医疗器械电磁兼容试验中工作模式的确定  

Determination of Working Mode in EMC Test of Medical Devices

作　　者：李佳戈[1] 苏宗文[1] 任海萍[1] LI Jiage;SU Zongwen;REN Haiping(Division of Active Medical Device and Medical Optics,Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所光机电室

出　　处：《中国医疗设备》2019年第9期17-19,23,共4页China Medical Devices

基　　金：国家重点研发计划（2017YFC0111004）

摘　　要：为了明确医疗器械电磁兼容试验中工作模式的确定方法,本文从工作模式的基本要求谈起,结合实例与检测问题,讨论工作模式与被测设备(Equipment Under Test,EUT)及基本性能的关系。通过分析,本文认为医疗器械电磁兼容试验工作模式的确定,应从EUT的基本组成、供电模式、临床功能、辅助设备、可持续状态这5个方面要素进行确认。In order to clarify the method of determining the working mode in EMC test of medical devices,this paper discussed the relationship between the working mode and the equipment under test(EUT)and its basic performance,starting from the basic requirements of the working mode,combining with examples and detection problems.Through the analysis,this paper held that the determination of the working mode of EMC test for medical devices should be based on the basic composition of EUT,power supply mode,clinical function,auxiliary equipment and sustainable state.

关 键 词：医疗器械 医用电气设备 电磁兼容 试验运行状态 

分 类 号：O441[理学—电磁学] R197.39[理学—物理]