OAR 333-123-0035
Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines

(1)

Full calibration, acceptance testing and commissioning of a therapeutic radiation machine subject to 333-123-0025 (Requirements for Therapeutic Radiation Machines) of this rule 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 contractual specifications. Acceptance testing and commissioning shall be conducted before the first medical use following installation or re-installation of the therapeutic radiation machine.

(3)

Full calibration must include all applicable parameters in accordance with industry standards of practice, carried out to determine that all parameters of the radiation therapy machine are within acceptable limits:

(a)

Before the first medical use after installation or reinstallation; and

(b)

Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi-energy and/or multi-mode capabilities must only require measurements for those modes and/or energies that are not within their acceptable range; and

(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/or energies, measurements must be performed on the effected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with periodic quality assurance check procedures against the criteria in 333-123-0040 (Quality Assurance And Safety Checks); and

(d)

At intervals not exceeding 1 year, 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 at intervals not exceeding 12 calendar months.

(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)

The calibration record must be maintained in an auditable form 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 therapeutic radiation machine;

(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.

Source: Rule 333-123-0035 — Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-123-0035.

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 333-123-0035’s source at or​.us