indicates otherwise:
"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.
"Access control" means a system for allowing only
approved individuals to have unescorted access to the security zone and for
ensuring that all other individuals are subject to escorted access.
"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).
"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.
"Aggregated" means accessible by the breach of a
single physical barrier that would allow access to radioactive material in any
form, including any devices that contain the radioactive material, when the
total activity equals or exceeds a Category 2 quantity of radioactive material
as listed in 12VAC5-481-451.
"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" or "K" means 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 equipment" means equipment used for
x-ray diffraction or fluorescence analysis.
"Analytical 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" 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.
"Approved individual" means an individual whom the
licensee has determined to be trustworthy and reliable for unescorted access in
accordance with 12VAC5-481-451 and has completed the training required in 12VAC5-481-451.
"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" 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" 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 system or subsystem. The term includes the owner of an x-ray system or
his employee or agent who assembles components into an 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" or "AEC"
means a device that automatically controls one or more technique factors in
order to obtain, at a preselected location(s) location, a
required quantity of radiation (includes devices such as phototimers and ion
chambers).
"Background investigation" means the investigation
conducted by a licensee or applicant to support the determination of
trustworthiness and reliability.
"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 fields.
"Beam-limiting device" means a device that provides
a means to restrict the dimensions of the x-ray field or useful beam.
"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" 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 fluoroscope" means an x-ray system in which
the image receptor and 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 system" means an x-ray system with
the 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 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 systems designed primarily for
the inspection of carry-on baggage at airline, railroad, and bus terminals, and
in similar facilities. An x-ray tube used within a shielded part of a building,
or x-ray equipment that may temporarily or occasionally incorporate portable
shielding, is not considered a cabinet 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.
"Category 1 quantities of radioactive material" or
"Category 1" means a quantity of radioactive material meeting or
exceeding the Category 1 threshold in Table 1 of 12VAC5-481-451. This is
determined by calculating the ratio of the total activity of each radionuclide
to the Category 1 threshold for that radionuclide and adding the ratios
together. If the sum is equal to or exceeds 1, the quantity would be considered
a Category 1 quantity. Category 1 quantities of radioactive material do not
include the radioactive material contained in any fuel assembly, subassembly,
fuel rod, or fuel pellet.
"Category 2 quantities of radioactive material" or
"Category 2" means a quantity of radioactive material meeting or
exceeding the Category 2 threshold but less than the Category 1 threshold in
Table 1 of 12VAC5-481-451. This is determined by calculating the ratio of the
total activity of each radionuclide to the Category 2 threshold for that
radionuclide and adding the ratios together. If the sum is equal to or exceeds
1, the quantity would be considered a Category 2 quantity. Category 2
quantities of radioactive material do not include the radioactive material contained
in any fuel assembly, subassembly, fuel rod, or fuel pellet.
"Certifiable cabinet x-ray system" means an
existing uncertified 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" 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 system" means an 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 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.
"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.
"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" or "C" means
the ratio of the standard deviation to the mean value of a population of
observations. It is estimated using the following equation:
where:
s = Standard deviation of the observed values;
X¯ = 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" 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" 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
= S (wT HT,50)).
"Computed tomography" means the production of a
tomogram by the acquisition and computer processing of 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:
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" 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:
where:
µx = Linear
attenuation coefficient of the material of interest;
µw = Linear attenuation coefficient
of water;
= of the material of interest;
= of water.
"Control 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
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.
"Conventional simulator" means any x-ray system
designed to reproduce the geometric conditions of the radiation therapy
equipment.
"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" 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 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" means the number used to represent the
x-ray attenuation associated with each elemental area of the CT image.
where:
k = A constant, a normal value of 1,000 when the
Hounsfield scale of CTN is used;
µx =
Linear attenuation coefficient of the material of interest;
µw =
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.
"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" 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 §§ 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 § 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" 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" 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 system" means an x-ray system
designed for irradiation of any part of the human or animal body for the
purpose of diagnosis or visualization.
"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 and 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.
"Diversion" means the unauthorized movement of
radioactive material subject to 12VAC5-481-451 to a location different from the
material's authorized destination inside or outside of the site at which the
material is used or stored.
"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" 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" 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" 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 = S wTHT).
"Electronic brachytherapy" means a method of
radiation therapy where an electrically generated source of ionizing radiation
is placed in or near the tumor or target tissue to deliver therapeutic
radiation dosage.
"Electronic brachytherapy device" means the
system used to produce and deliver therapeutic radiation including the x-ray
tube, the control mechanism, the cooling system, and the power source.
"Electronic brachytherapy source" means the
x-ray tube component used in an electronic brachytherapy device.
"Elemental area" means the smallest area within a
tomogram for which the 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" 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 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").
"Escorted access" means accompaniment while in a
security zone by an approved individual who maintains continuous direct visual
surveillance at all times over an individual who is not approved for unescorted
access.
"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 or used.
"Fail-safe characteristics" means 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 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" 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.
"Fingerprint orders" means the requirements of
12VAC5-481-451 C or orders issued by the U.S. Nuclear Regulatory Commission or
the legally binding requirements issued by agreement states that require
fingerprints and criminal history records checks for individuals with
unescorted access to Category 1 and Category 2 quantities of radioactive
material or safeguards information-modified handling.
"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 photons produce a set of fluoroscopic images or radiographic
images recorded from the fluoroscopic image receptor. It includes the image
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" or "actual" means the area
projected on the anode of the 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 system" means
any radiographic x-ray system that, 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" or "HVL" means the
thickness of a specified material that attenuates 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 B 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 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 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" 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.
"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 pattern into a
corresponding light image of higher intensity.
"Image receptor" means any device, such as a
fluorescent screen, radiographic film, x-ray image intensifier tube,
solid-state detector, or gaseous detector that transforms incident 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 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").
"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.
"Intensity modulated radiation therapy" or
"IMRT" means radiation therapy that uses nonuniform radiation beam
intensities that have been determined by various computer-based optimization
techniques.
"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 beam axis passes 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" 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 or the radiation therapy system 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, (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 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" 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 the 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 illuminated by light, simulating the
radiation field.
"Limits" (See "Dose limits").
"Line-voltage regulation" means the difference
between the no-load and the load line potentials expressed as a percent of the
load line potential 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" means part of an analytical
x-ray system and include areas that are struck by 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.
"Local law-enforcement agency" or "LLEA"
means a public or private organization that has been approved by a federal,
state, or local government to carry firearms and make arrests and is authorized
and has the capability to provide an armed response in the jurisdiction where
the licensed Category 1 or Category 2 quantity of radioactive material is used,
stored, or transported.
"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 material" or "LSA
material" 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 (e.g., 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.
"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" 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 device" means a piece of equipment
containing licensed radioactive materials that is either mounted on wheels or
casters, or otherwise equipped for moving without a need for disassembly or
dismounting, or designed to be hand carried. Mobile devices do not include
stationary equipment installed in a fixed location.
"Mobile electronic brachytherapy service" means
transportation of an electronic brachytherapy device to provide electronic
brachytherapy at an address that is not the address of record.
"Mobile nuclear medicine service" means the
transportation and medical use of radioactive material.
"Mobile 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" 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.
"Movement control center" means an operation center
that is remote from the transport activity and that maintains the position
information on the movement of radioactive material, receives reports of
attempted attacks or thefts, provides a means for reporting these and other
problems to appropriate agencies and can request and coordinate appropriate
aid.
"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 system that obtains 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" 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.
"No-later-than arrival time" means the date and
time that the shipping licensee and receiving licensee have established as the
time at which an investigation will be initiated if the shipment has not
arrived at the receiving facility. The no-later-than arrival times may not be
more than six hours after the estimated arrival time for shipments of Category
2 quantities of radioactive material.
"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:
where:
=
Linear attenuation coefficient of the material of interest.
µw = Linear attenuation coefficient
of water.
s = 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 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 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 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" 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
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 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 equipment" (See "X-ray
equipment").
"Position indicating device" means a device on
dental 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 beam to the size of the selected image
receptor, whereby exposures cannot be made without such adjustment.
Positron emission tomography radionuclide production
facility" or "PET" means a facility operating a cyclotron or
other particle accelerator for the purpose of producing radionuclides that
decay by positron emission.
"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" 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. 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. The prescribed dose is an estimation
from measured data from a specified therapeutic machine using assumptions that
are clinically acceptable for that treatment technique and historically
consistent with the clinical calculations previously used for patients treated
with the same clinical technique; 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 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" 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)
purposes 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 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.
"Qualified inspector" means an individual who is
granted professional privileges based on education and experience to provide
clinical services in diagnostic and therapeutic medical physics.
"Qualified medical physicist" means an
individual qualified in accordance with 12VAC5-481-3390 D.
"Qualitative fit test" 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" 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" 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, 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" 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 system intended for localizing the volume to
be exposed during radiation therapy and confirming the position and size of the
therapeutic irradiation field.
"Radiation therapy system" means a device that
delivers radiation to a specific area of the body where cancer cells or tumors
are located.
"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 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 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" 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 retrievable form of
an image resulting from 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 U.S. 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 or electron 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.
"Reviewing official" means the individual who shall
make the trustworthiness and reliability determination of an individual to
determine whether the individual may have, or continue to have, unescorted
access to the Category 1 or Category 2 quantities of radioactive materials that
are possessed by the licensee.
"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.
"Sabotage" means deliberate damage, with malevolent
intent, to a Category 1 or Category 2 quantity of radioactive material, a
device that contains a Category 1 or Category 2 quantity of radioactive
material, or the components of the security system.
"Safe haven" means a readily recognizable and
readily accessible site at which security is present or from which, in the
event of an emergency, the transport crew can notify and wait for the local
law-enforcement authorities.
"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
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 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 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.
"Secondary dose monitoring system" means a system
which will terminate irradiation in the event of failure of the primary dose
monitoring system.
"Security zone" means any temporary or permanent
area determined and established by the licensee for the physical protection of
Category 1 or Category 2 quantities of radioactive material.
"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 " 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 " 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 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" 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" or "radiation therapy simulation
system" means any 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 system
that obtains 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 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" or "SSD" means the
distance from the source 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 § 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:
"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 or position a radiographic image receptor
between the 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 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 this chapter,
"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," "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" 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 tube or
accelerator onto which a beam of accelerated particles is directed to produce
ionizing radiation or other particles.
"Target-skin distance" or "TSD" means
the distance measured along the beam axis from the center of the front surface
of the x-ray target or electron virtual source, or both, to the surface of the
irradiated object or patient.
"Technologically Enhanced Naturally Occurring
Radioactive Material" 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 kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);
2. For field emission equipment rated for pulsed operation,
peak tube potential in kilovolts (kV), and number of x-ray pulses;
3. For CT equipment designed for pulsed operation, peak tube
potential in kilovolts (kV), scan time in seconds, and either tube current in
milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses
per scan, or the product of tube current, x-ray pulse width, and the number of
x-ray pulses in milliampere-seconds (mAs);
4. For CT equipment not designed for pulsed operation, peak
tube potential in kilovolts (kV), and either tube current in milliamperes (mA)
and scan time in seconds, or the product of tube current and exposure time in
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 kilovolts
(kV), and either tube current in milliamperes (mA) and exposure time in
seconds, or the product of tube current and exposure time in
milliampere-seconds (mAs).
"Telemetric position monitoring system" means a
data transfer system that captures information by either instrumentation,
measuring devices about the location or both, and status of a transport vehicle
or package between the departure and destination locations.
"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 x-ray fluorescence use is performed and where licensed material may be
stored other than those location(s) locations of use authorized
on the license.
"Tenth-value layer" 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.
"Test" means the process of verifying compliance
with an applicable regulation.
"Therapeutic radiation machine" means x-ray or
electron-producing equipment designed and used for external beam radiation
therapy. For the purpose of this chapter, devices used to administer
electronic brachytherapy shall also be considered therapeutic radiation
machines.
"These regulations" mean all parts of this chapter.
"Tight-fitting facepiece" means a respiratory inlet
covering that forms a complete seal with the face.
"Tomogram" means the depiction of the x-ray
attenuation properties of a section through the body.
"Tomographic plane" means that geometric plane that
is identified as corresponding to the output tomogram.
"Tomographic section" means the volume of an object
whose x-ray attenuation properties are imaged in a tomogram.
"Total effective dose equivalent" 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" 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 U.S. Department
of Transportation.
"Transport index" 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) feet)).
"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.
"Trustworthiness and reliability" means
characteristics of an individual considered dependable in judgment, character,
and performance, such that unescorted access to Category 1 or Category 2
quantities of radioactive material by that individual does not constitute an
unreasonable risk to the public health and safety or security. A determination
of trustworthiness and reliability for this purpose is based upon the results
from a background investigation.
"Tube" means an x-ray tube, unless otherwise
specified.
"Tube housing assembly" means the tube housing with
tube installed. It includes high-voltage and/or 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 or related equipment are beneath the surface of the water.
"Unescorted access" means solitary access to an
aggregated Category 1 or Category 2 quantity of radioactive material or the
devices that contain the material.
"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 that passes
through the tube housing port and the aperture of the beam-limiting device when
the exposure switch or timer is activated.
"User seal 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
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 simulator" means a computed tomography
(CT) unit used in conjunction with relevant software that recreates the
treatment machine and that allows import, manipulation, display, and storage of
images from CT or other imaging modalities, or both.
"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 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, that (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 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 " or "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" 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" 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 of this definition, 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 or
terminates the radiation exposure. The x-ray exposure control may include such
associated equipment as timers and back-up timers.
"X-ray equipment" means an x-ray system, subsystem,
or component thereof. Types of x-ray equipment are as follows:
1. "Mobile x-ray equipment" means x-ray equipment
mounted on a permanent base with wheels and/or casters for moving while
completely assembled.
2. "Portable x-ray equipment" means x-ray equipment
designed to be hand-carried.
3. "Stationary x-ray equipment" means 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 AKR is one-fourth of the maximum in the intersection.
"X-ray high-voltage generator" means a device that
transforms electrical energy from the potential supplied by the 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 tube(s) tubes, 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. It includes minimally an x-ray
high-voltage generator, an 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 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,
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 energy.
"Year" means the period of time beginning in
January used to determine compliance with the provisions of this chapter. 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.
12VAC5-481-3390. General administrative requirements for
facilities using therapeutic radiation machines.
A. Administrative controls. The registrant shall be
responsible for directing the operation of the therapeutic radiation machines
that have been registered with the agency and reporting misadministrations
within 10 days. The registrant or the registrant's agent shall ensure that
the requirements of Part XV (12VAC5-481-3380 et seq.) of this chapter are met in
the operation of the therapeutic radiation machine(s) machines.
B. A therapeutic radiation machine that does not meet the
provisions of these regulations this chapter shall not be used
for irradiation of patients.
C. Training for external beam radiation therapy authorized
users. The registrant for any therapeutic radiation machine subject to
12VAC5-481-3420 or 12VAC5-481-3430 shall require the authorized user to be a
physician who:
1. Is certified in:
a. Radiology Radiation oncology or therapeutic
radiology by the American Board of Radiology or radiology (combined
diagnostic and therapeutic radiology program) by the American Board of
Radiology prior to 1976;
b. Radiation oncology by the American Osteopathic Board of
Radiology;
c. Radiology, with specialization in radiotherapy, as a
British "Fellow of the Faculty of Radiology" or "Fellow of the
Royal College of Radiology"; or
d. Therapeutic radiology by the Canadian Royal College of
Physicians and Surgeons;
or
2. Is in the active practice of therapeutic radiology, and has
completed 200 hours of instruction in basic radiation techniques applicable to
the use of an external beam radiation therapy unit, 500 hours of supervised
work experience, and a minimum of three years of supervised clinical experience.
a. To satisfy the requirement for instruction, the classroom
and laboratory training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
ionization radiation; and
(4) Radiation biology.
b. To satisfy the requirement for supervised work experience,
training shall be under the supervision of an authorized user and shall
include:
(1) Review of the full calibration measurements and periodic
quality assurance checks;
(2) Evaluation of prepared treatment plans and calculation of
treatment times and patient treatment settings;
(3) Using administrative controls to prevent miss-administrations
misadministrations;
(4) Implementing emergency procedures to be followed in the
event of the abnormal operation of an external beam radiation therapy unit or
console; and
(5) Checking and using radiation survey meters.
c. To satisfy the requirement for a period of supervised
clinical experience, training shall include one year in a formal training
program approved by the Residency Review Committee for Radiology of the
Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral
Training of the American Osteopathic Association and an additional two years of
clinical experience in therapeutic radiology under the supervision of an
authorized user. The supervised clinical experience shall include:
(1) Examining individuals and reviewing their case histories
to determine their suitability for external beam radiation therapy treatment,
and any limitations or contraindications;
(2) Selecting proper dose and how it is to be administered;
(3) Calculating the external beam radiation therapy doses and
collaborating with the authorized user in the review of patients' progress and
consideration of the need to modify originally prescribed doses and/or or
treatment plans as warranted by patients' reaction to radiation; and
(4) Post-administration follow-up and review of case
histories.
3. Notwithstanding the requirements of subdivisions 1 and 2 of
this subsection, the registrant for any therapeutic radiation machine subject
to 12VAC5-481-3420 may also submit the training of the prospective authorized
user physician for agency review on a case-by-case basis.
4. A physician shall not act as an authorized user for any
therapeutic radiation machine until such time as said physician's training has
been reviewed and approved by the agency.
D. Training for radiation therapy qualified medical
physicist. The registrant for any therapeutic radiation machine subject to
12VAC5-481-3420 and 12VAC5-481-3430 shall require the radiation therapy qualified
medical physicist to: 1. Be be registered with the agency,
under the provisions of Part II (12VAC5-481-260 et seq.) of this chapter, as a
provider of radiation services in the area of calibration and surveys of
external beam radiation therapy units; and 2. Shall meet the
requirements of 12VAC5-481-340 B 2 to:
1. Be certified by the American Board of Radiology in:
a. Therapeutic radiological physics;
b. Roentgen-ray and gamma-ray physics;
c. X-ray and radium physics; or
d. Radiological physics;
2. Be certified by the American Board of Medical Physics in
Radiation Oncology Physics;
3. Be certified by the Canadian College of Medical Physics;
or
4. Hold a master's or doctor's degree in physics, medical
physics, other physical science, engineering, or applied mathematics from an
accredited college or university and have completed one year of full-time
training in medical physics and an additional year of full-time work experience
under the supervision of a qualified medical physicist at a medical
institution. This training and work experience shall be conducted in clinical
radiation facilities that provide high-energy external beam radiation therapy
(photons and electrons with energies greater than or equal to one MV/one MeV).
To meet this requirement, the individual shall have performed the tasks listed
in 12VAC5-481-3400 A, 12VAC5-481-3420 P, 12VAC5-481-3420 Q, 12VAC5-481-3430 T,
and 12VAC5-481-3430 U under the supervision of a qualified medical physicist
during the year of work experience.
E. Qualifications of operators.
1. Individuals who will be operating a therapeutic radiation
machine for medical use shall be American Registry of Radiologic Technologists
(ARRT) Registered Radiation Therapy Technologists. Individuals who are not ARRT
Registered Radiation Therapy Technologists shall submit evidence that they have
satisfactorily completed a radiation therapy technologist training program that
complies with the requirements of the Joint Review Committee on Education in
Radiologic Technology.
2. The names and training of all personnel currently operating
a therapeutic radiation machine shall be kept on file at the facility.
Information on former operators shall be retained for a period of at least two
years beyond the last date they were authorized to operate a therapeutic
radiation machine at that facility.
F. Written safety procedures and rules shall be developed by
a radiation therapy qualified medical physicist and shall be
available in the control area of a therapeutic radiation machine, including any
restrictions required for the safe operation of the particular therapeutic
radiation machine. The operator shall be able to demonstrate familiarity with
these rules.
G. Individuals shall not be exposed to the useful beam except
for medical therapy purposes and unless such exposure has been ordered in writing
by a licensed practitioner of the healing arts who is specifically
identified on the Certificate of Registration therapeutic radiation
machine authorized user. This provision specifically prohibits deliberate
exposure of an individual for training, demonstration or other nonhealing-arts
non-healing-arts purposes.
H. Visiting authorized user. Notwithstanding the provisions
of subsection G of this section, a registrant may permit any physician to act
as a visiting authorized user under the term of the registrant's Certificate of
Registration for up to 60 days per calendar year under the following
conditions:
1. The visiting authorized user has the prior written
permission of the registrant's management and, if the use occurs on behalf of
an institution, the institution's radiation safety committee, where
applicable; and
2. The visiting authorized user meets the requirements
established for an authorized user(s) user in subdivisions
1 and 2 C 1 and C 2 of this subsection section; and
3. The registrant maintains copies of all records specified
by this subsection for five years from the date of the last visit shall
maintain copies of the written permission required in subdivision 1 of this
subsection and documentation that the visiting authorized user met the
requirements of subdivision 2 of this subsection for five years from the date
of the last visit.
I. All individuals associated with the operation of a
therapeutic radiation machine shall be instructed in and shall comply with the
provisions of the registrant's quality management program. In addition to the
requirements of Part XV of this chapter, these individuals are also subject to
the requirements of 12VAC5-481-640, 12VAC5-481-680, and 12VAC5-481-760.
J. Information and maintenance record and associated
information. The registrant shall maintain the following information in a
separate file or package for each therapeutic radiation machine, for inspection
by the agency:
1. Report of acceptance testing;
2. Records of all surveys, calibrations, and periodic quality
assurance checks of the therapeutic radiation machine required by Part XV of
this chapter, as well as the name(s) of person(s) who performed such
activities;
3. Records of maintenance and/or or
modifications performed on the therapeutic radiation machine after September
20, 2006, as well as the name(s) names of person(s) persons
who performed such services;
4. Signature of person authorizing the return of therapeutic
radiation machine to clinical use after service, repair, or upgrade.
K. Records retention. All records required by Part XV of this
chapter shall be retained until disposal is authorized by the agency unless
another retention period is specifically authorized in Part XV of this chapter.
All required records shall be retained in an active file from at least the time
of generation until the next agency inspection. Any required record generated
prior to the last agency inspection may be microfilmed or otherwise archived as
long as a complete copy of said record can be retrieved until such time as the
agency authorizes final disposal.
12VAC5-481-3400. General technical requirements for facilities
using therapeutic radiation machines.
A. Surveys Protection surveys.
1. The registrant shall ensure that radiation protection
surveys of all new facilities, and existing facilities not previously
surveyed are performed with an operable radiation measurement survey instrument
calibrated in accordance with 12VAC5-481-3440. The radiation protection
survey shall be performed by, or under the direction of, a radiation therapy
qualified medical physicist or a private inspector qualified
inspector and shall verify that, with the therapeutic radiation machine in
a "BEAM-ON" condition, with the largest clinically available
treatment field, and with a scattering phantom in the useful beam of
radiation:
a. Radiation levels in restricted areas are not likely to
cause personnel exposures in excess of the limits specified in 12VAC5-481-640;
and
b. Radiation levels in unrestricted areas do not exceed the
limits specified in 12VAC5-481-720.
2. In addition to the requirements of 12VAC5-481-3400 A 1
subdivision 1 of this subsection, a radiation protection survey
shall also be performed prior to any subsequent medical use and:
a. After making any change in the treatment room shielding;
b. After making any change in the location of the therapeutic
radiation machine within the treatment room;
c. After relocating the therapeutic radiation machine; or
d. Before using the therapeutic radiation machine in a manner
that could result in increased radiation levels in areas outside the external
beam radiation therapy treatment room.
3. The survey record shall indicate all instances where the
facility, in the opinion of the radiation therapy qualified medical
physicist or a private inspector qualified inspector, is in
violation of applicable regulations. The survey record shall also include:
the date of the measurements;, the reason the survey is required;,
the manufacturer's name;, the model number and serial number of
the therapeutic radiation machine;, the instrument(s) instruments
used to measure radiation levels;, a plan of the areas
surrounding the treatment room that were surveyed;, the measured
dose rate at several points in each area expressed in microsieverts or
millirems per hour;, the calculated maximum level of radiation
over a period of one week for each restricted and unrestricted area;,
and the signature of the individual responsible for conducting the survey;
4. If the results of the surveys required by subdivision 1 or
2 of this subsection indicate any radiation levels in excess of the respective
limit specified in subdivision 1 of this subsection, the registrant shall lock
the control in the "OFF" position and not use the unit:
a. Except as may be necessary to repair, replace, or test the
therapeutic radiation machine, the therapeutic radiation machine shielding, or
the treatment room shielding; or
b. Until the registrant has received a specific exemption from
the agency.
B. Modification of radiation therapy unit or room before
beginning a treatment program. If the survey required by subsection A of this
section indicates that an individual in an unrestricted area may be exposed to
levels of radiation greater than those permitted by 12VAC5-481-720, before
beginning the treatment program the registrant shall:
1. Either equip the unit with beam direction interlocks or add
additional radiation shielding to ensure compliance with 12VAC5-481-720;
2. Perform the survey required by subsection A of this section
again; and
3. Include in the report required by subsection D of this
section the results of the initial survey, a description of the modification
made to comply with subdivision 1 of this subsection, and the results of the
second survey; or
4. Request and receive a registration amendment under
12VAC5-481-720 that authorizes radiation levels in unrestricted areas greater
than those permitted by 12VAC5-481-720.
C. Dosimetry equipment.
1. The registrant shall have a calibrated dosimetry system
available for use. The system shall have been calibrated by the National
Institute for Standards and Technology (NIST) or by an American Association of
Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory
(ADCL). The calibration shall have been performed within the previous 24 months
and after any servicing that may have affected system calibration. An
independent survey shall be conducted by a qualified inspector or qualified
medical physicist other than the person performing the original survey prior to
the equipment being used except as described in subsection A of this section:
a. For beams with energies greater than one MV (1 MeV), the
dosimetry system shall have been calibrated for Cobalt-60;
b. For beams with energies equal to or less than one MV (1 MeV),
the dosimetry system shall have been calibrated at an energy (energy range)
appropriate for the radiation being measured;
2. The registrant shall have available for use a dosimetry
system for quality assurance check measurements. To meet this requirement, the
system may be compared with a system that has been calibrated in accordance
with subdivision C 1 of this section subsection. This
comparison shall have been performed within the previous 12 months and after
each servicing that may have affected system calibration. The quality assurance
check system may be the same system used to meet the requirement in subdivision
C 1 of this section subsection;
3. The registrant shall maintain a record of each dosimetry
system calibration, intercomparison, and comparison for the duration of the
license and/or or registration. For each calibration,
intercomparison, or comparison, the record shall include: the date; the model
numbers and serial numbers of the instruments that were calibrated,
inter-compared, or compared as required by subdivisions C 1 and 2 of
this section subsection; the correction factors that were
determined; the names of the individuals who performed the calibration,
intercomparison, or comparison; and evidence that the intercomparison was
performed by, or under the direct supervision and in the physical presence of,
a radiation therapy qualified medical physicist.
D. Reports of external beam radiation therapy surveys and
measurements. The registrant for any therapeutic radiation machine subject to
12VAC5-481-3420 or 12VAC5-481-3430 shall furnish a copy of the records required
in subsections A and B of this section to the agency within 30 days following
completion of the action that initiated the record requirement.
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 Each registrant or applicant subject to
12VAC5-481-3420 and 12VAC5-481-3430 shall develop, implement, and maintain a
quality management program to provide high confidence that radiation will be
administered as directed by the authorized user.
A. Scope and applicability. The quality management program
shall address, at a minimum, the following specific objectives:
1. Written directives.
a. A written directive shall be dated and signed by an
authorized user prior to the administration of radiation. If because of the
patient's condition a delay caused by providing a written revision to an
existing written directive would jeopardize the patient's health, an oral
revision to an existing written directive will be acceptable, provided that the
oral revision is documented as soon as possible in writing in the patient's
record and a revised written directive is signed by an authorized user within
48 hours of the oral revision.
b. The written directive shall contain the patient's or
human research subject's name, type and energy of the beam, total dose, dose
per fraction, treatment site, and number of fractions.
c. A written revision to an existing written directive may
be made provided that the revision is dated and signed by an authorized user
prior to the administration of the therapeutic radiation machine dose or the
next fractional dose.
d. The registrant shall retain a copy of the written
directive for three years.
2. Procedures for administrations. The registrant shall
develop, implement, and maintain written procedures to provide high confidence
that:
a. Prior to the administration of each course of radiation
treatment, the patient's or human research subject's identity is verified by
more than one method as the individual named in the written directive;
b. Each administration is in accordance with the written
directive;
c. Therapeutic radiation machine final plans of treatment
and related calculations are in accordance with the respective written
directives by:
(1) Checking both manual and computer-generated dose
calculations to verify they are correct and in accordance with the written directive;
and
(2) Verifying that any computer-generated calculations are
correctly transferred into the consoles of authorized therapeutic medical
units;
d. Any unintended deviation from the written directive is
identified and evaluated, and appropriate action is taken; and
e. The registrant retains a copy of the procedures for
administrations for the duration of the registration.
B. Reports and notifications of misadministrations.
1. A registrant shall report any event resulting from the
treatment of a patient or human research subject in which the administration of
therapeutic radiation machine radiation results, or will result in, unintended
permanent functional damage to an organ or a physiological system as determined
by a physician.
2. Other than events that result from the treatment of a
patient or human research subject, a registrant shall report any event in which
the administration of a therapeutic radiation machine therapy dose:
a. Involves the wrong patient, wrong treatment modality, or
wrong treatment site;
b. The calculated weekly administered dose differs from the
weekly prescribed dose by more than 30%; or
c. The calculated total administered dose differs from the
total prescribed dose by more than 20% of the total prescribed dose.
3. The registrant shall notify the agency by telephone no
later than the next calendar day after the discovery of a misadministration.
4. The registrant shall submit a written report to the agency
within 15 days after the discovery of a misadministration. The written report
shall include:
a. The registrant's name;
b. The name of the prescribing physician;
c. A brief description of the event;
d. Why the event occurred;
e. The effect, if any, on the individual who received the
misadministration;
f. Actions, if any, that have been taken or are planned to
prevent recurrence; and
g. Certification that the registrant notified the
individual, or the individual's responsible relative or guardian, and if not,
why not.
5. The report shall not contain the individual's name or
any other information that could lead to the identification of the individual.
6. The registrant shall provide notification of the event
to the referring physician and also notify the individual who is the subject of
the misadministration no later than 24 hours after its discovery, unless the
referring physician personally informs the registrant either that he will
inform the individual or that, based on medical judgment, telling the individual
would be harmful. The registrant is not required to notify the individual
without first consulting the referring physician. If the referring physician or
the affected individual cannot be reached within 24 hours, the registrant shall
notify the individual as soon as possible thereafter. The registrant may not
delay any appropriate medical care for the individual, including any necessary
remedial care as a result of the misadministration, because of any delay in
notification. To meet the requirements of this subdivision, the notification of
the individual who is the subject of the misadministration may be made instead
to that individual's responsible relative or guardian. If a verbal notification
is made, the registrant shall inform the individual, or appropriate responsible
relative or guardian, that a written description of the event can be obtained
from the registrant upon request. The registrant shall provide such a written
description if requested.
7. Aside from the notification requirement, nothing in this
section affects any rights or duties of registrants and physicians in relation
to each other, to individuals affected by the misadministration, or to that
individual's responsible relatives or guardians.
8. The registrant shall retain a record of a
misadministration in accordance with subsection C of this section. A copy of
the required record shall be provided to the referring physician if other than
the registrant within 15 days after discovery of the misadministration.
C. Records of misadministrations. A registrant shall
retain a record of misadministrations reported in accordance with subsection B
of this section for three years. The record shall contain the following:
1. The registrant's name and the names of the individuals
involved;
2. The social security number or other identification
number, if one has been assigned, of the individual who is the subject of the
misadministration;
3. A brief description of the event; why it occurred; and
the effect, if any, on the individual;
4. The actions, if any, taken or planned to prevent
recurrence; and
5. Whether the registrant notified the individual, or the
individual's responsible relative or guardian and, if not, whether such failure
to notify was based on guidance from the referring physician.
12VAC5-481-3420. Therapeutic radiation machines of less than
500 kV.
A. Leakage radiation. When the X-ray x-ray tube
is operated at its maximum rated tube current for the maximum kV, the leakage
air kerma rate shall not exceed the value specified at the distance specified
for that classification of therapeutic radiation machine:
1. 5-50 kV Systems systems. The leakage
air kerma rate measured at any position five centimeters from the tube housing
assembly shall not exceed one mGy (100 mrad) in any one hour.
2. > Greater than 50 and < less
than 500 kV Systems systems. The leakage air kerma rate
measured at a distance of one meter from the target in any direction shall not
exceed one cGy (1 rad) in any one hour. This air kerma rate measurement may be
averaged over areas no larger than 100 square centimeters. In addition, the air
kerma rate at a distance of five centimeters from the surface of the tube
housing assembly shall not exceed 30 cGy (30 rad) per hour.
3. For each therapeutic radiation machine, the registrant
shall determine, or obtain from the manufacturer, the leakage radiation
existing at the positions specified in subdivisions A 1 and 2 of this section
subsection for the specified operating conditions. Records on leakage
radiation measurements shall be maintained at the installation for inspection
by the agency.
B. Permanent beam limiting devices. Permanent diaphragms or
cones used for limiting the useful beam shall provide at least the same degree
of attenuation as required for the tube housing assembly.
C. Adjustable or removable beam limiting devices.
1. All adjustable or removable beam limiting devices,
diaphragms, cones or blocks shall not transmit more than 5.0% of the useful
beam for the most penetrating beam used;
2. When adjustable beam limiting devices are used, the
position and shape of the radiation field shall be indicated by a light beam.
D. Filter system. The filter system shall be so designed
that:
1. Filters cannot be accidentally displaced at any possible
tube orientation;
2. For equipment installed after September 20, 2006, an
interlock system prevents irradiation if the proper filter is not in place;
3. The air kerma rate escaping from the filter slot shall not
exceed one cGy (1 rad) per hour at one meter under any operating conditions;
and
4. Each filter shall be marked as to its material of
construction and its thickness.
E. Tube immobilization.
1. The X-ray x-ray tube shall be so mounted that
it cannot accidentally turn or slide with respect to the housing aperture; and
2. The tube housing assembly shall be capable of being immobilized
for stationary portal treatments.
F. Source marking. The tube housing assembly shall be so
marked that it is possible to determine the location of the source to within
five millimeters, and such marking shall be readily accessible for use during
calibration procedures.
G. Beam block. Contact therapy tube housing assemblies shall
have a removable shield of material, equivalent in attenuation to 0.5
millimeters of lead at 100 kV, which can be positioned over the entire useful
beam exit port during periods when the beam is not in use.
H. Timer. A suitable irradiation control device shall be
provided to terminate the irradiation after a pre-set time interval.
1. A timer with a display shall be provided at the treatment
control panel. The timer shall have a pre-set time selector and an elapsed time
or time remaining indicator;
2. The timer shall be a cumulative timer that activates with
an indication of "BEAM-ON" and retains its reading after irradiation
is interrupted or terminated. After irradiation is terminated and before
irradiation can be reinitiated, it shall be necessary to reset the elapsed time
indicator;
3. The timer shall terminate irradiation when a preselected
time has elapsed, if any dose monitoring system present has not previously terminated
irradiation;
4. The timer shall permit accurate pre-setting and
determination of exposure times as short as one second;
5. The timer shall not permit an exposure if set at zero;
6. The timer shall not activate until the shutter is opened
when irradiation is controlled by a shutter mechanism unless calibration
includes a timer error correction to compensate for mechanical lag; and
7. Timer The timer shall be accurate to within
1.0% of the selected value or one second, whichever is greater.
I. Control panel functions. The control panel, in addition to
the displays required by other provisions in this section, shall have:
1. An indication of whether electrical power is available at
the control panel and if activation of the X-ray x-ray tube is
possible;
2. An indication of whether X-rays x-rays are
being produced;
3. A means for indicating X-ray x-ray tube
potential and current;
4. The means for terminating an exposure at any time;
5. A locking device which will prevent unauthorized use of the
therapeutic radiation machine; and
6. For therapeutic radiation machines manufactured after
September 20, 2006, a positive display of specific filter(s) filters
in the beam.
J. Multiple tubes. When a control panel may energize more
than one X-ray x-ray tube:
1. It shall be possible to activate only one X-ray x-ray
tube at any time;
2. There shall be an indication at the control panel
identifying which X-ray x-ray tube is activated; and
3. There shall be an indication at the tube housing assembly
when that tube is energized.
K. Target-to-skin distance (TSD). There shall be a means of
determining the central axis TSD to within one centimeter and of reproducing
this measurement to within two millimeters thereafter.
L. Shutters. Unless it is possible to bring the X-ray x-ray
output to the prescribed exposure parameters within five seconds after the X-ray
x-ray "ON" switch is energized, the beam shall be attenuated
by a shutter having a lead equivalency not less than that of the tube housing
assembly. In addition, after the unit is at operating parameters, the shutter
shall be controlled by the operator from the control panel. An indication of
shutter position shall appear at the control panel.
M. Low filtration X-ray x-ray tubes. Each
therapeutic radiation machine equipped with a beryllium or other low-filtration
window shall be clearly labeled as such upon the tube housing assembly and
shall be provided with a permanent warning device on the control panel that is
activated when no additional filtration is present, to indicate that the dose
rate is very high.
N. Facility design requirements for therapeutic radiation
machines capable of operating in the range 50 kV to 500 kV. In addition to
adequate shielding to meet requirements of 12VAC5-481-3450, the treatment room
shall meet the following design requirements:
1. Aural communication. Provision shall be made for continuous
two-way aural communication between the patient and the operator at the control
panel;
2. Viewing systems. Provision shall be made to permit
continuous observation of the patient during irradiation and the viewing system
shall be so located that the operator can observe the patient from the control
panel. The therapeutic radiation machine shall not be used for patient
irradiation unless at least one viewing system is operational.
O. Additional requirements. Treatment rooms that contain a
therapeutic radiation machine capable of operating above 150 kV shall meet the
following additional requirements:
1. All protective barriers shall be fixed except for entrance
doors or beam interceptors;
2. The control panel shall be located outside the treatment
room or in a totally enclosed booth, which has a ceiling, inside the room;
3. Interlocks shall be provided such that all entrance doors,
including doors to any interior booths, shall be closed before treatment can be
initiated or continued. If the radiation beam is interrupted by any door
opening, it shall not be possible to restore the machine to operation without
closing the door and reinitiating irradiation by manual action at the control
panel; and
4. When any door referred to in subdivision 3 of this
subsection is opened while the X-ray x-ray tube is activated, the
air kerma rate at a distance of one meter from the source shall be reduced to
less than one mGy (100 mrad) per hour.
P. Full calibration measurements.
1. Full calibration of a therapeutic radiation machine subject
to this section shall be performed by, or under the direct supervision of, a radiation
therapy qualified medical physicist:
a. Before the first medical use following installation or
reinstallation of the therapeutic radiation machine;
b. At intervals not exceeding one year; and
c. Before medical use under the following conditions:
(1) Whenever quality assurance check measurements indicate
that the radiation output differs by more than 5.0% from the value obtained at
the last full calibration and the difference cannot be reconciled; and
(2) Following any component replacement, major repair, or
modification of components that could significantly affect the characteristics
of the radiation beam.
d. Notwithstanding the requirements of subdivision 1 c of this
subsection:
(1) Full calibration of therapeutic radiation machines with
multienergy capabilities is required only for those modes and/or or
energies that are not within their acceptable range; and
(2) If the repair, replacement or modification does not affect
all energies, full calibration shall be performed on the affected energy that
is in most frequent clinical use at the facility. The remaining energies may be
validated with quality assurance check procedures against the criteria in
subdivision 1 c (1) of this subsection.
2. To satisfy the requirement of subdivision 1 of this
subsection, full calibration shall include all measurements recommended for
annual calibration by NCRP the National Council on Radiation
Protection and Measurements (NCRP) Report 69, "Dosimetry of X-ray and
Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50
MeV" (1981).
3. The registrant shall maintain a record of each calibration
for the duration of the registration. The record shall include: the date of the
calibration; the manufacturer's name, model number, and serial number for both
the therapeutic radiation machine and the X-ray x-ray tube; the
model numbers and serial numbers of the instruments used to calibrate the
therapeutic radiation machine; and the signature of the radiation therapy
qualified medical physicist responsible for performing the calibration.
Q. Periodic quality assurance checks.
1. Periodic quality assurance checks shall be performed on
therapeutic radiation machines subject to this section, which are capable of
operation at greater than or equal to 50 kV.;
2. To satisfy the requirement of subdivision 1 of this
subsection, quality assurance checks shall meet the following requirements:
a. The registrant shall perform quality assurance checks in
accordance with written procedures established by the radiation therapy qualified
medical physicist.; and
b. The quality assurance check procedures shall specify the
frequency at which tests or measurements are to be performed. The quality
assurance check procedures shall specify that the quality assurance check shall
be performed during the calibration specified in subdivision P 1 of this
section. The acceptable tolerance for each parameter measured in the quality
assurance check, when compared to the value for that parameter determined in
the calibration specified in subdivision P 1 of this section, shall be stated.;
3. The cause for a parameter exceeding a tolerance set by the radiation
therapy qualified medical physicist shall be investigated and
corrected before the system is used for patient irradiation;
4. Whenever a quality assurance check indicates a significant
change in the operating characteristics of a system, as specified in the radiation
therapy qualified medical physicist's quality assurance check
procedures, the system shall be recalibrated as required in subdivision P 1 of
this section;
5. The registrant shall use the dosimetry system described in
12VAC5-481-3400 C 2 to make the quality assurance check required in subdivision
2 of this subsection;
6. The registrant shall have the radiation therapy qualified
medical physicist review and sign the results of each radiation output
quality assurance check within one month 30 days of the date that
the check was performed;
7. The registrant shall ensure that safety quality assurance
checks of therapeutic radiation machines subject to this section are performed
at intervals not to exceed one month 30 days;
8. Notwithstanding the requirements of subdivisions 4 and 7 of
this subsection, the registrant shall ensure that no therapeutic radiation
machine is used to administer radiation to humans unless the quality assurance
checks required by subdivisions 6 4 and 7 of this subsection have
been performed within the 30-day period immediately prior to said administration;
9. To satisfy the requirement of subdivision 7 of this
subsection, safety quality assurance checks shall ensure proper operation of:
a. Electrical interlocks at each external beam radiation
therapy room entrance;
b. The "BEAM-ON" and termination switches;
c. Beam condition indicator lights on the access door(s)
door, control console, and in the radiation therapy room;
d. Viewing systems; and
e. If applicable, electrically operated treatment room doors
from inside and outside the treatment room; and
10. The registrant shall maintain a record of each quality
assurance check required by subdivisions 1 and 7 of this subsection for three
years. The record shall include: the date of the quality assurance
check; the manufacturer's name, the model number, and serial number of the
therapeutic radiation machine; the manufacturer's name;, the
model number, and serial number for the instrument(s) instruments
used to measure the radiation output of the therapeutic radiation machine; and
the signature of the individual who performed the periodic quality assurance
check.
R. Operating procedures.
1. The therapeutic radiation machine shall not be used for
irradiation of patients unless the requirements of subsections P and Q of this
section have been met;
2. Therapeutic radiation machines shall not be left unattended
unless secured pursuant to subdivision I 5 of this section;
3. When a patient must be held in position for radiation
therapy, mechanical supporting or restraining devices shall be used;
4. The tube housing assembly shall not be held by an
individual during operation unless the assembly is designed to require such
holding and the peak tube potential of the system does not exceed 50 kV. In
such cases, the holder shall wear protective gloves and an apron of not
less than 0.5 millimeters lead equivalency at 100 kV;
5. A copy of the current operating and emergency procedures
shall be maintained at the therapeutic radiation machine control console; and
6. No individual other than the patient shall be in the
treatment room during exposures from therapeutic radiation machines operating
above 150 kV. At energies less than or equal to 150 kV, any individual, other
than the patient, in the treatment room shall be protected by a barrier
sufficient to meet the requirements of 12VAC5-481-640.
S. Possession of survey instrument(s) instruments.
Each facility location authorized to use a therapeutic radiation machine in
accordance with this section shall possess appropriately calibrated portable
monitoring equipment. As a minimum, such equipment shall include a portable
radiation measurement survey instrument capable of measuring dose rates over
the range 10 mSv µSv (1 mrem) per hour to 10 mSv (1000 mrem) per
hour. The survey instrument(s) instruments shall be operable and
calibrated in accordance with 12VAC5-481-3440.
T. Electronic brachytherapy devices are subject to the
requirements of 12VAC5-481-3452 and are exempt from the requirements of this
section.
12VAC5-481-3430. Therapeutic radiation machines - photon
therapy systems (500 kV and above) and electron therapy systems (500 kV and
above).
A. Possession of survey instrument(s) instruments.
Each facility location authorized to use a therapeutic radiation machine in
accordance with this section shall possess have access to
appropriately calibrated portable monitoring equipment. As a minimum, such
equipment shall include a portable radiation measurement survey instrument
capable of measuring dose rates over the range 10 mSv µSv (1
mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) instruments
shall be operable and calibrated in accordance with 12VAC5-481-3440.
B. Leakage radiation outside the maximum useful beam in
photon and electron modes.
1. The absorbed dose due to leakage radiation (excluding
neutrons) at any point outside the maximum sized useful beam, but within a
circular plane of radius two meters which is perpendicular to and centered on
the central axis of the useful beam at the nominal treatment distance (i.e.,
patient plane), shall not exceed a maximum of 0.2% and an average of 0.1% of
the absorbed dose on the central axis of the beam at the nominal treatment
distance. Measurements shall be averaged over an area not exceeding 100 square
centimeters at a minimum of 16 points uniformly distributed in the plane;
2. Except for the area defined in subdivision 1 of this
subsection, the absorbed dose due to leakage radiation (excluding neutrons) at
one meter from the electron path between the electron source and the target or
electron window shall not exceed 0.5% of the absorbed dose on the central axis
of the beam at the nominal treatment distance. Measurements shall be averaged
over an area not exceeding 100 square centimeters;
3. For equipment manufactured after September 20, 2006, the
neutron absorbed dose outside the useful beam shall be in compliance with
International Electrotechnical Commission (IEC) Document 601-2-1 (most current
revision); and
4. For each therapeutic radiation machine, the registrant
shall determine, or obtain from the manufacturer, the leakage radiation
existing at the positions specified in subdivisions 1 through, 2, and
3 of this subsection for the specified operating conditions. Records on leakage
radiation measurements shall be maintained at the installation for inspection
by the agency.
C. Leakage radiation through beam limiting devices.
1. Photon radiation. All adjustable or interchangeable beam
limiting devices shall attenuate the useful beam such that at the nominal
treatment distance, the maximum absorbed dose anywhere in the area shielded by
the beam limiting device(s) devices shall not exceed 2.0% of the
maximum absorbed dose on the central axis of the useful beam measured in a 10
centimeter by 10 centimeter radiation field, or for multileaf collimators,
shall not exceed manufacturer's specifications 100 square centimeter
radiation field, or maximum available field size if less than 100 square
centimeters;
2. Electron radiation. All adjustable or interchangeable
electron applicators shall attenuate the radiation, including but not limited
to photon radiation generated by electrons incident on the beam limiting device
and electron applicator and other parts of the radiation head, such that the
absorbed dose in a plane perpendicular to the central axis of the useful beam
at the nominal treatment distance shall not exceed:
a. A maximum of 2.0% and average of 0.5% of the absorbed dose
on the central axis of the useful beam at the nominal treatment distance. This
limit shall apply beyond a line seven centimeters outside the periphery of the
useful beam; and
b. A maximum of 10% of the absorbed dose on the central axis
of the useful beam at the nominal treatment distance. This limit shall apply
beyond a line two centimeters outside the periphery of the useful beam.
3. Measurement of leakage radiation.
a. Photon radiation. Measurements of leakage radiation through
the beam limiting devices shall be made with the beam limiting devices closed
and any residual aperture blocked by at least two-tenth value two
tenth-value layers of suitable absorbing material. In the case of
overlapping beam limiting devices, the leakage radiation through each set shall
be measured independently at the depth of maximum dose. Measurements shall be
made using a radiation detector of area not exceeding 10 square centimeters;
b. Electron radiation. Measurements of leakage radiation
through the electron applicators shall be made with the electron beam directed
into the air and using a radiation detector of area up to but not exceeding one
square centimeter suitably protected against radiation which has been scattered
from material beyond the radiation detector. Measurements shall be made using
one centimeter of water equivalent build up material.
D. Filters and wedges.
1. Each wedge filter that is removable from the system shall
be clearly marked with an identification number. For removable wedge filters,
the nominal wedge angle shall appear on the wedge or wedge tray (if permanently
mounted to the tray). If the wedge or wedge tray is significantly damaged, the
wedge transmission factor shall be redetermined;.
2. If the absorbed dose rate information required by
subsection I of this section relates exclusively to operation with a field
flattening filter or beam scattering foil in place, such foil or filter shall
be removable only by the use of tools;.
3. For equipment manufactured after September 20, 2006, that
utilizes wedge filters, interchangeable field flattening filters, or
interchangeable beam scattering foils:
a. Irradiation shall not be possible until a selection of a
filter or a positive selection to use "no filter" has been made at
the treatment control panel, either manually or automatically;
b. An interlock system shall be provided to prevent
irradiation if the filter selected is not in the correct position;
c. A display shall be provided at the treatment control panel
showing the wedge filter(s) filters, interchangeable field
flattening filter(s) filters, and/or or
interchangeable beam scattering foil(s) foils in use; and
d. An interlock shall be provided to prevent irradiation if
any filter and/or or beam scattering foil selection operation
carried out in the treatment room does not agree with the filter and/or or
beam scattering foil selection operation carried out at the treatment control
panel.
E. Stray radiation in the useful beam. For equipment
manufactured after September 20, 2006, the registrant shall determine during
acceptance testing, or obtain from the manufacturer, data sufficient to ensure
that X-ray x-ray stray radiation in the useful electron beam,
absorbed dose at the surface during X-ray x-ray irradiation,
and stray neutron radiation in the useful X-ray x-ray beam are in
compliance with International Electrotechnical Commission (IEC) Document
601-2-1 (most current revision).
F. Beam monitors. All therapeutic radiation machines subject
to this section shall be provided with redundant beam monitoring systems. The
sensors for these systems shall be fixed in the useful beam during treatment to
indicate the dose monitor unit rate.
1. Equipment manufactured after September 20, 2006, shall be
provided with at least two independently powered integrating dose meters.
Alternatively, common elements may be used if the production of radiation is
terminated upon failure of any common element.
2. Equipment manufactured on or before September 20, 2006,
shall be provided with at least one radiation detector. This detector shall be
incorporated into a useful beam monitoring system;.
3. The detector and the system into which that detector is
incorporated shall meet the following requirements:
a. Each detector shall be removable only with tools and, if
movable, shall be interlocked to prevent incorrect positioning;.
b. Each detector shall form part of a beam monitoring system
from whose readings in dose monitor units the absorbed dose at a reference
point can be calculated;.
c. Each beam monitoring system shall be capable of
independently monitoring, interrupting, and terminating irradiation; and.
d. For equipment manufactured after September 20, 2006, the
design of the beam monitoring systems shall ensure that the:
(1) Malfunctioning of one system shall not affect the correct
functioning of the other system(s) systems; and
(2) Failure of either system shall terminate irradiation or
prevent the initiation of radiation.
e. Each beam monitoring system shall have a legible display at
the treatment control panel. For equipment manufactured after September 20,
2006, each display shall:
(1) Maintain a reading until intentionally reset;
(2) Have only one scale and no electrical or mechanical scale
multiplying factors;
(3) Utilize a design such that increasing dose is displayed by
increasing numbers; and
(4) In the event of power failure, the beam monitoring
information required in subdivision 3 e (3) of this subsection displayed at the
control panel at the time of failure shall be retrievable in at least one
system for a 20-minute period of time.
G. Beam symmetry.
1. Bent-beam linear accelerators A bent-beam linear
accelerator with beam flattening filter subject to this section shall be
provided with an auxiliary device(s) device to monitor
beam symmetry;
2. The device(s) device referenced in
subdivision 1 of this subsection shall be able to detect field asymmetry
greater than 10%; and
3. The device(s) device referenced in
subdivision 1 of this subsection shall be configured to terminate irradiation
if the specifications in subdivision 2 of this subsection cannot be maintained.
H. Selection and display of dose monitor units.
1. Irradiation shall not be possible until a new selection of
a number of dose monitor units has been made at the treatment control panel;
2. The preselected number of dose monitor units shall be
displayed at the treatment control panel until reset manually for the next
irradiation;
3. After termination of irradiation, it shall be necessary to
reset the dosimeter display before subsequent treatment can be initiated; and
4. For equipment manufactured after September 20, 2006, after
termination of irradiation, it shall be necessary for the operator to reset the
preselected dose monitor units before irradiation can be initiated.
I. Air kerma rate or absorbed dose rate. For equipment
manufactured after September 20, 2006, a system shall be provided from whose
readings the air kerma rate or absorbed dose rate at a reference point can be
calculated. (The radiation detectors specified in subsection F of this section
may form part of this system.) In addition:
1. The dose monitor unit rate shall be displayed at the
treatment control panel;
2. If the equipment can deliver under any conditions an air
kerma rate or absorbed dose rate at the nominal treatment distance more than
twice the maximum value specified by the manufacturer, a device shall be
provided that terminates irradiation when the air kerma rate or absorbed dose
rate exceeds a value twice the specified maximum. The dose rate at which the
irradiation will be terminated shall be a record maintained by the registrant;
3. If the equipment can deliver under any fault condition(s)
conditions an air kerma rate or absorbed dose rate at the nominal
treatment distance more than 10 times the maximum value specified by the
manufacturer, a device shall be provided to prevent the air kerma rate or
absorbed dose rate anywhere in the radiation field from exceeding twice the
specified maximum value and to terminate irradiation if the excess absorbed
dose at the nominal treatment distance exceeds 4 Gy (400 rad); and
4. For each therapeutic radiation machine, the registrant
shall determine, or obtain from the manufacturer, the maximum value(s) values
specified in subdivisions 2 and 3 of this subsection for the specified
operating conditions. Records of these maximum value(s) values
shall be maintained at the installation for inspection by the agency.
J. Termination of irradiation by the beam monitoring system
or systems during stationary beam radiation therapy.
1. Each primary system shall terminate irradiation when the
preselected number of dose monitor units has been detected by the system;
2. If the original design of the equipment included a
secondary dose monitoring system, that system shall be capable of terminating
irradiation when not more than 15% or 40 dose monitor units above the
preselected number of dose monitor units set at the control panel has been
detected by the secondary dose monitoring system; and
3. For equipment manufactured after September 20, 2006, an
indicator on the control panel shall show which monitoring system has
terminated irradiation.
K. Termination of irradiation. It shall be possible to
terminate irradiation and equipment movement or go from an interruption
condition to termination condition at any time from the operator's position at
the treatment control panel.
L. Interruption of irradiation. If a therapeutic radiation
machine has an interrupt mode, it shall be possible to interrupt irradiation
and equipment movements at any time from the treatment control panel. Following
an interruption it shall be possible to restart irradiation by operator action
without any reselection of operating conditions. If any change is made of a
preselected value during an interruption, irradiation and equipment movements
shall be automatically terminated.
M. Timer. A suitable irradiation control device shall be
provided to terminate the irradiation after a pre-set time interval.
1. A timer shall be provided which has a display at the
treatment control panel. The timer shall have a pre-set time selector and an
elapsed time indicator;
2. The timer shall be a cumulative timer that activates with
an indication of "BEAM-ON" and retains its reading after irradiation
is interrupted or terminated. After irradiation is terminated and before
irradiation can be reinitiated, it shall be necessary to reset the elapsed time
indicator;
3. The timer shall terminate irradiation when a preselected
time has elapsed, if the dose monitoring systems have not previously
terminated irradiation.
N. Selection of radiation type. Equipment capable of both X-ray
x-ray therapy and electron therapy shall meet the following additional
requirements:
1. Irradiation shall not be possible until a selection of
radiation type (X-rays (x-rays or electrons) has been made at the
treatment control panel;
2. The radiation type selected shall be displayed at the
treatment control panel before and during irradiation;
3. An interlock system shall be provided to ensure that the
equipment can principally emit only the radiation type that has been selected;
4. An interlock system shall be provided to prevent
irradiation with X-rays x-rays, except to obtain an image, when
electron applicators are fitted;
5. An interlock system shall be provided to prevent
irradiation with electrons when accessories specific for X-ray x-ray
therapy are fitted; and
6. An interlock system shall be provided to prevent
irradiation if any selected operations carried out in the treatment room do not
agree with the selected operations carried out at the treatment control panel.
O. Selection of energy. Equipment capable of generating
radiation beams of different energies shall meet the following requirements:
1. Irradiation shall not be possible until a selection of
energy has been made at the treatment control panel;
2. The nominal energy value selected shall be displayed at the
treatment control panel until reset manually for the next irradiation. After
termination of irradiation, it shall be necessary to reset the nominal energy
value selected before subsequent treatment can be initiated;
3. Irradiation shall not be possible until the appropriate
flattening filter or scattering foil for the selected energy is in its proper
location; and
4. For equipment manufactured after September 20, 2006, the
selection of energy shall be in compliance with International Electrotechnical
Commission (IEC) Document 601-2-1.
P. Selection of stationary beam radiation therapy or moving
beam radiation therapy. Therapeutic radiation machines capable of both
stationary beam radiation therapy and moving beam radiation therapy shall meet
the following requirements:
1. Irradiation shall not be possible until a selection of
stationary beam radiation therapy or moving beam radiation therapy has been
made at the treatment control panel;
2. The mode of operation shall be displayed at the treatment
control panel;
3. An interlock system shall be provided to ensure that the
equipment can operate only in the mode that has been selected;
4. An interlock system shall be provided to prevent
irradiation if any selected parameter in the treatment room does not agree with
the selected parameter at the treatment control panel;
5. Moving beam radiation therapy shall be controlled to obtain
the selected relationships between incremental dose monitor units and
incremental movement. For equipment manufactured after September 20, 2006:
a. An interlock system shall be provided to terminate
irradiation if the number of dose monitor units delivered in any 10 degrees of
rotation or one cm centimeter of linear motion differs by more
than 20% from the selected value;
b. Where angle terminates the irradiation in moving beam
radiation therapy, the dose monitor units delivered shall differ by less than
5.0% from the dose monitor unit value selected;
c. An interlock shall be provided to prevent motion of more
than five degrees or one cm centimeter beyond the selected limits
during moving beam radiation therapy;
d. An interlock shall be provided to require that a selection
of direction be made at the treatment control panel in all units that are
capable of both clockwise and counter-clockwise moving beam radiation therapy.;
e. Moving beam radiation therapy shall be controlled with both
primary position sensors and secondary position sensors to obtain the selected
relationships between incremental dose monitor units and incremental movement.;
6. Where the beam monitor system terminates the irradiation in
moving beam radiation therapy, the termination of irradiation shall be as
required by 12VAC5-481-3430 J subsection J of this section; and
7. For equipment manufactured after September 20, 2006, an
interlock system shall be provided to terminate irradiation if movement:
a. Occurs during stationary beam radiation therapy; or
b. Does not start or stops during moving beam radiation
therapy unless such stoppage is a pre-planned function.
Q. Facility design requirements for therapeutic radiation
machines operating above 500 kV. In addition to shielding adequate to meet
requirements of 12VAC5-481-3450, the following design requirements are made:
1. Protective barriers. All protective barriers shall be
fixed, except for access doors to the treatment room or movable beam
interceptors;
2. Control panel. In addition to other requirements specified
in Part XV (12VAC5-481-3380 et seq.) of this chapter, the control panel shall
also:
a. Be located outside the treatment room;
b. Provide an indication of whether electrical power is
available at the control panel and if activation of the radiation is possible;
c. Provide an indication of whether radiation is being
produced; and
d. Include an access control (locking) device that will
prevent unauthorized use of the therapeutic radiation machine;
3. Viewing systems. Windows, mirrors, closed-circuit
television or an equivalent viewing system shall be provided to permit
continuous observation of the patient following positioning and during
irradiation and shall be so located that the operator may observe the patient
from the treatment control panel. The therapeutic radiation machine shall not
be used for patient irradiation unless at least one viewing system is
operational;
4. Aural communications. Provision shall be made for
continuous two-way aural communication between the patient and the
operator at the control panel. The therapeutic radiation machine shall not be
used for irradiation of patients unless continuous two-way aural
communication is possible;
5. Room entrances. Treatment room entrances shall be provided
with warning lights in a readily observable position near the outside of all
access doors, which will indicate when the useful beam is "ON" and
when it is "OFF";
6. Entrance interlocks. Interlocks shall be provided such that
all access controls are activated before treatment can be initiated or
continued. If the radiation beam is interrupted by any access control, it shall
not be possible to restore the machine to operation without resetting the
access control and reinitiating irradiation by manual action at the control
panel;
7. Beam interceptor interlocks. If the shielding material in
any protective barrier requires the presence of a beam interceptor to ensure
compliance with 12VAC5-481-720, interlocks shall be provided to prevent the
production of radiation, unless the beam interceptor is in place, whenever the
useful beam is directed at the designated barrier(s) barrier;
8. Emergency cutoff switches. At least one emergency power
cutoff switch shall be located in the radiation therapy room and shall
terminate all equipment electrical power including radiation and mechanical
motion. This switch is in addition to the termination switch required by
subsection K of this section. All emergency power cutoff switches shall include
a manual reset so that the therapeutic radiation machine cannot be restarted
from the unit's control console without resetting the emergency cutoff switch;
9. Safety interlocks. All safety interlocks shall be designed
so that any defect or component failure in the safety interlock system prevents
or terminates operation of the therapeutic radiation machine; and
10. Surveys for residual radiation. Surveys for residual
activity shall be conducted on all therapeutic radiation machines capable of
generating photon and electron energies above 10 MV prior to machining,
removing from treatment room, or working on therapeutic radiation
machine components which may have become activated due to photo-neutron
production.
R. Radiation therapy Qualified medical
physicist support.
1. The services of a radiation therapy qualified
medical physicist shall be required in facilities having therapeutic
radiation machines with energies of 500 kV and above. The radiation therapy
qualified medical physicist shall be responsible for:
a. Full calibration(s) calibrations required by
subsection T of this section and protection surveys required by
12VAC5-481-3400 A;
b. Supervision and review of dosimetry;
c. Beam data acquisition and transfer for computerized
dosimetry, and supervision of its use;
d. Quality assurance, including quality assurance check review
required by subdivision U 5 of this section.;
e. Consultation with the authorized user in treatment
planning, as needed; and
f. Performance of calculations or assessments regarding
misadministrations.
2. If the radiation therapy qualified medical
physicist is not a full-time employee of the registrant, the operating
procedures required by subsection S of this section shall also specifically
address how the radiation therapy qualified medical physicist is
to be contacted for problems or emergencies, as well as the specific actions,
if any, to be taken until the radiation therapy qualified medical
physicist can be contacted.
S. Operating procedures.
1. No individual, other than the patient, shall be in the
treatment room during treatment or during any irradiation for testing or
calibration purposes;
2. Therapeutic radiation machines shall not be made available
for medical use unless the requirements of 12VAC5-481-3400 A, and subsections T
and U of this section have been met;
3. Therapeutic radiation machines, when not in operation,
shall be secured to prevent unauthorized use;
4. When adjustable beam limiting devices are used, the
position and shape of the radiation field shall be indicated by a light field.
5. If a patient must be held in position during treatment,
mechanical supporting or restraining devices shall be used; and
6. A copy of the current operating and emergency procedures
shall be maintained at the therapeutic radiation machine control console.
T. Acceptance testing, commissioning, and full
calibration measurements.
1. Acceptance testing, commissioning and full calibration of a
therapeutic radiation machine subject to this section shall be performed by, or
under the direct supervision of, a radiation therapy qualified
medical physicist.
2. Acceptance testing and commissioning shall be performed in
accordance with the American Association of Physicists in Medicine (AAPM)
AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Report
Number 47," prepared by Radiation Therapy Task Group 45"
and the manufacturer's contractual specifications. Acceptance testing and
commissioning shall be conducted before the first medical use following
installation or reinstallation of the therapeutic radiation machine.
3. Full calibration shall include measurement of all
parameters required by Table II of "Comprehensive QA for Radiation
Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46,"
prepared by Committee Task Group 40" and shall be performed in
accordance with "AAPM Code of Practice for Radiotherapy Accelerators: Report
of AAPM AAPM Report No. 47" prepared by Radiation Therapy Task
Group 45". Although it shall not be necessary to complete all
elements of a full calibration at the same time, all parameters (for all
energies) shall be completed at intervals not exceeding 12 calendar months,
unless a more frequent interval is required in Table II.
4. The radiation therapy qualified medical
physicist shall perform all elements of a full calibration necessary to
determine that all parameters are within acceptable limits:
a. Whenever quality assurance check measurements indicate that
the radiation output differs by more than 5.0% from the value obtained at the
last full calibration and the difference cannot be reconciled. Therapeutic
radiation machines with multienergy and/or or multimode
capabilities shall only require measurements for those modes and/or or
energies that are not within their acceptable range; and
b. Following any component replacement, major repair, or
modification of components that could significantly affect the characteristics
of the radiation beam. If the repair, replacement or modification does not
affect all modes and/or or energies, measurements shall be
performed on the effected mode or energy that is in most frequent
clinical use at the facility. The remaining energies or modes may be
validated with quality assurance check procedures against the criteria in
subdivision 4 a of this subsection.
5. The registrant shall maintain a record of each calibration
in an auditable form for the duration of the registration. The record shall
include: the date of the calibration; the manufacturer's name, model
number, and serial number for the therapeutic radiation machine; the
model numbers and serial numbers of the instruments used to calibrate the
therapeutic radiation machine; and the signature of the radiation therapy
qualified medical physicist responsible for performing the calibration.
U. Periodic quality assurance checks.
1. Periodic quality assurance checks shall be performed on all
therapeutic radiation machines subject to this section at intervals not to
exceed those specified in "Comprehensive QA for Radiation Oncology: Report
of AAPM Report No. 46," prepared by AAPM Radiation Therapy
Committee Task Group 40";
2. To satisfy the requirement of subdivision 1 of this
subsection, quality assurance checks shall include determination of central
axis radiation output and a representative sampling of periodic quality
assurance checks contained in "Comprehensive QA for Radiation Oncology: Report
of AAPM Report No. 46" prepared by AAPM Radiation Therapy
Committee Task Group 40". Representative sampling shall include all
referenced periodic quality assurance checks in an interval not to exceed 12
consecutive calendar months;
3. The registrant shall use a dosimetry system that has been
inter-compared within the previous 12 months with the dosimetry system
described in 12VAC5-481-3400 C 1 to make the periodic quality assurance checks
required in subdivision 2 of this subsection;
4. The registrant shall perform periodic quality assurance
checks required by subdivision 1 of this subsection in accordance with
procedures established by the radiation therapy qualified medical
physicist;
5. The registrant shall review the results of each periodic
radiation output check according to the following procedures:
a. The authorized user and radiation therapy qualified
medical physicist shall be immediately notified if any parameter is not
within its acceptable tolerance. The therapeutic radiation machine shall not be
made available for subsequent medical use until the radiation therapy qualified
medical physicist has determined that all parameters are within their
acceptable tolerances;
b. If all quality assurance check parameters appear to be
within their acceptable ranges, the quality assurance check shall be reviewed
and signed by either the authorized user or radiation therapy qualified
medical physicist within three treatment days; and
c. The radiation therapy qualified medical
physicist shall review and sign the results of each radiation output quality
assurance check at intervals not to exceed one month 30 days.
6. Therapeutic radiation machines subject to this section
shall have applicable safety quality assurance checks listed in
"Comprehensive QA for Radiation Oncology: Report of AAPM Report
No. 46," prepared by AAPM Radiation Therapy Committee Task Group 40"
performed at intervals not to exceed one week;
7. To satisfy the requirement of subdivision 6 of this
subsection, safety quality assurance checks shall ensure proper operation of:
a. Electrical interlocks at each external beam radiation
therapy room entrance;
b. Proper operation of the "BEAM-ON," interrupt,
and termination switches;
c. Beam condition indicator lights on the access doors,
control console, and in the radiation therapy room;
d. Viewing systems;
e. Electrically operated treatment room door(s) doors
from inside and outside the treatment room;
f. At least one emergency power cutoff switch. If more than
one emergency power cutoff switch is installed and not all switches are tested
at once, each switch shall be tested on a rotating basis. Safety quality
assurance checks of the emergency power cutoff switches may be conducted at the
end of the treatment day in order to minimize possible stability problems with
the therapeutic radiation machine.
8. The registrant shall promptly repair any system identified
in subdivision 7 of this subsection that is not operating properly; and
9. The registrant shall maintain a record of each quality
assurance check required by subdivisions 1 and 7 of this subsection for three
years. The record shall include: the date of the quality assurance check; the
manufacturer's name, model number, and serial number of the therapeutic
radiation machine; the manufacturer's name, model number and serial number for
the instrument(s) instruments used to measure the radiation
output of the therapeutic radiation machine; and the signature of the
individual who performed the periodic quality assurance check.
V. Quality assurance checks for intensity modulated
radiation therapy (IMRT) shall:
1. Include commissioning and testing of the treatment
planning and delivery systems, routine quality assurance of the delivery
system, and patient-specific validation of treatment plans;
2. Be performed in accordance with "Guidance document
on delivery, treatment planning, and clinical implementation of IMRT: Report of
the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No.
82"; and
3. Be performed in accordance with the manufacturer's
contractual specifications.
12VAC5-481-3450. Shielding and safety design requirements.
A. Each therapeutic radiation machine subject to
12VAC5-481-3420 or 12VAC5-481-3430 shall be provided with such primary and/or
or secondary barriers as are necessary to ensure compliance with
12VAC5-481-640 and 12VAC5-481-720.
B. Facility design information for all new installations of a
therapeutic radiation machine or installations of a therapeutic radiation
machine of higher energy into a room not previously approved for that energy
shall be submitted for agency approval prior to actual installation of the
therapeutic radiation machine. At a minimum, facility design information
shall include:
1. All therapeutic radiation machines.
a. Basic facility information including name, telephone
number, and agency registration number of the individual responsible for
preparation of the shielding plan; name and telephone number of the facility
supervisor; and the street address, including room number, of the therapeutic
radiation machine facility. The plan shall also indicate whether this is a new
structure or a modification to an existing structure.
b. The primary areas where all wall, floor, and ceiling
areas are struck by the useful beam.
c. The secondary barriers where all wall, floor, and
ceiling areas do not have primary barriers.
2. Therapeutic radiation machines less than or equal to 150
kV (photons only). In addition to the requirements listed in subdivision 1 of
this subsection, therapeutic radiation machine facilities that produce only
photons with a maximum energy less than or equal to 150 kV shall submit
shielding plans that contain, at a minimum, the following additional
information:
a. Equipment specifications, including the manufacturer and
model number of the therapeutic radiation machine, as well as the maximum
technique factors;
b. Maximum design workload for the facility including total
weekly radiation output, expressed in gray (rad) or air kerma at one meter;
total beam-on time per day or per week; average treatment time per patient; and
the anticipated number of patients to be treated per day or per week;
c. A facility blueprint or drawing indicating scale (0.25
inch equals 1 foot is typical); direction of north; normal location of the
therapeutic radiation machine's radiation port; the port's travel and traverse
limits; general direction of the useful beam; locations of any windows and
doors; and location of the therapeutic radiation machine control panel. If the
control panel is located inside the therapeutic radiation machine treatment
room, the location of the operator's booth shall be noted on the plan and the
operator's station at the control panel shall be behind a protective barrier
sufficient to ensure compliance with 12VAC5-481-640;
d. The structural composition and thickness or lead or
concrete equivalent of all walls, doors, partitions, floor, and ceiling of the
room concerned;
e. The type of occupancy of all adjacent areas inclusive of
space above and below the room concerned. If there is an exterior wall, the
distance to the closest areas where it is likely that individuals may be
present shall be included; and
f. At least one example calculation that shows the
methodology used to determine the amount of shielding required for each
physical condition (e.g., primary, secondary, and leakage barriers; restricted
and unrestricted areas; and entry doors) and shielding material in the facility:
(1) If commercial software is used to generate shielding
requirements, the software used and the version and revision date shall be
identified.
(2) If the software used to generate shielding requirements
is not in the open literature, quality control sample calculations to verify
the result obtained with the software shall be submitted.
3. Therapeutic radiation machines over 150 kV. In addition
to the requirements listed in subdivision 1 of this subsection, therapeutic
radiation machine facilities that produce photons with a maximum energy in
excess of 150 kV or electrons, or both, shall submit shielding plans that
contain, at a minimum, the following additional information:
a. Equipment specifications including the manufacturer and
model number of the therapeutic radiation machine, gray (rad) at the isocenter,
and the energy and type of radiation produced (e.g., photon, electron). The
target to isocenter distance shall be specified;
b. Maximum design workload for the facility including total
weekly radiation output, expressed in gray (rad) at one meter; total beam-on
time per day or per week; the average treatment time per patient; and the
anticipated number of patients to be treated per day or per week;
c. Facility blueprint or drawing, including both floor plan
and elevation views, indicating relative orientation of the therapeutic
radiation machine; scale (0.25 inch equals 1 foot is typical); type, thickness,
and minimum density of shielding material; direction of north, locations and
size of all penetrations through each shielding barrier (ceiling, walls, and
floor); and details of the door and maze;
d. The structural composition and thickness or concrete
equivalent of walls, doors, partitions, floor, and ceiling of the room
concerned;
e. The type of occupancy of all adjacent areas inclusive of
space above and below the room concerned. If there is an exterior wall, the
distance to the closest areas where it is likely that individuals may be
present shall be included;
f. Description of all assumptions that were used in
shielding calculations including, but not limited to, design energy (e.g., room
may be designed for 6 MV unit although only a 4 MV unit is currently proposed),
workload, presence of integral beam-stop in unit, occupancy and use of adjacent
areas, fraction of time that useful beam will intercept each permanent barrier
(walls, floor, and ceiling), and "allowed" radiation exposure in both
restricted and unrestricted areas; and
g. At least one example calculation that shows the
methodology used to determine the amount of shielding required for each
physical condition (e.g., primary, secondary, and leakage barriers; restricted
and unrestricted areas; small angle scatter; entry doors; and maze), and
shielding material in the facility.
(1) If commercial software is used to generate shielding
requirements, the software used and the version and revision date shall be
identified; and
(2) If the software used to generate shielding requirements
is not in the open literature, quality control sample calculations to verify
the result obtained with the software shall be submitted.
4. Neutron shielding. In addition to the requirements
listed in subdivision 3 of this subsection, therapeutic radiation machine
facilities that are capable of operating above 10 MV shall submit shielding
plans that contain, at a minimum, the following additional information:
a. The structural composition, thickness, minimum density,
and location of all neutron shielding material;
b. Description of all assumptions that were used in neutron
shielding calculations including, but not limited to, neutron spectra as a
function of energy, neutron fluence rate, absorbed dose and dose equivalent
(due to neutrons) in both restricted and unrestricted areas;
c. At least one example calculation that shows the
methodology used to determine the amount of neutron shielding required for each
physical condition (e.g., restricted and unrestricted areas, entry doors, and
maze), and neutron shielding material utilized in the facility.
(1) If commercial software is used to generate shielding
requirements, the software used and the version and revision date shall be
identified; and
(2) If the software used to generate shielding requirements
is not in the open literature, control sample calculations to verify the result
obtained with the software shall be submitted.
d. The methods and instrumentation that will be used to
verify the adequacy of all neutron shielding installed in the facility.
12VAC5-481-3451. Quality assurance for radiation therapy
simulation systems.
Quality assurance for a conventional or virtual simulator
shall include acceptance testing and periodic verification of system
performance and shall be performed in accordance with (i) "Comprehensive
QA for Radiation Oncology: AAPM Report No. 46, Report of AAPM Radiation Therapy
Committee Task Group No.40" for a conventional simulator or (ii)
"Quality assurance for computed tomography simulators and the computed
tomography-simulation process: AAPM Report No. 83, Report of the AAPM Radiation
Therapy Committee Task Group No. 66" for a virtual simulator.
12VAC5-481-3452. Electronic brachytherapy.
A. Applicability. Electronic brachytherapy devices shall
be subject to the requirements of this section and shall be exempt for the
requirements of 12VAC5-481-3420.
1. An electronic brachytherapy device that does not meet
the requirements of this section shall not be used for irradiation of patients;
and
2. An electronic brachytherapy device shall only be
utilized for human use applications specifically approved by the U.S. Food and
Drug Administration (FDA) unless participating in a research study approved by
the registrant's institutional review board (IRB).
B. Possession of survey instruments. Each facility
location authorized to use an electronic brachytherapy device in accordance
with this section shall have access to appropriately calibrated portable
monitoring equipment. At a minimum, such equipment shall include a portable
radiation measurement survey instrument capable of measuring dose rates over
the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey
instruments shall be operable and calibrated in accordance with 12VAC5-481-3440
for the applicable electronic brachytherapy source energy.
C. Facility design requirements for electronic brachytherapy
devices. In addition to shielding adequate to meet requirements of
12VAC5-481-3450, the treatment room shall meet the following design
requirements:
1. If applicable, provision shall be made to prevent
simultaneous operation of more than one therapeutic radiation machine in a
treatment room.
2. Access to the treatment room shall be controlled by a
door at each entrance.
3. Each treatment room shall have provisions to permit
continuous aural communication and visual observation of the patient from the
treatment control panel during irradiation. The electronic brachytherapy device
shall not be used for patient irradiation unless the patient can be observed.
4. For electronic brachytherapy devices capable of
operating below 50 kV, radiation shielding for the staff in the treatment room
shall be available, either as a portable shield or as localized shielded
material around the treatment site.
5. For electronic brachytherapy devices capable of
operating at greater than 150 kV:
a. The control panel shall be located outside the treatment
room; and
b. Electrical interlocks shall be provided for all doors to
the treatment room that will:
(a) Prevent the operator from initiating the treatment
cycle unless each treatment room entrance door is closed;
(b) Cause the source to be shielded when an entrance door
is opened; and
(c) Prevent the source from being exposed following an
interlock interruption until all treatment room entrance doors are closed and
the source on-off control is reset at the console.
D. Electrical safety for
electronic brachytherapy devices.
1. The high voltage transformer shall be electrically
isolated to prevent electrical and magnetic interference with the surrounding
environment and ancillary equipment.
2. The high voltage transformer shall be isolated from
personnel (e.g., an operator) and the environment by a protective housing that
can only be accessed through a cover requiring a tool for access or with
electrical interlocks to prevent operation while open.
3. The high voltage transformer shall have appropriate
safety labels warning personnel of potential electrical shock or heat related
injuries.
4. Equipment manufactured after March 2009 shall be in
compliance with the most current revision of the following International
Electrotechnical Commission (IEC) Documents:
a. IEC 60601-1:1998+A1+A2:1995;
b. IEC 60601-1-2:2001;
c. IEC 60601-2-8:1999; and
d. IEC 60601-2-17:2004.
E. Control panel functions. The control panel, in addition
to the displays required by other provisions in this section, shall:
1. Provide an indication of whether electrical power is
available at the control panel and if activation of the electronic
brachytherapy source is possible;
2. Provide an indication of whether x-rays are being
produced;
3. Provide a means for indicating electronic brachytherapy
source potential and current;
4. Provide the means for terminating an exposure at any
time; and
5. Include an access control (locking) device that will
prevent unauthorized use of the electronic brachytherapy device.
F. Timer. A suitable irradiation control device (timer)
shall be provided to terminate the irradiation after a pre-set time interval or
integrated charge on a dosimeter-based monitor.
1. A timer shall be provided at the treatment control
panel. The timer shall indicate planned setting and the time elapsed or
remaining;
2. The timer shall not permit an exposure if set at zero;
3. The timer shall be a cumulative device that activates
with an indication of "BEAM-ON" and retains its reading after
irradiation is interrupted or terminated. After irradiation is terminated and
before irradiation can be reinitiated, it shall be necessary to reset the
elapsed time indicator;
4. The timer shall terminate irradiation when a preselected
time has elapsed if any dose monitoring system has not previously terminated
irradiation.
5. The timer shall permit setting of exposure times as
short as 0.1 second; and
6. The timer shall be accurate to within 1.0% of the
selected value or 0.1 second, whichever is greater.
G. Qualified medical physicist support.
1. The services of a qualified medical physicist shall be
required in facilities having electronic brachytherapy devices. The qualified
medical physicist shall be responsible for:
a. Evaluation of the output from the electronic brachytherapy
source;
b. Generation of the necessary dosimetric information;
c. Supervision and review of treatment calculations prior
to initial treatment of any treatment site;
d. Establishing the periodic and day-of-use quality
assurance checks and reviewing the data from those checks as required in
subsection K of this section;
e. Consultation with the authorized user in treatment
planning, as needed; and
f. Performing calculations or assessments regarding patient
treatments that may constitute a misadministration.
2. If the qualified medical physicist is not a full-time
employee of the registrant, the operating procedures required by subsection H
of this section shall also specifically address how the qualified medical
physicist is to be contacted for problems or emergencies, as well as the
specific actions, if any, to be taken until the qualified medical physicist can
be contacted.
H. Operating procedures.
1. Only individuals approved by the authorized user,
radiation safety officer, or qualified medical physicist shall be present in
the treatment room during treatment;
2. Electronic brachytherapy devices shall not be made
available for medical use unless the requirements of 12VAC5-481-3400 A and
subsections I and J of this section have been met;
3. The electronic brachytherapy device shall be inoperable,
either by hardware or password, when unattended by qualified staff or service
personnel;
4. During operation, the electronic brachytherapy device
operator shall monitor the position of all persons in the treatment room and
all persons entering the treatment room to prevent entering persons from
unshielded exposure from the treatment beam;
5. If a patient must be held in position during treatment,
mechanical supporting or restraining devices shall be used;
6. Written procedures shall be developed, implemented, and
maintained for responding to an abnormal situation. These procedures shall
include:
a. Instructions for responding to equipment failures and
the names of the individuals responsible for implementing corrective actions;
and
b. The names and telephone numbers of the authorized users,
the qualified medical physicist, and the radiation safety officer to be
contacted if the device or console operates abnormally;
7. A copy of the current operating and emergency procedures
shall be physically located at the electronic brachytherapy device control
console. If the control console is integral to the electronic brachytherapy
device, the required procedures shall be kept where the operator is located
during electronic brachytherapy device operation;
8. Instructions shall be posted at the electronic
brachytherapy device control console to inform the operator of the names and
telephone numbers of the authorized users, the qualified medical physicist, and
the radiation safety officer to be contacted if the device or console operates
abnormally; and
9. The radiation safety officer, or his designee, and an
authorized user shall be notified as soon as possible if the patient has a
medical emergency, suffers injury, or dies. The radiation safety officer or the
qualified medical physicist shall inform the manufacturer of the event.
I. Safety precautions for electronic brachytherapy
devices.
1. A qualified medical physicist shall determine which
persons in the treatment room require monitoring when the beam is energized;
2. An authorized user and a qualified medical physicist
shall be physically present during the initiation of all patient treatments
involving the electronic brachytherapy device;
3. A qualified medical physicist and either an authorized
user or a nonauthorized user (physician or electronic brachytherapy device
operator) under the supervision of an authorized user, who has been trained in
the operation and emergency response for the electronic brachytherapy device,
shall be physically present during continuation of all patient treatments
involving the electronic brachytherapy device;
4. When shielding is required by subdivision C 4 of this
section, the electronic brachytherapy device operator shall use a survey meter
to verify proper placement of the shielding immediately upon initiation of
treatment. Alternatively, a qualified medical physicist shall designate shield
locations sufficient to meet the requirements of 12VAC5-481-640 for any
individual, other than the patient, in the treatment room; and
5. All personnel in the treatment room shall remain behind
shielding during treatment. A qualified medical physicist shall approve any
deviation from this requirement and shall designate alternative radiation safety
protocols, compatible with patient safety, to provide an equivalent degree of
protection.
J. Electronic brachytherapy source calibration
measurements.
1. Calibration of the electronic brachytherapy source
output for an electronic brachytherapy device subject to this section shall be
performed by or under the direct supervision of a qualified medical physicist;
2. Calibration of the electronic brachytherapy source
output shall be made for each electronic brachytherapy source after any repair
affecting the x-ray beam generation, or when indicated by the electronic
brachytherapy source quality assurance checks;
3. Calibration of the electronic brachytherapy source
output shall utilize a dosimetry system described in 12VAC5-481-3400 C;
4. Calibration of the electronic brachytherapy source
output shall include, as applicable, determination of:
a. The output within 2.0% of the expected value, if
applicable, or determination of the output if there is no expected value;
b. Timer accuracy and linearity over the typical range of
use;
c. Proper operation of back-up exposure control devices;
d. Evaluation that the relative dose distribution about the
source is within 5.0% of that expected; and
e. Source positioning accuracy to within one millimeter
within the applicator;
5. Calibration of the x-ray source output required by
subdivisions 1 through 4 of this subsection shall be in accordance with current
published recommendations from a recognized national professional association
with expertise in electronic brachytherapy, when available. In the absence of a
calibration protocol published by a national professional association, the
manufacturer's calibration protocol shall be followed; and
6. The registrant shall maintain a record of each
calibration in an auditable form for the duration of the registration. The
record shall include the date of the calibration; the manufacturer's name,
model number, and serial number for the electronic brachytherapy device and a
unique identifier for its electronic brachytherapy source; the model numbers
and serial numbers of the instrument used to calibrate the electronic
brachytherapy device; and the name and signature of the qualified medical
physicist responsible for performing the calibration.
K. Periodic and day-of-use quality assurance checks for
electronic brachytherapy devices.
1. Quality assurance checks shall be performed on each
electronic brachytherapy device:
a. At the beginning of each day of use;
b. Each time the device is moved to a new room or each day
of use at each operating location for a self-contained electronic brachytherapy
unit transported in a van or trailer; and
c. After each x-ray tube installation.
2. The registrant shall perform periodic quality assurance
checks required by subdivision 1 of this subsection in accordance with
procedures established by the qualified medical physicist.
3. To satisfy the requirements of subdivision 1 of this
subsection, radiation output quality assurance checks shall include at a
minimum:
a. Verification that output of the electronic brachytherapy
source falls within 3.0% of expected values, as appropriate for the device, as
determined by:
(1) Output as a function of time, or
(2) Output as a function of setting on a monitor chamber.
b. Verification of the consistency of the dose distribution
to within 3.0% of that found during calibration required by subsection J of
this section; and
c. Validation of the operation of positioning methods to
ensure that the treatment dose exposes the intended location within one
millimeter.
4. The registrant shall use a dosimetry system that has
been intercompared within the previous 12 months with the dosimetry system
described in 12VAC5-481-3400 C 1 to make the quality assurance checks required
in subdivision 3 of this subsection.
5. The registrant shall review the results of each
radiation output quality assurance check according to the following procedures:
a. An authorized user and qualified medical physicist shall
be immediately notified if any parameter is not within its acceptable
tolerance. The electronic brachytherapy device shall not be made available for
subsequent medical use until the qualified medical physicist has determined
that all parameters are within the acceptable tolerances;
b. If all radiation output quality assurance check parameters
appear to be within the acceptable range, the quality assurance check shall be
reviewed and signed by either the authorized user or qualified medical
physicist within two days; and
c. The qualified medical physicist shall review and sign
the results of each radiation output quality assurance check at intervals not
to exceed 30 days.
6. To satisfy the requirements of subdivision 1 of this
subsection, safety device quality assurance checks shall, at a minimum, assure:
a. Proper operation of radiation exposure indicator lights
on the electronic brachytherapy device and on the control console;
b. Proper operation of viewing and intercom systems in each
electronic brachytherapy facility, if applicable;
c. Proper operation of radiation monitors, if applicable;
d. The integrity of all cables, catheters, or parts of the
device that carry high voltages; and
e. Connecting guide tubes, transfer tubes,
transfer-tube-applicator interfaces, and treatment spacers are free from any
defects that interfere with proper operation.
7. If the results of the safety device quality assurance
checks required in subdivision 6 of this subsection indicate the malfunction of
any system, a registrant shall secure the control console in the
"OFF" position and not use the electronic brachytherapy device except
as may be necessary to repair, replace, or check the malfunctioning system.
8. The registrant shall maintain a record of each quality
assurance check required by subdivisions 3 and 7 of this subsection in an
auditable form for three years.
a. The record shall include the date of the quality
assurance check; the manufacturer's name, model number, and serial number for
the electronic brachytherapy device; the name and signature of the individual
who performed the periodic quality assurance check; and the name and signature
of the qualified medical physicist who reviewed the quality assurance check;
and
b. For radiation output quality assurance checks required
by subdivision 3 of this subsection, the record shall also include the unique
identifier for the electronic brachytherapy source and the manufacturer's name,
model number, and serial number for the instrument used to measure the
radiation output of the electronic brachytherapy device.
L. Therapy-related computer systems. The registrant shall
perform acceptance testing on the treatment planning system of electronic
brachytherapy-related computer systems in accordance with current published
recommendations from a recognized national professional association with
expertise in electronic brachytherapy, when available. In the absence of an
acceptance testing protocol published by a national professional association,
the manufacturer's acceptance testing protocol shall be followed.
1. Acceptance testing shall be performed by or under the
direct supervision of a qualified medical physicist. At a minimum, the
acceptance testing shall include, as applicable, verification of:
a. The source-specific input parameters required by the
dose calculation algorithm;
b. The accuracy of dose, dwell time, and treatment time
calculations at representative points;
c. The accuracy of isodose plots and graphic displays;
d. The accuracy of the software used to determine radiation
source positions from radiographic images; and
e. If the treatment-planning system is different from the
treatment-delivery system, the accuracy of electronic transfer of the treatment
delivery parameters to the treatment delivery unit from the treatment planning
system.
2. The position indicators in the applicator shall be
compared to the actual position of the source or planned dwell positions, as
appropriate, at the time of commissioning.
3. Prior to each patient treatment regimen, the parameters
for the treatment shall be evaluated and approved by the authorized user and
the qualified medical physicist for correctness through means independent of
that used for the determination of the parameters.
M. Training.
1. A registrant shall provide instruction, initially and at
least annually, to all individuals who operate the electronic brachytherapy
device, as appropriate to the individual's assigned duties, in the operating
procedures identified in subsection H of this section. If the interval between
patients exceeds one year, retraining of the individuals shall be provided.
2. In addition to the requirements of 12VAC5-481-3390 C for
therapeutic radiation machine authorized users and 12VAC5-481-3390 D for
qualified medical physicists, the therapeutic radiation machine authorized
users and qualified medical physicists shall also receive device-specific
instruction initially from the manufacturer and annually from either the
manufacturer or other qualified trainer. The training shall be of a duration
recommended by a recognized national professional association with expertise in
electronic brachytherapy, when available. In the absence of any training
protocol recommended by a national professional association, the manufacturer's
training protocol shall be followed. The training shall include, but not be
limited to:
a. Device-specific radiation safety requirements;
b. Device operation;
c. Clinical use for the types of use approved by the U.S.
Food and Drug Administration;
d. Emergency procedures, including an emergency drill; and
e. The registrant's quality assurance program.
3. A registrant shall retain a record of individuals
receiving instruction required by subdivisions 1 and 2 of this subsection for
three years. The record shall include a list of the topics covered, the date of
the instruction, the names of the attendees, and the names of the individuals
who provided the instruction.
N. Mobile electronic brachytherapy service. A registrant
providing mobile electronic brachytherapy service shall, at a minimum:
1. Check all survey instruments before medical use at each
address of use or on each day of use, whichever is more restrictive.
2. Account for the electronic brachytherapy source in the
electronic brachytherapy device before departure from the client's address.
3. Perform at each location on each day of use all of the
required quality assurance checks specified in subsection K of this section to
assure proper operation of the device.
12VAC5-481-3453. Other use of electronically produced
radiation to deliver therapeutic radiation dosage.
A person shall not utilize any device that is designed to
electronically generate a source of ionizing radiation to deliver therapeutic
radiation dosage and that is not appropriately regulated under any existing
category of therapeutic radiation machine until:
1. The applicant or registrant has, at a minimum, provided
the agency with:
a. A detailed description of the device and its intended
application;
b. Facility design requirements, including shielding and
access control;
c. Documentation of appropriate training for authorized
user physicians and qualified medical physicists;
d. Methodology for measurement of dosages to be
administered to patients or human research subjects;
e. Documentation regarding calibration, maintenance, and
repair of the device, as well as instruments and equipment necessary for radiation
safety;
f. Radiation safety precautions and instructions; and
g. Other information requested by the agency in its review
of the application; and
2. The applicant or registrant has received written
approval from the agency to utilize the device in accordance with the
regulations and specific conditions the agency considers necessary for the
medical use of the device.
DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-481)
Dosimetry
of X-ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 keV
to 50 MeV: NCRP Report 69, 1981, National Council on Radiation Protection and
Measurements, 7910 Woodmont Avenue, Washington, DC 20014
Comprehensive
QA for Radiation Oncology: AAPM Report No. 46, 1994, American Association of
Physicists in Medicine, Committee Task Group 40, Radiation Therapy Committee,
published by the American Institute of Physics, One Physics Ellipse, College
Park, MD 20740-3846
AAPM
Code of Practice for Radiotherapy Accelerators: AAPM Report Number 47, 1994,
American Association of Physicists in Medicine Radiation Therapy Task Group 45,
published by the American Institute of Physics, One Physics Ellipse, College
Park, MD 20740-3846
Guidance
document on delivery, treatment planning, and clinical implementation of IMRT:
Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM
Report No. 82, Medical Physics, Vol. 30, No. 8, August 2003, American
Association of Physicists in Medicine
Quality
assurance for computed tomography simulators and the computed
tomography-simulation process: Report of the AAPM Radiation Therapy Committee
Task Group No. 66: AAPM Report No. 83, Medical Physics, Vol. 30, No. 10,
October 2003, American Association of Physicists in Medicine
VA.R. Doc. No. R16-4305; Filed March 25, 2016, 1:12 p.m.
TITLE 12. HEALTH
VA.R. Doc. No. R00-1; Filed March 18, 2016, 11:41 a.m.
TITLE 15. JUDICIAL
VA.R. Doc. No. R16-4610; Filed March 18, 2016, 3:05 p.m.
TITLE 15. JUDICIAL
VA.R. Doc. No. R16-3141; Filed March 18, 2016, 9:53 a.m.
TITLE 17. LIBRARIES AND CULTURAL RESOURCES
VA.R. Doc. No. R16-4259; Filed March 17, 2016, 2:54 p.m.
TITLE 17. LIBRARIES AND CULTURAL RESOURCES
VA.R. Doc. No. R16-4260; Filed March 17, 2016, 2:53 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
VA.R. Doc. No. R14-4029; Filed March 25, 2016, 1:02 p.m.
TITLE 22. SOCIAL SERVICES
VA.R. Doc. No. R14-3687; Filed March 29, 2016, 11:40 a.m.