医用电气设备电磁兼容发射试验常见问题探讨  

Common problems in electromagnetic compatibility emission tests of medical electrical equipment

作　　者：高中 张芸 王伟 GAO Zhong;ZHANG Yun;WANG Wei(Shanghai Testing and Inspection Institute for Medical Devices,Shanghai 201318,China)

机构地区：[1]上海市医疗器械检测所,上海201318

出　　处：《医疗卫生装备》2020年第7期86-88,98,共4页Chinese Medical Equipment Journal

摘　　要：分析了医用电气设备进行电磁兼容发射试验时的分组和分类以及测试前运行模式的选择等共性问题,介绍了传导发射试验中模拟手对测试结果的影响、辐射发射试验的测试距离和要求、谐波失真测试及电压波动和闪烁测试的适用性等个性问题。提出了企业应从注重对电磁兼容等标准的学习和宣贯、加强法规事务人员的专业性、将电磁兼容要求纳入产品研发和生产的全流程等方面综合考虑,系统性把握医用电气设备电磁兼容发射试验的要求。Some common issues were analyzed including the grouping and classification of EMC emission test of the medical electrical equipment,the selection of operation mode before test and etc.The individualized problems were introduced such as the influence of simulated hand on test results,test distance and requirements of radiation emission test as well as the applicability of harmonic distortion test and voltage fluctuation and flicker test.It was suggested that enterprises pay attention to the studying and implementation of EMC standards,strengthen the professionalism of regulatory personnel,and incorporate EMC requirements into the whole process of product development and production,so as to systematically grasp the requirements of EMC emission test for the medical electrical equipment.

关 键 词：医用电气设备 电磁兼容发射试验 传导发射 辐射发射 

分 类 号：R318.6[医药卫生—生物医学工程] TH789[医药卫生—基础医学]