10 CFR 35.635, Full Calibration Measurements On Gamma Stereotactic Radiosurgery Units
Full calibration measurements on gamma stereotactic radiosurgery units
a
(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit--
- (1) Before the first medical use of the unit;
- (2) Before medical use under the following conditions--
- (i) 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;
- (ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and
- (iii) 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
- (3) 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.
b
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of--
- (1) The output within ±3 percent;
- (2) Relative helmet factors;
- (3) Isocenter coincidence;
- (4) Timer accuracy and linearity over the range of use;
- (5) On-off error;
- (6) Trunnion centricity;
- (7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
- (8) Helmet microswitches;
- (9) Emergency timing circuits; and
- (10) Stereotactic frames and localizing devices (trunnions).
c
(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
d
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.
e
(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.
f
(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.
g
(g) A licensee shall retain a record of each calibration in accordance with § 35.2632.
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