Florida Regulations 64E-5.6411: Full Calibration Measurements on Remote Afterloader Units
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(1) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each remote afterloader unit:
(a) Before the first medical use of the unit;
(b)1. Before medical use following replacement of the source or following reinstallation of the unit in a new location outside the facility; and,
2. Before medical use following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and,
(c) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and,
(d) At intervals not exceeding 1 year for low dose-rate remote afterloader units.
(2) Full calibration measurements of remote afterloader unit shall include the determination of:
(a) The output within 5 percent;
(b) Source positioning accuracy to within 1 millimeter;
(c) Source retraction with backup battery upon power failure;
(d) Timer constancy and linearity over the range of use;
(e) Length of the source transfer tubes;
(f) Length of the applicators; and,
(g) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.
(3) A licensee shall use the dosimetry system described in Fl. Admin. Code R. 64E-5.640, to measure the output for one set of exposure conditions. The remaining radiation measurements required in Fl. Admin. Code R. 64E-5.6411(2)(a), may be made using a dosimetry system that indicates relative dose rates.
(4) A licensee shall make full calibration measurements required by subsection 64E-5.6411(1), F.A.C., in accordance with published protocols accepted by nationally recognized bodies.
(5) A licensee shall correct mathematically the outputs determined in Fl. Admin. Code R. 64E-5.6411(2)(a), for physical decay at intervals consistent with 1 percent physical decay.
(6) Full calibration measurements required by subsection 64E-5.6411(1), F.A.C., and physical decay corrections required by subsection 64E-5.6411(5), F.A.C., shall be performed by the authorized medical physicist.
(7) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subsection 64E-5.6411(2), F.A.C., a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.
(8) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with subsections 64E-5.6411(1)-(5), F.A.C.
(9) A licensee shall maintain a record of each remote afterloader unit calibration for three years. The record shall include the following:
(a) The date of the calibration;
(b) The manufacturer’s name, model number, and serial number for both the remote afterloader unit and the source;
(c) The model numbers and serial numbers of the instruments used to calibrate the remote afterloader unit;
(d) The results and an assessment of the full calibrations.
(e) The results of the autoradiograph required for low dose-rate remote afterloaders; and,
(f) The signature of the authorized medical physicist.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 2-11-10.
(b)1. Before medical use following replacement of the source or following reinstallation of the unit in a new location outside the facility; and,
2. Before medical use following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and,
(c) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and,
(d) At intervals not exceeding 1 year for low dose-rate remote afterloader units.
(2) Full calibration measurements of remote afterloader unit shall include the determination of:
(a) The output within 5 percent;
(b) Source positioning accuracy to within 1 millimeter;
(c) Source retraction with backup battery upon power failure;
(d) Timer constancy and linearity over the range of use;
(e) Length of the source transfer tubes;
(f) Length of the applicators; and,
(g) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.
(3) A licensee shall use the dosimetry system described in Fl. Admin. Code R. 64E-5.640, to measure the output for one set of exposure conditions. The remaining radiation measurements required in Fl. Admin. Code R. 64E-5.6411(2)(a), may be made using a dosimetry system that indicates relative dose rates.
(4) A licensee shall make full calibration measurements required by subsection 64E-5.6411(1), F.A.C., in accordance with published protocols accepted by nationally recognized bodies.
(5) A licensee shall correct mathematically the outputs determined in Fl. Admin. Code R. 64E-5.6411(2)(a), for physical decay at intervals consistent with 1 percent physical decay.
(6) Full calibration measurements required by subsection 64E-5.6411(1), F.A.C., and physical decay corrections required by subsection 64E-5.6411(5), F.A.C., shall be performed by the authorized medical physicist.
(7) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subsection 64E-5.6411(2), F.A.C., a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.
(8) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with subsections 64E-5.6411(1)-(5), F.A.C.
(9) A licensee shall maintain a record of each remote afterloader unit calibration for three years. The record shall include the following:
(a) The date of the calibration;
(b) The manufacturer’s name, model number, and serial number for both the remote afterloader unit and the source;
(c) The model numbers and serial numbers of the instruments used to calibrate the remote afterloader unit;
(d) The results and an assessment of the full calibrations.
(e) The results of the autoradiograph required for low dose-rate remote afterloaders; and,
(f) The signature of the authorized medical physicist.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 2-11-10.