医用电气设备电磁兼容性风险管理文档规范性探讨  

Normalization of Risk Management Documents for Electromagnetic Compatibility of Medical Electrical Equipment

作　　者：马佳祺 任江涛 周平[1,2] MA Jiaqi;REN Jiangtao;ZHOU Ping(Chongqing Centre for Medical Devices Control,Chongqing,China 400799;Bioengineering College of Chongqing University,Chongqing,China 400044)

机构地区：[1]重庆医疗器械质量检验中心,重庆400799 [2]重庆大学生物工程学院,重庆400044

出　　处：《中国药业》2024年第19期9-13,共5页China Pharmaceuticals

基　　金：国家重点研发计划课题[2018YFC0117203]。

摘　　要：目的为制造商在医用电气(ME)设备产品的设计和生产过程中的电磁兼容性风险管理提供参考。方法对《医用电气设备第1部分:基本安全和基本性能的通用要求》(GB 9706.1—2020)中“17 ME设备和ME系统的电磁兼容性要求”,以及最新国际标准中医用电气设备或医用电气系统(以下简称ME设备/系统)的电磁兼容性风险管理实施相关要求进行梳理和综合分析,提出医用电气设备电磁兼容性风险管理文档的编写思路。结果与结论医用电气设备电磁兼容性风险管理可从ME设备/系统使用地点存在的电磁骚扰、发射的电磁骚扰的风险管理等方面入手。该研究可为ME设备/系统的电磁兼容性风险管理过程及其文档编制提供参考。Objective To provide a reference for manufacturers to carry out the risk management on electromagnetic compatibility(EMC)in the design and production process of medical electrical(ME)equipment products.Methods A comprehensive analysis was conducted on the"17 EMC of ME Equipment and ME Systems"in the Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential Performance(GB 9706.1-2020),as well as the relevant requirements for EMC risk management of ME equipment or ME systems in the latest international standards.The writing thoughts of EMC risk management documents for ME equipment were put forward.Results and Conclusion The risk management of EMC in ME equipment can be approached from the aspects of electromagnetic disturbance existing at the location of the use of ME equipment/systems and electromagnetic disturbance emitted.This study can provide a reference for the electromagnetic compatibility risk management process and documentation of ME equipment/systems.

关 键 词：医用电气设备 医用电气系统 电磁兼容性 风险管理 

分 类 号：R95[医药卫生—药学]