Section 64E-5.6412 - Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each gamma stereotactic radiosurgery: (a) Before the first medical use of the unit;(b)1. Before medical use whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;2. Before medical use following replacement of the source or following reinstallation of the gamma stereotactic radiosurgery unit in a new location;3. Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and(c) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.(2) Full calibration measurements of the gamma stereotactic radiosurgery unit shall include the determination of:(a) The output within 3 percent;(b) Relative helmet factors;(c) Isocenter coincidence;(d) Timer constancy and linearity over the range of use;(g) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;(h) Helmet microswitches;(i) Emergency timing circuits; and(j) Stereotactic frames and localizing devices (trunnions).(3) A licensee shall use the dosimetry system described in Rule 64E-5.640, F.A.C., to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph 64E-5.6412(2)(a), F.A.C., may be made using a dosimetry system that indicates relative dose rates.(4) A licensee shall make full calibration measurements required by subsection 64E-5.6412(1), F.A.C., in accordance with published protocols accepted by nationally recognized bodies.(5) A licensee shall correct mathematically the outputs determined in paragraph 64E-5.6412(2)(a), F.A.C., at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.(6) Full calibration measurements required by subsection 64E-5.6412(1), F.A.C., and physical decay corrections required by subsection 64E-5.6412(5), F.A.C., shall be performed by the authorized medical physicist.(7) A licensee shall maintain a record of each gamma stereotactic radiosurgery unit calibration for three years. The record shall include:(a) The date of the calibration;(b) The manufacturer's name, model number, and serial number for both the gamma stereotactic radiosurgery unit and the source;(c) The model numbers and serial numbers of the instruments used to calibrate the gamma stereotactic radiosurgery unit;(d) The results and an assessment of the full calibrations; and(e) The signature of the authorized medical physicist.Fla. Admin. Code Ann. R. 64E-5.6412
Rulemaking Authority 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.