6 Colo. Code Regs. § 1007-1-24.2

Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-24.2 - Definitions

As used in Part 24, these terms have the definitions set forth below.

"AAPM Report 46" means "Comprehensive QA for Radiation Oncology", AAPM Report No. 46 by Task Group 40 of the Radiation Therapy Committee of the American Association of Physicists in Medicine (Medical Physics, Vol. 21, Issue 4, April 1994, pp. 581-618).

"AAPM Report 47" means "AAPM Code of Practice for Radiotherapy Accelerators", AAPM Report No. 47 by Task Group 45 of the Radiation Therapy Committee of the American Association of Physicists in Medicine (Medical Physics, Vol. 21, Issue 7, July 1994, pp. 1093-1121).

"AAPM Report 82" means "Guidance Document on Delivery, Treatment Planning, and Clinical Implementation of IMRT", AAPM Report No. 82 by the IMRT Subcommittee of the Radiation Therapy Committee of the American Association of Physicists in Medicine (Medical Physics, Vol. 30, Issue 8, August 2003, pp. 2089-2115).

"AAPM Report 83" means "Quality Assurance for Computed-Tomography Simulators and the Computed Tomography-Simulation Process", AAPM Report No. 83 by Task Group 66 of the Radiation Therapy Committee of the American Association of Physicists in Medicine (Medical Physics, Vol. 30, Issue 10, October 2003, pp. 2762-2792).

"AAPM Task Group 101 Report" means "Stereotactic Body Radiation Therapy: The report of AAPM Task Group 101", AAPM Report by Task Group 101 of the Treatment Delivery Subcommittee, of the American Association of Physicists in Medicine (Medical Physics, Vol. 37, Issue 8, August 2010, pp. 4078-4101).

"AAPM Task Group 142 Report" means "Quality Assurance of Medical Accelerators", AAPM Report by Task Group 142 of the Quality Assurance and Outcome Improvement Subcommittee of the American Association of Physicists in Medicine (Medical Physics, Vol. 36, Issue 9, September 2009, pp. 4197-4212), International Standard Book Number 9781888340884.

"AAPM Task Group 179 Report" means "Quality Assurance for Image-guided Radiation Therapy Utilizing CT-based Technologies", a report of the AAPM Task Group 179, (Medical Physics, Vol. 39, Issue 4, April 2012, pp. 1946-1963), International Standard Book Number 9781936366156.

"ADCL" means a dosimetry calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM).

"Added filtration" means addition of a filter to the inherent filtration.

"Authorized user" means an individual who meets the requirements of Part 2, Appendix 2K.

"Barrier". See "protective barrier".

"Beam axis" means, for purposes of Part 24, the axis of rotation of the beam-limiting device.

"Beam limiting device" means a field-defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the 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 spread out a beam of electrons to provide a more uniform electron distribution in the useful beam.

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

"Central axis" means "beam axis".

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

"Collimator" means, for purposes of Part 24, a physical device that constrains the ionizing radiation.

"Contact therapy system" means a therapeutic radiation machine in which an external source of radiation is a short target to skin distance (TSD), usually less than five centimeters, from the skin. Such systems are not designed for intracavitary, intraluminal or interstitial use.

"Detector". See "radiation detector".

"Direct supervision". See Part 1 definition.

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

"Electronic brachytherapy device" means the components of an electronic brachytherapy system that produce and deliver therapeutic radiation, including the x-ray tube, control mechanism, cooling system, and the power source.

"Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.

"Electronic brachytherapy system" means a therapeutic radiation machine in which an x-ray source is used to irradiate tissue by intracavitary, intraluminal, interstitial, or similar application with the source in contact with, very close to, or at a distance usually less than five centimeters from the target volume

"External beam radiation therapy system" means a therapeutic radiation machine in which the source of radiation is a certain distance, usually more than five centimeters, from the body.

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

"Filter" means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to 24.7.

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

"General supervision". See Part 1 definition.

"Half-value layer" (HVL) means the thickness of a specified material needed to reduce a radiation beam to one-half of its original intensity.

"Image Guided Radiation Therapy" (IGRT) is the process which uses ionizing radiation for frequent two or three-dimensional imaging during a course of radiation treatment, to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan.

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

"Intensity Modulated Radiation Therapy" (IMRT) means radiation therapy using highly modulated spatially non-uniform radiation beam intensities that have been determined by 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.

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

"Irradiation" means the exposure of a living being or matter to ionizing radiation.

"Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry and collimator move through their full range of motion.

"Lead equivalent" means the thickness of a material that provides the same attenuation, under specified conditions, as lead.

"Leakage radiation" means the portion of ionizing radiation originating from the radiation therapy system that is not part of the useful beam. See "useful beam".

"Light field" means the area illuminated by light, simulating the radiation field.

"Misadministration". See "reportable medical event".

"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.

"Monitor unit" (MU). See "dose monitor unit".

"Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, while the beam is activated or with any planned change of absorbed dose distribution. It includes, but is not limited to, arc, skip, conformal, and rotational therapy.

"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 distance from the virtual source or target-to-isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.

"Operator" means a person who, by virtue of training and experience is authorized by the registrant or authorized user, to operate a therapeutic radiation machine:

(1) for human use, and who meets the requirements of 24.3.5.1; or
(2) for veterinary use, and who meets the requirements of 24.3.5.2.

"Patient", for purposes of Part 24, means a human individual or animal to whom machine-produced radiation is delivered for medical therapy.

"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 performed periodically to ensure that a previous parameter, condition, or function continues to be valid.

"Personal supervision". See Part 1 definition.

"Prescribed dose" means the total dose and dose per fraction intended to a particular point or volume as documented in the written directive.

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

"Primary protective barrier" (see "protective barrier").

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

(1) "Primary protective barrier", which means the material, excluding filters, placed in the useful beam;
(2) "Secondary protective barrier", which means the material that attenuates stray radiation.

"Registered medical physicist" (RMP) for radiation therapy means an individual who meets the applicable requirements of Part 2, Appendix 2B and has current Department approval to perform medical physics activities as a registered qualified expert for radiation therapy, including to design shielding, measure ionizing radiation, and oversee radiation protection and quality assurance at radiation therapy and other medical facilities.

"Radiation detector" means a device that in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

"Radiation field". See "useful beam".

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

"Radiation therapist" means an individual who meets the requirements of Part 2, Appendix 2L.

"Radiation therapy" means the therapeutic application of ionizing radiation to humans or animals for medical, research, or veterinary purposes.

"Radiation therapy physician" means a physician trained to use therapeutic radiation machines on humans.

"Radiation therapy veterinarian" means a veterinarian trained to use therapeutic radiation machines on animals.

"Radiotherapy". See "radiation therapy".

"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 pre-selected number of dose monitor units.

"Reportable medical event" means an event that meets the criteria in 24.6. For purposes of Part 24, "misadministration" is an equivalent term.

"Scattered primary radiation" means radiation that has been deviated in direction only by materials irradiated by the useful beam.

"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.

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

"Secondary protective barrier". See "protective barrier".

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

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

"Simulator" (radiation therapy simulation system) means:

(1) Any radiographic/fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and establishing and reproducing the position and size of the therapeutic irradiation field; or
(2) A computed tomography system, which is used in conjunction with relevant software that recreates the treatment machine, and which allows import, manipulation, display and storage of images from computed tomography and/or other imaging modalities.

"Source-skin distance" (SSD). See "target-skin distance".

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

"Stereotactic body radiation therapy (SBRT)" means a specialized form of radiation therapy of the body (other than intracranial or spinal lesions) which uses a known three dimensional reference system to localize and deliver high doses of radiation to a target lesion with high precision in large fraction sizes over a short course (typically 5 or fewer fractions) of treatment.

"Stereotactic radiosurgery (SRS)" means a specialized form of radiation therapy of the brain and spine, and which uses a known three dimensional reference system to localize and deliver high doses of radiation to a target lesion with high precision in large fraction sizes over a short course of treatment.

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

"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" (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 the nominal position of the electron source to the surface of the irradiated object or patient.

"Tenth-value layer" (TVL) means the thickness of a specified material which 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 at the same point without the material.

"Termination of irradiation" means the stopping of irradiation in a manner that will not permit continuance of irradiation without the resetting the operating condition(s) at the control panel.

"Therapeutic radiation machine" means x-ray or electron-producing equipment designed and used for radiation therapy, including external beam and electronic brachytherapy systems.

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

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

"Useful beam" means the portion of ionizing radiation originating from the radiation head of the therapy system intended for therapeutic purposes. See "leakage radiation".

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

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

"Written directive" means an order in writing for the administration of radiation to a specific human patient or human research subject, in accord with the requirements of 24.6.

"X-ray tube" means any electron tube that is designed to be used primarily for the production of x-rays.

6 CCR 1007-1-24.2

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022