Scope

This Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic X-RAY EQUIPMENT to simulate physically a therapeutic RADIATION BEAM, so that the TREATMENT VOLUME to be irradiated during RADIOTHERAPY can be localized, and the position and size of the therapeutic RADIATION FIELD can be confirmed.

This Standard applies to RADIOTHERAPY SIMULATORS using HIGH-VOLTAGE GENE RATORS complying with CSA Standard CAN/CSA-C22.2 No. 601.2.7.

This Standard applies to RADIOTHERAPY SIMULATORS intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations.

This Standard applies to RADIOTHERAPY SIMULATORS comprising the following parts: (a) A system for producing a RADIATION BEAM not exceeding 400 kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM. (b) A system for producing images of the transmitted X-RAY BEAM, for example either by RADIOGRAPHY or by RADIOSCOPY. (c) An assembly to control the size of the RADIATION BEAM and to DELINEATE the intended treatment area. (d) A mechanical structure which physically simulates the geometry and motions of the RADIOTHERAPY EQUIPMENT and supports the imaging system. (e) A PATIENT SUPPORT system.

This Particular Standard applies to RADIOTHERAPY SIMULATORS, hereinafter referred to as EQUIPMENT, designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I.

The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment, Part 1: General Requirements for Safety, and its Supplement C22.2 No. 601.1S1 (adopted amendment 1 to IEC 601-1), hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard.

Canadian Deviations and Editorial Changes are included in this Standard.