体外诊断医用设备中运动零部件的安全要求  

Safety Requirements for Moving Parts of in Vitro Diagnostic Medical Equipment

作　　者：韩晓鹏 黄艳春 冯磊 梁振士 Han Xiaopeng;Huang Yanchun;Feng Lei;Liang Zhenshi(Beijing Institute of Medical Device Testing,Beijing 101111,China)

机构地区：[1]北京市医疗器械检验研究院,北京101111

出　　处：《医疗装备》2023年第4期40-42,47,共4页Medical Equipment

摘　　要：该研究对体外诊断医用设备适用的《测量、控制和实验室用电气设备的安全要求第1部分:通用要求》、《测量、控制和实验室用电气设备的安全要求第9部分:实验室用分析和其他目的自动和半自动设备的特殊要求》及IEC标准中关于运动零部件的安全要求进行了介绍,并给出了运动零部件符合性判定的流程图,以期帮助从业人员更好地理解标准要求,设计出符合要求的产品。In this paper, the safety requirements for moving parts in Safety requirements for electrical equipment for measurement, control, andlaboratory use-Part 1:General requirements, Safety requirements for electrical equipment for measurement, control and laboratory use—Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes and IEC standards applicable to in vitro diagnostic medical equipment were interpreted, and the flow chart for determining the compliance of moving parts was provided, in order to help practitioners better understand the standard requirements and design products that meet the requirements.

关 键 词：体外诊断 运动零部件 安全 

分 类 号：TH776[机械工程—仪器科学与技术]