Therapeutic Radiation Machines of Less than 500 kV

(A) Leakage Radiation. When the 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. 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) >50 and <500 kV Systems. The leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed one cGy (one 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 105 CMR 120.436(A)(1) and (2) 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% 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 can not be accidentally displaced at any possible tube orientation; (2) For equipment installed after July 9, 1999, an interlock system prevents irradiation if the proper filter is not in place; (3) The air kerma rate at a distance of one meter from the filter shall not exceed one cGy (one rad) per hour 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 tube shall be so mounted that it can not 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 which has 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 which 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 pre-selected 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) The timer and back-up timer if present shall be accurate to within 1% 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 105 CMR 120.436, 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) Means for indicating 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 July 9, 1999, a positive display of specific filter(s) in the beam. (J) Multiple Tubes. When a control panel is capable of energizing more than one x-ray tube: (1) It shall only be allowable to activate one X-ray tube at any time; (2) There shall be an indication at the control panel identifying which 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 output to the prescribed exposure parameters within five seconds after the 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 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 shielding adequate to meet requirements of 105 CMR 120.439, 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 which 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 inside the treatment room within a totally enclosed booth with protective barrier walls, door(s), ceiling and floor; (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 105 CMR 120.436(O)(3) is opened while the x-ray tube is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour. (P) Full Calibration Measurements. (1) Full calibration of a therapeutic radiation machine subject to 105 CMR 120.436 shall be performed by, or under the direct supervision of, a 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% 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 105 CMR 120.436(P)(1)(c): 1. 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 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 105 CMR 120.436(P)(1)(c)1. (2) To satisfy the requirement of 105 CMR 120.436(P)(1), full calibration shall include all measurements recommended for annual calibration by 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 tube, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the 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 105 CMR 120.436, which are capable of operation at greater than or equal to 50 kV. (2) To satisfy the requirement of 105 CMR 120.436(Q)(1), quality assurance checks shall meet the following requirements: (a) The registrant shall perform quality assurance checks in accordance with written procedures established by the 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 105 CMR 120.436(P)(1). They shall also state 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 105 CMR 120.436(P)(1), shall be stated. (3) The cause for a parameter exceeding a tolerance set by the 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 Qualified Medical Physicist's quality assurance check procedures, the system shall be recalibrated as required in 105 CMR 120.436(P)(1); (5) The registrant shall use the dosimetry system described in 105 CMR 120.434(C)(2) to make the quality assurance check required in 105 CMR 120.436(Q)(2); (6) The registrant shall have the Qualified Medical Physicist review and sign the results of each radiation output quality assurance check within 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 105 CMR 120.436 are performed at intervals not to exceed 30 days; (8) Notwithstanding the requirements of 105 CMR 120.436(Q)(6) and (7), the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 105 CMR 120.436(Q)(6) and (7) have been performed within one month period immediately prior to said administration; (9) To satisfy the requirement of 105 CMR 120.436(Q)(7), 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" and termination switches; (c) Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room; (d) Viewing systems; (e) If applicable, electrically operated treatment room doors activated from inside and outside the treatment room; (10) The registrant shall maintain a record of each quality assurance check required by 105 CMR 120.436(Q)(1) and (7) for three years. The record shall include the date of the quality assurance check, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number of the instrument(s) 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 and until the requirements of 105 CMR 120.436(P) and (Q) have been met; (2) Therapeutic radiation machines shall not be left unattended unless secured pursuant to 105 CMR 120.436(I)(5); (3) Mechanical supporting or restraining devices shall be used when a patient must be held in position for radiation therapy; (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 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 105 CMR 120.211. (S) Possession of Survey Instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 105 CMR 120.436 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 ten µSv (one mrem) per hour to ten mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with 105 CMR 120.438.