Statutes, codes, and regulations
Colorado Administrative Code
Department 1000 - Department of AgricultureDivision 1007 - Plant Industry DivisionRule 6 CCR 1007-1 - RULES AND REGULATIONS PERTAINING TO THE ADMINISTRATION AND ENFORCEMENT OF THE PESTICIDE APPLICATORS' ACTPart 24 - RADIATION CONTROL - PARTICLE ACCELERATORS AND THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS
SPECIFIC REQUIREMENTS
Section 6 CCR 1007-1-24.7 - Therapeutic Radiation Machines of Less Than 500 kV

6 Colo. Code Regs. § 1007-1-24.7

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Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-24.7 - Therapeutic Radiation Machines of Less Than 500 kV
24.7.1 Leakage Radiation.
24.7.1.1 For each therapeutic radiation machine, the registrant shall determine for all systems the maximum leakage radiation at 5 centimeters from the tube housing assembly, and also at 1 meter from the target for systems > 50 to < 500 kV, or obtain equivalent measured and published data from the manufacturer or by other means acceptable to the Department.
24.7.1.2 When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate:
(1) For systems 5 to 50 kV, shall not exceed 1 mGy (100 mrad) in any one hour, measured at any position 5 centimeters from the tube housing assembly.
(2) For systems > 50 to < 500 kV, shall not exceed 1 cGy (1 rad) in any one hour, measured at a distance of 1 meter from the target in any direction.
(a) This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters.
(b) In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.
24.7.1.3 Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department.
24.7.2 Permanent Beam Limiting Devices.
24.7.2.1 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.
24.7.3 Adjustable or Removable Beam Limiting Devices.
24.7.3.1 All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five (5) percent of the useful beam for the most penetrating beam used.
24.7.3.2 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam, as applicable to the device as originally manufactured.
24.7.4 Filter System.
24.7.4.1 The filter system shall be so designed that:
(1) Filters cannot be accidentally displaced at any possible tube orientation;
(2) 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 1 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.
24.7.5 Tube Immobilization.
24.7.5.1 The x-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and
24.7.5.2 The tube housing assembly shall be capable of being immobilized for stationary portal treatments.
24.7.6 Source Marking.
24.7.6.1 The tube housing assembly shall be so marked that it is possible to determine the location of the source to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures.
24.7.7 Beam Block.
24.7.7.1 On contact therapy systems, a shield of at least 0.5 millimeters of lead equivalency at 100 kV shall be positioned over the entire useful beam exit port during periods when the tube is energized and the beam is not in use.
24.7.8 Timer.
24.7.8.1 A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.
24.7.8.2 The timer required by 24.7.8.1 shall:
(1) Have a display at the treatment control panel;
(2) Have a pre-set time selector and an elapsed time or time remaining indicator;
(3) 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;
(4) Terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
(5) Permit accurate pre-setting and determination of exposure times as short as one second;
(6) Not permit an exposure if set at zero;
(7) 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
(8) Be accurate to within one percent of the selected value or one second, whichever is greater.
24.7.9 Control Panel Functions.
24.7.9.1 The control panel, in addition to the displays required by other provisions in 24.7, shall have:
(1) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
(2) An indication of whether x-rays are being produced;
(3) A means for indicating x-ray tube potential and current;
(4) A 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 30, 1999, a positive display of specific filter(s) in the beam.
24.7.10 Multiple Tubes.
24.7.10.1 When a control panel may energize more than one x-ray tube:
(1) Only one x-ray tube shall activate at any time;
(2) The control panel shall have an indicator that identifies which x-ray tube is activated; and
(3) An indicator at the tube housing assembly shall identify when that tube is energized.
24.7.11 Target-Skin Distance (TSD).
24.7.11.1 Means shall be provided to determine the central axis TSD to within one centimeter and to reproduce this measurement to within 2 millimeters thereafter.
24.7.12 Shutters.
24.7.12.1 Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds after turning "ON" the x-ray switch to energize the x-ray tube, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly.
(1) In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel.
(2) An indication of shutter position shall appear at the control panel.
24.7.13 Low Filtration X-ray Tubes.
24.7.13.1 Each therapeutic radiation machine equipped with a beryllium or other low-filtration window (HVL < 0.1 mm of Al) 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.
24.7.14 Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating in the Range 50 kV to 500 kV.
24.7.14.1 In addition to shielding adequate to meet requirements of 24.4.5, the treatment room shall meet the following design requirements:
(1) Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel, except for an intraoperative radiotherapy (IORT) room where the patient is under general anesthesia and no staff remain in the room.
(2) Viewing Systems.
(a) 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.
(b) The viewing system shall be so located that the operator may observe the patient from the treatment control panel.
(b) The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.
24.7.15 Additional Requirements.
24.7.15.1 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;
(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 24.7.15.1(3) is opened while the x-ray tube is activated, the air kerma rate in the useful beam at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.
24.7.16 Full Calibration Measurements.
24.7.16.1 Full calibration of a therapeutic radiation machine subject to 24.7 shall be performed by, or under the personal supervision of, a Registered Medical Physicist:
(1) Before the first medical use following installation or reinstallation of the therapeutic radiation machine;
(2) At intervals not exceeding one year; and
(3) Before medical use under the following conditions:
(a) Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled; and
(b) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(4) Notwithstanding the requirements of 24.7.16.1(3):
(a) Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and
(b) 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 use in treatments at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in 24.7.16.1(3)(a).
24.7.16.2 To satisfy the requirement of 24.7.16.1, full calibration shall include all measurements recommended for annual calibration by AAPM Report 46, or AAPM Task Group 142 report unless the Registered Medical Physicist determines that a particular recommendation of these reports is not warranted for the clinical tasks for which the equipment will be used, or is not applicable to the type of therapy device in use. Deviations from these guidance documents shall be documented in the written procedures.
24.7.16.3 The registrant shall maintain a record of each calibration for the duration of the registration, to include:
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube;
(3) The manufacturer's name, model number and serial number for the instrument(s) used to calibrate the therapeutic radiation machine; and
(4) The signature of the Registered Medical Physicist performing or exercising personal supervision of the calibration.
24.7.17 Periodic Quality Assurance Checks.
24.7.17.1 Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to 24.7, which are capable of operation at greater than or equal to 50 kV.
24.7.17.2 To satisfy the requirement of 24.7.17.1, quality assurance checks shall meet the following requirements:
(1) The registrant shall perform quality assurance checks in accordance with written procedures established by the Registered Medical Physicist; and
(2) The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed.
(a) The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in 24.7.16.1.
(b) 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 24.7.16.1, shall be stated.
24.7.17.3 The cause for a parameter exceeding a tolerance set by the Registered Medical Physicist shall be investigated and corrected before the system is used for patient irradiation.
24.7.17.4 Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the Registered Medical Physicist's quality assurance check procedures, the system shall be recalibrated as required in 24.7.16.1.
24.7.17.5 The registrant shall use the dosimetry system described in 24.4.3 to make the quality assurance check required in 24.7.17.2.
24.7.17.6 The registrant shall have the Registered Medical Physicist review and sign the results of each radiation output quality assurance check within one month of the date that the check was performed.
24.7.17.7 The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to 24.7 are performed at intervals not to exceed one month.
24.7.17.8 Notwithstanding the requirements of 24.7.17.6 and 24.7.17.7, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 24.7.17.6 and 24.7.17.7 have been performed within the 30 day period immediately prior to said administration.
24.7.17.9 To satisfy the requirement of 24.7.17.7, safety quality assurance checks shall ensure proper operation of:
(1) Electrical interlocks at each radiation therapy room entrance;
(2) The "BEAM-ON" and termination switches;
(3) If applicable, beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;
(4) Viewing systems; and
(5) If applicable, electrically operated treatment room doors from inside and outside the treatment room.
24.7.17.10 The registrant shall maintain a record of each quality assurance check required by 24.7.17.1 and 24.7.17.7 for three (3) years, including:
(1) The date of the quality assurance check;
(2) The manufacturer's name, model number, and serial number of the therapeutic radiation machine;
(3) The manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and
(4) The signature of the individual who performed the periodic quality assurance check.
24.7.18 Operating Procedures.
24.7.18.1 The therapeutic radiation machine shall not be used for irradiation of a patient unless the requirements of 24.7.16 and 24.7.17 have been met;
24.7.18.2 Therapeutic radiation machines shall not be left unattended unless secured pursuant to 24.7.9.1(5);
24.7.18.3 When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;
24.7.18.4 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.
(1) In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;
24.7.18.5 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and
24.7.18.6 No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV.
24.7.18.7 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 4.6.

6 CCR 1007-1-24.7

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