Fla. Admin. Code Ann. R. 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;
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;
(e) On-off errors;
(f) Trunnion centricity;
(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 404.022, 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.

New 2-11-10, 12-26-13.

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