摘要
随着医用电气设备安全通用标准GB 9706.1-2020在国内的发布和即将实施,高频手术设备相关的专用安全标准IEC 60601-2-2最新版本第6.0版标准在国内的转化也即将提上日程。现结合高频手术设备的实际特性,解读IEC 60601-2-2第6.0版与GB 9706.4-2009(等同采用IEC 60601-2-2第4.0版)在条款内容上的差异,以期有助于加深对标准的理解,保障该标准的顺利转化及实施。
With the release and implementation of the general safety standard for medical electrical equipment GB 9706.1-2020,the latest version of IEC 60601-2-2,version 6.0 of the particular requirements for high-frequency surgical equipment,will be put on the agenda in China.Combining with the actual characteristics of high-frequency surgical equipment,this paper interprets the differences between IEC 60601-2-2 version 6.0 and GB 9706.4-2009(version 4.0)in terms of content,hoping to help deepen the understanding of the standard and ensure the smooth transformation and implementation of the standard.
作者
官辉
赖玉菡
李娟
GUAN Hui;LAI Yu-han;LI Juan(Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices),Sichuan Chengdu 611731)
出处
《中国医疗器械信息》
2021年第13期7-9,43,共4页
China Medical Device Information
