CAN/CSA-C22.2 No.601.2.12-1994(R1999)

Medical electrical equipment - Part 2: Particular requirements for the safety of lung ventilators for medical use


 

 

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标准号
CAN/CSA-C22.2 No.601.2.12-1994(R1999)
发布
1994年
发布单位
SCC
当前最新
CAN/CSA-C22.2 No.601.2.12-1994(R1999)
 
 
代替标准
1999-11-01
被代替标准
CAN/CSA-C22.2 No. 60601-2-12:03
适用范围
This National Standard of Canada is based on International Standard IEC 601-2-12:1988. 1 Scope This Particular Standard specifies safety requirements for LUNG VENTILATORS incorporating electrical devices designed for medical use. Additional non-electrical requirements, including some safety requirements, are given in ISO 5369 - 1977: Breathing machines for medical use - Lung ventilators. Safety requireme nts for LUNG VENTILATORS specified for use with inhalation anaesthetic agents are not included in this Particular Standard. For such equipment the IEC Publication 601- 2-13 Particular requirements for the safety of anaesthetic machines, (in preparation), applies. This Particular Standard specifies safety requirements for LUNG VENTILATORS 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 t hose 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 LUNG VENTILATORS covered within the scope of this Particular Standard, the LUNG VENTILATORS must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard. Replacement: ISO 5369 has been replaced by ISO 10651-1. Canadian Deviations and Editorial Changes are included in this Standard.

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