摘要
介绍当前不同国家中应用无线通信技术的医疗设备电磁兼容测试法规的要求,重点分析了美国、欧盟对无线医疗设备的电磁兼容要求,并对我国的检测要求和发展方向进行了说明。最后指出无线医疗设备产品获得认证时需要注意的问题。
According to the development of medical devices,the EMC testing regulations which apply to medical devices with wireless communication technology in different countries are proposed.The EMC requirements in the United States and in the European Union are mainly introduced.Test requirements and development direction for medical device certification in China are briefly discussed as well.At last,issues needing attention in the process of certification are proposed for medical device with wireless communication function.
关键词
无线通信
医疗设备
电磁兼容
指令
wireless communication
medical device
EMC
directive
