GB 9706.255—2022标准修订要点解析  

Key points analysis for GB 9706.255-2022 revision

作　　者：马小建 王伟 张巍 胡知诿 MA Xiao-jian;WANG Wei;ZHANG Wei;HU Zhi-wei(Shenzhen Mindray Bio-medical Electronics Co.,Ltd.,Shenzhen 518057,Guangdong Province,China;Shanghai Testing and Inspection Institute for Medical Devices,Shanghai 201318,China)

机构地区：[1]深圳迈瑞生物医疗电子股份有限公司,广东深圳518057 [2]上海市医疗器械检验研究院,上海201318

出　　处：《医疗卫生装备》2023年第11期79-82,共4页Chinese Medical Equipment Journal

摘　　要：介绍了GB 9706.255—2022《医用电气设备第2-55部分:呼吸气体监护仪的基本安全和基本性能专用要求》修订的背景及范围,从整体上对比了GB 9706.255—2022和YY 0601—2009《医用电气设备呼吸气体监护仪的基本安全和主要性能专用要求》的差异,并对基本性能、标识标记和文件、防护等级、校准/校零、粗鲁搬运、功能性连接、可用性等具体修订要点进行了解读,可为生产企业和检验技术人员正确理解标准提供参考。The background and scope of the revision of GB 9706.255—2022"Medical Electrical Equipment—Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors"were introduced.The differences between GB 9706.255—2022 and YY 0601—2009"Medical electrical equipment particular requirements for basic safety and essential performance of respiratory gas monitors"were summarized.The key points of the revision of GB 9706.255—2022 were interpreted in terms of basic performance,marking signs and documents,protection level,calibration/nulling,rough handling,functional connectivity and usability.References were provided for manufacturers and inspection technicians to correctly understand GB 9706.255—2022.

关 键 词：GB 9706.255—2022 YY 0601—2009 标准修订 医用电气设备 呼吸气体监护仪 

分 类 号：R197.39[医药卫生—卫生事业管理]