IEC 60601-1-2005 医用电气设备.第1部分:基本安全和基本性能的一般要求

标准号：IEC 60601-1-2005
中文标准名称：医用电气设备.第1部分:基本安全和基本性能的一般要求
英文标准名称：Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
标准类型：C39
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C39
国际标准分类号：11.040.01
引用标准：IEC 60065-2001;IEC 60068-2-2-1974;IEC 60079-0;IEC 60079-2;IEC 60079-5
适用范围：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELETRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS,hereafter referred to as ME EQUIPMENT and ME SYSTEMS.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only,or to ME SYSTEMS only, the title and content of that clause or subclause will say so.If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS,as relevant. HAZARDS inherent in teh intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirement in this standard except in 7.2.13 and 8.4.1.This standard can also be applied to equipment used for compensation or alleviation of desease,injury or disabiliby.In vitro diagnostic equipment that does not fall within the defintion fo ME EQUIPMENT is covered by the IEC 61010 series 2).This standard does not apply to the implantable parts of active implantable medical divices covered by ISO 14708-1 3).