GB9706.1-2020医用电气设备基本安全和基本性能的通用要求检测仪器设备分析  

Analysis of the Needed Test-Instrument in Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance GB9706.1-2020 Standard

作　　者：李学洋 张婧 张寅豹 刘姗姗 李晶 于智睿 LI Xue-yang;ZHANG Jing;ZHANG Yin-bao;LIU Shan-shan;LI Jing;YU Zhi-rui(Technical Center for Safety of Industrial Products of Tianjin Customs,Tianjin 300457)

机构地区：[1]天津海关工业产品安全技术中心,天津300457

出　　处：《中国医疗器械信息》2024年第3期22-24,168,共4页China Medical Device Information

摘　　要：针对GB9706.1-2020医用电气设备基本安全和基本性能的通用要求,按照标准条款按顺序归纳出具体测试项目,确定检测参数所需仪器设备,对照标准要求细化仪器设备技术参数及环境实施要求。有效解决将抽象的标准条款与具体检测测试及所用仪器设备相互结合转化的问题,为开展GB9706.1检测提供技术支持。Analysis of the medical electrical equipment general requirements for basic safety and essential performance GB9706.1-2020 standard.According to the terms of this standard,the specific test items are summed up in order,and the specific test instrument and equipment names and main technical parameters are summarized.It solves the practical problem that the abstract standard terms are combined with the concrete testing and the instruments and equipment used.It provides a new angle to study GB9706.1 standard.

关 键 词：医用电气设备 安全通用要求 仪器设备 

分 类 号：TH772[机械工程—仪器科学与技术]