医用电气设备电磁兼容随机文件的常见问题解析  

Analysis of Common Problems in EMC Accompanying Doucuments of Medical Electrical Devices

作　　者：高中 王乾方[2] 张芷菁 Gao Zhong;Wang Qianfang;Zhang Zhijing(Shanghai Testing and Inspection Institute for Medical Devices,Shanghai 201318,China;The First Affiliated Hospital of Chengdu Medical College,Chengdu Sichuan 610500,China)

机构地区：[1]上海市医疗器械检测所,上海201318 [2]成都医学院第一附属医院,四川成都610500

出　　处：《医疗装备》2020年第13期35-37,共3页Medical Equipment

摘　　要：针对制造商对随机文件中的标识、警示和说明书的理解存在的误区,该研究对射频发射模块标识及警示、静电放电豁免条件、样品预期用途及使用场景的确定等外部标识常见问题、使用说明书常见问题及技术说明书常见问题进行了阐述,同时结合标准中的规定,进一步明确了问题的本质,并给出了合理的建议,特别是对技术说明书中表格的应用问题给出快速应用表格,以帮助制造商进一步提升对检测和标准的认知。In view of the misunderstanding of the manufacturer's identification,warning and instructions in the random documents,the common problems of external identification such as the identification and warning of RF transmitter module,the exemption conditions of ESD sensitivity,the determination of the intended use of the sample and the use scenario,the common problems of the operation ins truction and the common problems of the technical instruction are described in this paper.At the same time,it combines the provisions of the standard,further clarify the nature of the problem,and give reasonable suggestions,especially for the application of the form in the technical specifications,to help manufacturers further improve the awareness of the tests and standards.

关 键 词：医用电气设备 电磁兼容 随机文件 

分 类 号：TH772[机械工程—仪器科学与技术]