GB 9706.1—2020修订要点解读及对医用电气设备管理的启示  

Interpretation of main revision points of GB 9706.1—2020 and implications for management of medical electrical equipment

作　　者：徐恒[1] 许锋[1] XU Heng;XU Feng(Department of Biomedical Engineering,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学第三医院医学工程处,北京100191

出　　处：《医疗卫生装备》2021年第7期69-72,共4页Chinese Medical Equipment Journal

摘　　要：介绍了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》修订的背景及范围,从整体上对比了GB 9706.1—2020和GB 9706.1—2007《医用电气设备第1部分:安全通用要求》的差异,通过对风险管理、基本性能、预期使用寿命、安全防护等具体修订要点进行解读,针对性地提出了医用电气设备管理应加强设备预防性维护、定期开展设备质控、加强设备使用监管等建议,对完善医用电气设备的管理程序,利用好、监督好新标准的相关要求,保证医用电气设备的使用安全具有重要意义。GB 9706.1—2020"Medical electrical equipment—Part 1:General requirements for basic safety and essential performance"had its revision introduced in terms of the background and scope,then its difference was described from GB 9706.1—2007"Medical electrical equipment—Part 1:General requirements for safety".The main revision points were interpreted from the aspects of risk management,basic performance,expected service life,safety protection and etc.Some suggestions were put forward to enhance medical electrical equipment management including strengthening preventive maintenance,periodical quality control and use supervision,so as to improve the management procedures and use safety of medical electrical equipment based on the revised standard.[Chinese Medical Equipment Journal,2021,42(7):69-72]

关 键 词：GB 9706.1—2020 GB 9706.1—2007 IEC 60601-1:2012 医用电气设备 标准修订 

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