This National Standard of Canada is based on International Standard IEC 601-2-11:1987. 1.1.1
This standard specifies requirements for the safety, design and construction of gamma beam equipment when used for RADIOTHERAPY in human medical practice. It lies within the scope of IEC Publication 601-1: Safety of Medical Electrical Equipment, Part 1: General Requirements, which applies to all medical electrical equipment. 1.1.2
This standard applies to equipment which is intended to deliver a GAMMA RADIATION BEAM(S) at NORMAL TREATMENT DISTANCES greater than 5 cm using a SEALED RADIOACTIVE SOURCE(S). For equipment operating at shorter distances,
special precautions may be necessary. 1.1.3
This standard specifies the requirements for equipment. It does not specify the requirements for the RADIATION SOURCES. 1.2 Object It is the purpose of the requirements contained in this standard to ensure that the proposed IRRADIATION conditions are met and the actual settings retained during IRRADIATION and that unintentional exposure to IRRADIATION of the PATIENT, operating personnel and the environment is kept as low as reasonably achievable. It is thus a prerequisite that: - this standard applies to equipment intended for use under the jurisdiction of a QUALIFIED PERSON; - maintenance of the equipment is performed at prescribed intervals; - and regular function checks be performed by the user. 1.2.1
In equipment of the type covered by this standard, ABSORBED DOSE is controlled by the time of IRRADIATION. Tolerances for the other methods of controlling the ABSORBED DOSE are under consideration. Such other methods are not included in this standard. This Particular Standard specifies requirements for GAMMA BEAM THERAPY EQUIPMENT 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 C22.2 No. CAN/CSA-601.1, Medical Electrical Equipment Part 1: General Requirements for Safety, 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. In this Particular Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation, or that which is advised but not mandatory.