GB 9706.1—2020医用电气设备修订要点与医疗器械监管应用分析  

Revisions of GB 9706.1-2020 Medical Electrical Equipment Revision Points and Medical Device Supervision Application Analysis

作　　者：李学洋 刘姗姗 李斌 李晶 于智睿 张寅豹 杨磊 LI Xue-Yang;LIU Shan-Shan;LI Bin;LI Jing;YU Zhi-Rui;ZHANG Yin-Bao;YANG Lei(Tianjin Customs,Tianjin 300457)

机构地区：[1]天津海关,天津300457

出　　处：《中国口岸科学技术》2023年第4期42-46,共5页China Port Science and Technology

基　　金：国家重点研发计划(2021YFF0602502)。

摘　　要：本研究基于GB 9706.1—2020《医用电气设备第1部分:基本安全和基本性能的通用要求》,结合GB9706.1—2007《医用电气设备第1部分:安全通用要求》标准,比对分析新旧国标的主要差异,探讨新增的风险管理、防护安全、基本性能等条款应用,以及新标准实施后对于医疗器械领域产品开展风险管理及监管建议。Based on the GB 9706.1-2020 Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential Performance and in comparison with GB 9706.1-2007 Medical Electrical Equipment-Part 1:General Requirements for Safety,this paper analyzed the main differences between the old and new national standards.It explored the application of newly added clauses on risk management,protective safety and basic performance,and provided suggestions on risk management and su-pervision of medical devices after the implementation of the new standards.

关 键 词：医用电气设备 安全通用要求 风险管理 防护安全 监管 

分 类 号：R955[医药卫生—药学]