浅析IEC 60601-1:2005/AMD2:2020和IEC 60601-1:2005/AMD1:2012的主要差异  

Analysis of main differences between IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2005/AMD1:2012

作　　者：朱洪亮 ZHU Hong-liang(Shanghai Guoyan Medical Device Testing Center Co.,Ltd.,Shanghai 201201,China)

机构地区：[1]上海国研医疗器械检测中心有限公司,上海201201

出　　处：《医疗卫生装备》2024年第10期71-76,共6页Chinese Medical Equipment Journal

摘　　要：介绍了IEC 60601-1:2005/AMD2:2020的修订背景,从整体上比对了IEC 60601-1:2005/AMD2:2020与IEC60601-1:2005/AMD1:2012的主要差异,并对规范性引用文件、术语和定义,医用电气(medical electrical,ME)设备标识、标记和文件,ME设备防电击危险,ME设备危险情况和故障状态,锂蓄电池,ME系统中的保护接地连接等具体修订部分进行了解读,为有源医疗器械制造商和第三方检验检测机构的研发/测试人员正确理解IEC 60601-1:2005/AMD2:2020提供了参考。The background of the revision of IEC 60601-1:2005/AMD2:2020 was introduced,and IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2005/AMD1:2012 were compared roughly.The revision was explained in terms of normative referen-ces,terms and definitions,medical electrical(ME)equipment marking,labeling and documentation,ME equipment protec-tion against electric shock hazards,ME equipment hazardous conditions and fault states,lithium secondary batteries and pro-tective earthing connections in ME systems.References were provided for correct understanding of the IEC 60601-1:2005/AMD2:2020 by the active medical device manufacturers and third-party inspection and testing organizations'R&D/testing personnel.[Chinese Medical Equipment Journal,2024,45(10):71-76]

关 键 词：IEC 60601-1:2005/AMD2:2020 IEC 60601-1:2005/AMD1:2012 医用电气设备 标准解读 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]