標準號：IEC 60601-1-2005
中文標準名稱：醫用電氣設備.第1部分:基本安全和基本性能的一般要求
英文標準名稱：Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
標準類型：C39
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C39
國際標準分類號：11.040.01
引用標準：IEC 60065-2001;IEC 60068-2-2-1974;IEC 60079-0;IEC 60079-2;IEC 60079-5
適用范圍：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).