新版GB9706.1-2020风险管理要求对企业质量体系的影响  

Effect on Manufacture’s Quality Management System by Risk Management Requirements in New Edition of GB 9706.1-2020

作　　者：段乔峰[1] 李欣 孙业 乔嘉琪 DUAN Qiao-feng;LI Xin;SUN Ye;QIAO Jia-qi(Tianjin Medical Devices Supervision and Testing Center,Tianjin 300384;Beijing Hua Guang Certification of Medical Devices Co.,Ltd.,Beijing 100011)

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384 [2]北京国医华光认证有限公司,北京100011

出　　处：《中国医疗器械信息》2022年第9期1-3,21,共4页China Medical Device Information

基　　金：国家重点研发计划资助(课题名称:中医诊疗设备国际标准研制,课题编号:2019YFC1712004)。

摘　　要：新版标准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》于2020年4月9日发布,并将于2023年5月1日正式执行。该标准相对于GB 9706.1-2007,无论从内容还是结构上都有了很大的变化,其中一个重要的变化就是引入了风险管理的要求,把评估设计过程充分性作为检验医用电气设备和系统对标准符合性的一种手段。文章简述医疗器械关于风险管理的法规要求及企业风险管理现状,同时对GB 9706.1-2020相关要求在企业质量管理体系的风险管理过程中的应用进行探讨,希望能对企业体系运行的完善及产品注册过程中的安全检验带来帮助。New edition of GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance issued on April 9,2020,and will be put into practice on May 1,2023.Comparing with GB 9706.1-2007,both contents and structure of the standard have been changed.One change is introduced that risk management process is required and assessing the adequacy of the design process is taken as a method of checking of the compliance with the standard.This paper briefly describes the requirements of national regulations and current situation about manufacture’s risk management process,and discusses some aspects of application of GB 9706.1-2020 risk management requirements in manufacture’s quality management system and risk management process.I hope this paper can provide some help for manufacture to running their quality system and to pass safety testing during registration process.

关 键 词：GB 9706.1-2020 YY/T 0316 风险管理 质量体系 医用电气设备 

分 类 号：R194[医药卫生—卫生事业管理]