新版GB 9706系列标准对检验工作影响的思考  

Thinking on the Effect of New Edition of GB 9706 Series Standards on Inspection Work

作　　者：周平[1,2] 任江涛 王志芳[2] 涂荣[3] ZHOU Ping;REN Jiangtao;WANG Zhifang;TU Rong(Bioengineering College of Chongqing University,Chongqing,China 400044;Chongqing Centre for Medical Device Control,Chongqing,China 400799;Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,Guangdong,China 510663)

机构地区：[1]重庆大学生物工程学院,重庆400044 [2]重庆医疗器械质量检验中心,重庆400799 [3]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国药业》2023年第20期38-41,共4页China Pharmaceuticals

基　　金：国家重点研发计划课题[2018YFC0117203]。

摘　　要：目的进一步提升我国医疗器械检验工作水平。方法结合检验用标准的必备特点,分析新、旧版GB 9706系列标准的特点,以及引入风险管理理念的新版GB 9706系列标准的发布实施对医用电气设备检验及监管的影响,并提出建议。结果与结论将新版GB 9706系列标准全文直接作为检验依据应用于检验,并将仅为企业内部受控的风险管理文档(变动系数较大)作为合规性核查依据,与国内检验机构目前的工作职责之间不兼容性较大。建议将已完善规范要素的产品技术要求作为检验依据。Objective To promote the inspection level of medical devices in China.Methods The characteristics of the new and old editions of GB 9706 series standards were analyzed based on the essential characteristics of inspection standards.The effects of the issue and implementation of the new edition of GB 9706 series standards introducing risk management concept on the inspection and supervision of medical electrical equipment were investigated,and the suggestions were put forward.Results and Conclusion The direct application of the whole new edition of GB 9706 series standards as the bases for inspection and the risk management documents(with large coefficient of variation)only controlled by intra-enterprises being as the conformance verification bases are highly incompatible with the current job responsibilities of domestic inspection institutes.It is suggested that the product technical requirements with improved normative elements should be used as the inspection bases.

关 键 词：风险管理 医用电气设备 医疗器械监管 检验依据 

分 类 号：R95[医药卫生—药学]