Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment
This National Standard of Canada is based on International Standard IEC 601-2-17:1988. 1.1 Scope 1.1.1 This Particular Standard specifies requirements for the safety of remote-controlled automatically-driven EQUIPMENT for gamma-ray therapy of human subjects using AFTERLOADING. This Particular Standard applies to EQUIPMENT 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 and its supplement C22.2 No. 601.1S1, 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. 1.1.2 This Standard specifies requirements for AFTERLOADING EQUIPMENT - which contains and uses only gamma-ray SEALED RADIOACTIVE SOURCES,
- which automatically drives the gamma-ray SEALED RADIOACTIVE SOURCE(S) from a STORAGE CONTAINER to a treatment position inside the SOURCE APPLICATOR(S),
- which is designed for connection to a PATIENT, and
- with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either programmable electronic systems (computer or microprocessors) or non-programmable systems (see also note to Sub-clause 3.2). This Standard is not intended to apply to EQUIPMENT with neutron RADIOACTIVE SOURCES. 1.1.3 This Standard specifies requirements for EQUIPMENT which gives AIR KERMA RATES up to 500 mGy per hour at 1 m from the RADIOACTIVE SOURCES in use. For EQUIPMENT operating outside this range, special precautions may be necessary. 1.1.4 This Standard specifies requirements for EQUIPMENT intended to be - used under the supervision of QUALIFIED PERSONS,
- maintained at predetermined intervals,
- subject to regular checks by the USER, and
- used for particular specified clinical purposes, e.g. INTRACAVITARY, INTERSTITIAL or SUPERFICIAL RADIOTHERAPY. This Standard does not specify requirements for gamma-ray SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (see Sub-clause 6.8.3). 1.1.5 The requirements of this Standard are based on the assumption that: - an IRRADIATION TREATMENT PRESCRIPTION is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
- the AIR KERMA RATES at 1 m from the RADIOACTIVE SOURCES in the EQUIPMENT are known. This Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that: - the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
- GAMMA IRRADIATION is delivered from the selected RADIOACTIVE SOURCE configuration for the selected duration;
- GAMMA IRRADIATION is delivered by the EQUIPMENT without causing unnecessary risk to the OPERATOR or other persons in the immediate surroundings. Canadian Deviations and Editorial Changes are included in this Standard.