| (a) Purpose. This section establishes radiation safety
requirements for the use of accelerators, therapeutic radiation machines,
radiation therapy simulation systems (simulators), and electronic
brachytherapy devices. No person shall possess, use, transfer, or
acquire an accelerator, a therapeutic radiation machine, a radiation
therapy simulation system (simulator), or electronic brachytherapy
device, except as authorized in a certificate of registration issued
in accordance with §289.226 of this title (relating to Registration
of Radiation Machine Use and Services) or as otherwise provided for
in this chapter.
(b) Scope.
(1) This section applies to persons who receive, possess,
use or transfer accelerators used in industrial operations and research
and development, and therapeutic radiation machines, radiation therapy
simulation systems (simulators), and electronic brachytherapy devices
used in the healing arts and veterinary medicine. Use of therapeutic
radiation machines in the healing arts or veterinary medicine under
this section shall be by or under the supervision of a physician of
the healing arts or a veterinarian. Use of electronic brachytherapy
devices under this section shall be by or under the supervision of
a certified physician. The registrant shall be responsible for the
administrative control and for directing the use of the accelerators,
other therapeutic radiation machines, simulators, or electronic brachytherapy
devices.
(2) The requirements of this section are in addition
to and not in substitution for other applicable requirements of §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning
and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.226
of this title, and §289.231 of this title (relating to General
Provisions and Standards for Protection Against Machine-Produced Radiation).
(3) Registrants engaged in industrial radiographic
operations are subject to the requirements of §289.255 of this
title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography).
(4) An entity that is a "covered entity" as that term
is defined in HIPAA, (the Health Insurance Portability and Accountability
Act of 1996, 45 Code of Federal Regulations, Parts 160 and 164) may
be subject to privacy standards governing how information that identifies
a patient can be used and disclosed. Failure to follow HIPAA requirements
may result in the department making a referral of a potential violation
to the United States Department of Health and Human Services.
(c) Prohibitions.
(1) The agency may prohibit use of accelerators, therapeutic
radiation machines, simulators, or electronic brachytherapy devices
that pose significant threat or endanger occupational and public health
and safety, in accordance with §289.205 of this title and §289.231
of this title.
(2) Individuals shall not be exposed to the useful
beam except for healing arts purposes and unless such exposure has
been authorized by a physician of the healing arts. For electronic
brachytherapy devices, individuals shall not be exposed to the useful
beam except for healing arts purposes and unless such exposure has
been authorized by a certified physician. This provision specifically
prohibits deliberate exposure of an individual for training, demonstration,
or other non-healing arts purposes.
(3) No research and/or development using radiation
machines on humans shall be conducted unless approved by an Institutional
Review Board (IRB) as required by Title 45, CFR Part 46 and Title
21, CFR Part 56. The IRB shall include at least one physician of the
healing arts to direct any use of radiation in accordance with §289.231(b)
of this title.
(d) Exemptions.
(1) Veterinary facilities are exempt from the aural
communication requirements for radiation therapy systems and radiation
therapy simulators in subsection (h)(2)(B)(i), (h)(3)(B)(v), or (h)(4)(A)(iv)
of this section.
(2) Individuals who are sole physicians, sole operators
and the only occupationally exposed individual are exempt from the
following requirements:
(A) §289.203(b) and (c) of this title; and
(B) subsection (h)(1)(G) of this section.
(e) Definitions. The following words and terms when
used in this section shall have the following meaning unless the context
clearly indicates otherwise.
(1) Absorbed dose (D)--The mean energy imparted by
ionizing radiation to matter. Absorbed dose is determined as the quotient
of dE by dM, where dE is the mean energy imparted by ionizing radiation
to matter of mass dM. The SI unit of absorbed dose is joule per kilogram
and the special name of the unit of absorbed dose is the gray (Gy).
The previously used special unit of absorbed dose (rad) is being replaced
by the gray.
(2) Absorbed dose rate--Absorbed dose per unit time,
for machines with timers, or dose monitor unit per unit time for linear
accelerators.
(3) Air kerma--The kinetic energy released in air by
ionizing radiation. Kerma is the quotient of dE by dM, where dE is
the sum of the initial kinetic energies of all the charged ionizing
particles liberated by uncharged ionizing particles in air of mass
dM. The SI unit of air kerma is joule per kilogram and the special
name for the unit of kerma is the gray (Gy).
(4) Barrier--(See definition for protective barrier).
(5) Beam axis--The axis of rotation of the beam limiting
device.
(6) Beam-flattening filter--(See field-flattening filter).
(7) Beam-limiting device--A field defining collimator,
integral to the therapeutic radiation machine, which provides a means
to restrict the dimensions of the useful beam.
(8) Beam monitoring system--A system designed and installed
in the radiation head to detect and measure the radiation present
in the useful beam.
(9) Beam quality--A term that describes the penetrating
power of the x-ray beam. This is identified numerically by half-value
layer and is influenced by kilovolt peak (kVp) and filtration.
(10) Beam quality (accelerator)--A term that describes
the type and penetrating power of the ionizing radiation produced
for certain machine settings.
(11) Beam scattering foil--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.
(12) Central axis of the beam--An imaginary line passing
through the center of the useful beam and the center of the plane
figure formed by the edge of the first beam-limiting device.
(13) Certified physician--A physician licensed by the
Texas Medical Board and certified in radiation oncology or therapeutic
radiology.
(14) Coefficient of variation or C--The ratio of the
standard deviation to the mean value of a population of observations.
It is estimated using the following equation:
Attached Graphic
(15) Collimator--A device or mechanism by which the
x-ray beam is restricted in size.
(16) Computed tomography (CT)--The production of a
tomogram by the acquisition and computer processing of x-ray transmission
data.
(17) Continuous pressure type switch--A switch so constructed
that a circuit closing contact can be maintained only by continuous
pressure on the switch by the operator.
(18) Control panel--The part of the radiation machine
where the switches, knobs, push buttons, and other hardware necessary
for manually setting the technique factors are located. For purposes
of this section console is an equivalent term.
(19) CT conditions of operation--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 this subsection.
(20) Detector--(See definition for radiation detector).
(21) Diaphragm--A device or mechanism by which the
x-ray beam is restricted in size.
(22) Dose monitor unit (DMU)--A unit response from
the beam monitoring system from which the absorbed dose can be calculated.
(23) Dosimetry system--A system of devices used for
the detection, measurement, and display of qualitative and quantitative
radiation exposures.
(24) Electronic brachytherapy--A method of radiation
therapy using electrically generated x-rays to deliver a radiation
dose at a distance of up to a few centimeters by intracavitary, intraluminal
or interstitial application, or by applications with the source in
contact with the body surface or very close to the body surface.
Cont'd... |
