医疗器械行业标准YY0505-2012及电磁发射测试解读

Medical Device Industry Standard YY0505-2012 and Interpretation of Electromagnetic Emission Test

有源医疗器械在临床应用的各个领域都扮演着举足轻重的角色,现代临床医学离不开有源医疗器械.近年来我国非常重视国产医疗器械产品的自主研发,而对于医疗器械标准的实施也是紧跟欧美日等发达国家步伐,医用电气设备和系统YY 0505-2012《医用电气设备第1-2部分:安全通用要求并列标准:电磁兼容要求和试验》自2014年1月1日发布实施以来,对我国有源医疗器械行业产生巨大影响,之前已经发布实施的专用标准中有关电磁兼容的内容也随即开始执行.文章主要是对医疗器械行业标准Y Y0505-2012及有源医疗器械电磁兼容测试的一些关键点进行解读.

Powered medical devices play an important role in every field of clinical application.Modern clinical medicine cannot do without powered medical devices.In recent years,China attaches great importance to the independent research and development of domestic medical device products.The implementation of medical device standards are also in line with the pace of developed countries such as Europe,the United States and Japan.Medical electrical equipment and systems YY 0505-2012 Medical electrical equipment-Part 1-2:General requirements for safety-Collateral stanards:Electromagnetic compatibility-Requirements and tests has had a huge impact on the powered medical device industry in China since it was issued and implemented on January 1,2014.Electromagnetic compatibility in the special standards that have been issued and implemented before will be implemented immediately.This paper mainly interprets the medical device industry standard YY0505-2012 and some key points of EMC test of powered medical devices.