Or. Admin. R. 333-123-0095

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-123-0095 - 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(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.

Or. Admin. R. 333-123-0095

PH 4-2013, f. & cert. ef. 1-29-13

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807