Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

Section 335.8190  Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units 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: A)        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; B)        Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and C)        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)         To satisfy the requirement of subsection (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)         A licensee shall use the dosimetry system described in Section 335.8080(a) of this Part to measure the output for one set of exposure conditions.  The remaining radiation measurements required in subsection (b)(1) of this Section may be made using a dosimetry system that indicates relative dose rates. d)         A licensee shall make full calibration measurements required by subsection (a) of this Section in accordance with published protocols accepted by nationally recognized bodies. e)         A licensee shall mathematically correct the outputs determined in subsection (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)         Full calibration measurements required by subsection (a) of this Section and physical decay corrections required by subsection (e) of this Section must be performed by the authorized medical physicist. g)         A licensee shall maintain a record of the gamma stereotactic radiosurgery unit full calibrations required by this Section for 5 years. h)         The record must include: 1)         The date of the calibration; 2)         The manufacturer's name, model and serial number of the gamma stereotactic radiosurgery units, the sources, and the instruments used to calibrate the units; 3)         The results and an assessment of the full calibrations; and 4)         The signature of the authorized medical physicist who performed the full calibration.