摘要
国家食品药品监管局组织全国医用电器标准技术委员会起草发布了YY0505-2012《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》医疗器械行业标准。该标准于2014年1月1日起正式实施。医疗器械生产企业在电磁兼容标准发布实施后应立即在研制、生产等全过程中贯彻实施电磁兼容标准，确保产品符合电磁兼容标准要求。
The State Food and drug administration organization of national medical appliance standards technical committee drafted YY0505-2012 “medical electrical equipment part first ~ 2： General requirements for safety and electromagnetic compatibility requirements and test standards of medical devices industry standard”. This standard wil be formal y implemented from January 1, 2014. Medical device manufacturing enterprise in EMC standards issued immediately in the process of developing, production, implementation of EMC standards implementation, to ensure that products meet the standard of electromagnetic compatibility requirements.
出处
《中国医疗器械信息》
2014年第2期60-62,74,共4页
China Medical Device Information
