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RULE §289.229Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices

(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.

  (25) Electronic brachytherapy device--The system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.

  (26) Electronic brachytherapy source--The x-ray tube component used in an electronic brachytherapy device.

  (27) External beam radiation therapy--Therapeutic irradiation in which the source of radiation is at a distance from the body.

  (28) Field-flattening filter--A filter used to homogenize the absorbed dose rate over the radiation field.

  (29) Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source to image distance and defined by the intersection of the major axes and the 50% isodose line.

  (30) Filter--Material placed in the useful beam to change beam quality in therapeutic radiation machines subject to subsection (h) of this section.

  (31) Focal spot--The area projected on the anode of the x-ray tube that is bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

  (32) Gantry--That part of the radiation therapy system supporting and allowing possible movements of the radiation head about the center of rotation.

  (33) Gray (Gy)--For purposes of this section, the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. For purposes of this section the previous unit of absorbed dose (rad) is being replaced by the gray (1 Gy = 100 rad).

  (34) Half-value layer (HVL)--The thickness of a specified material which attenuates x-radiation or gamma radiation to an extent such that the exposure rate (air kerma rate), or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.

  (35) Healing arts--Any treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.

  (36) Image receptor--Any device, such as a fluorescent screen or radiographic film, 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.

  (37) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.

  (38) Interlock--A device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.

  (39) Interruption of irradiation--The stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

  (40) Irradiation--The exposure of a living being or matter to ionizing radiation.

  (41) Isocenter--The center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

  (42) Kilovolt (kV) (kilo electron volt (keV))--The energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. (Note: current convention is to use kV for photons and keV for electrons.)

  (43) Kilovolt peak--kVp (See definition for peak tube potential).

  (44) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.

  (45) Leakage radiation--Radiation emanating from the source(s) assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated.

  (46) Leakage technique factors--The technique factors associated with the source assembly that is used in measuring leakage radiation.

  (47) Licensed medical physicist--An individual holding a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, with a specialty in therapeutic radiological physics.

  (48) Light field--The area illuminated by light, simulating the radiation field.

  (49) mA--Milliampere.

  (50) Medical event--An event that meets the criteria specified in subsection (i) of this section.


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