Electronic Brachytherapy Source Calibration Measurements
(1)Calibration of the electronic brachytherapy source output for an electronic brachytherapy device shall be performed by, or under the direct supervision of a Qualified Medical Physicist.
(2)Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source annually, or after any repair affecting the X-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks.
(3)Calibration of the electronic brachytherapy source output shall utilize a calibration procedure in accordance with OAR 333-123-0010 (General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines)(5). The dosimetry system shall have been calibrated at the applicable electronic brachytherapy source energy.
(4)Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:
(a)The output within two percent of the expected value, if applicable, or determination of the output if there is no expected value;
(b)Timer accuracy and linearity over the typical range of use;
(c)Proper operation of back-up exposure control devices;
(d)Evaluation that relative dose distribution around the source is within the limit recommended by the manufacturer or recommendations from a recognized national professional association in electronic brachytherapy (when available); and
(e)Source positioning accuracy to within 1 mm within the applicator.
(5)Calibration of the X-ray source output shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer’s calibration protocol shall be followed.
(6)The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include:
(a)The date of the calibration;
(b)The manufacturer’s name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;
(c)The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and
(d)The name and signature of the Qualified Medical Physicist responsible for performing the calibration.
Rule 333-123-0095 — Electronic Brachytherapy Source Calibration Measurements,