OAR 333-123-0145
Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning


(1) Full calibration, acceptance testing and commissioning must be performed by, or under the direct supervision of a qualified medical physicist.
(2) Acceptance testing and commissioning shall be performed in accordance with industry standards of practice and the manufacturer’s specifications. Acceptance testing and commissioning shall be conducted before the first patient treatment following installation or re-installation of the superficial electronic brachytherapy device.
(3) Full calibration must include all applicable parameters in accordance with industry standards of practice and implement all of the manufacturer’s specifications to determine that all parameters of the superficial brachytherapy device are within acceptable limits. Full calibration must be completed:
(a) Before the first medical use after installation or reinstallation;
(b) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be reconciled. Superficial brachytherapy device with multi-energy or multi-mode capabilities must only require measurements for those modes or energies that are not within their acceptable range;
(c) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and energies, measurements must be performed on the effected mode and energy that is in most frequent clinical use at the facility; (d) At intervals not exceeding 12 months, although it shall not be necessary to complete all elements of a full calibration at the same time, all applicable parameters (for all energies) shall be completed.
(4) The registrant must maintain a record of each full calibration for the duration of the registration. The record must include:
(a) The date of the calibration;
(b) The manufacturer’s name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube;
(c) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and
(d) The signature of the qualified medical physicist responsible for performing the calibration.
(5) Calibration records must be maintained in accordance with OAR 333-100-0057 (Maintenance of Records) for the duration of the registration. The record must include:
(a) The date of the calibration;
(b) The manufacturer’s name, model number and serial number for the superficial brachytherapy device;
(c) The model numbers and serial numbers of the instruments used to calibrate the superficial brachytherapy device; and
(d) The signature of the qualified medical physicist responsible for performing or overseeing the calibration.

Source: Rule 333-123-0145 — Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-123-0145.

333‑123‑0001
Purpose and Scope
333‑123‑0005
Definitions
333‑123‑0010
General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines
333‑123‑0015
Training and Qualification Requirements for Individuals in the External Beam Radiation Therapy Area
333‑123‑0020
Reports and Notifications of Unplanned Medical Treatment
333‑123‑0025
Requirements for Therapeutic Radiation Machines
333‑123‑0030
Facility Design Requirements for Therapeutic Radiation Machines
333‑123‑0035
Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines
333‑123‑0040
Quality Assurance And Safety Checks
333‑123‑0045
Quality Assurance Program
333‑123‑0050
Qualified Medical Physicist Support in Facilities Having Therapeutic Radiation Machines with Energies of 1 Mv and Above
333‑123‑0055
Electronic Brachytherapy
333‑123‑0060
Facility Design Requirements for Electronic Brachytherapy Devices
333‑123‑0065
Electrical Safety for Electronic Brachytherapy Devices
333‑123‑0070
Control Panel Functions
333‑123‑0075
Timer
333‑123‑0080
Medical Physicist
333‑123‑0085
Operating Procedures
333‑123‑0090
Safety Precautions for Electronic Brachytherapy Devices
333‑123‑0095
Electronic Brachytherapy Source Calibration Measurements
333‑123‑0100
Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices
333‑123‑0105
Therapy Related Computer Systems
333‑123‑0110
Training
333‑123‑0115
Mobile Electronic Brachytherapy Service
333‑123‑0120
Superficial Electronic Brachytherapy
333‑123‑0125
Superficial Electronic Brachytherapy Personnel Requirements
333‑123‑0130
Superficial Electronic Brachytherapy: Refresher Training
333‑123‑0135
Superficial Electronic Brachytherapy: Activation of the Superficial Electronic Brachytherapy X-ray Tube
333‑123‑0140
Superficial Electronic Brachytherapy: Facility Design Requirements
333‑123‑0145
Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning
333‑123‑0150
Superficial Electronic Brachytherapy: Quality Assurance Checks
333‑123‑0155
Superficial Electronic Brachytherapy: Operating Procedures
Last Updated

Jun. 8, 2021

Rule 333-123-0145’s source at or​.us