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YY0505-2012是医用电气设备电磁兼容测试的主要标准,与其它行业相比,医用电气设备的电磁兼容检测起步较晚,该行业标准又直接与国际电工委员会发布的IEC 60601-1-2接轨,所以在2014年医用电器设备的注册检验时,面对强制要求实施与执行电磁兼容标准时总是一头雾水。借着“一带一路”政策和四大类医疗器械产品进入“十三五”规划的东风,国产医用电气市场向海外延伸的趋势正在加速。本文以帮助企业的研发和质控人员为目的,对国内外主要标准的关键差异进行了筛选对比,以期国产医疗器械在国际认证中少走弯路。
YY0505-2012 is the main standard for electromagnetic compatibility test of medical electrical equipment. Compared with other industries, the electromagnetic compatibility testing of medical electrical equipment started later, and the industry standard is directly connected with IEC60601-1-2 released by the International Electrotechnical Commission. Therefore, in 2014 the registration of medical electrical equipment inspection, the face of mandatory requirements for implementation and implementation of electromagnetic compatibility is always confused. With the “Belt and Road” policy and the entry of the four major categories of medical device products into the “13th Five-Year Plan”, the trend of overseas expansion of the domestic medical electrical market is accelerating. In order to help R & D and quality control personnel in enterprises, this paper screened and compared the key differences between the major standards both at home and abroad with a view to making domestic medical devices less detours in international certification.