随着移动互联网技术的发展,无线通信越来越多地应用在有源医疗器械中,特别是移动医疗器械上.如何选取微功率无线电设备,如何满足医疗器械监管的要求,是工业界和学术界共同关心的问题.本文介绍了我国微功率无线电设备的管理现状和无线微功率无线电的技术核准要求,阐述了移动医疗器械针对无线电技术的监管要求,对于相关医疗器械的研发和注册给出了建议.%With the development of mobile internet, more and more wireless communication techniques have been applied in active medical device, especially in mobile medical device. How to select micropower wireless communication component and how to meet with medical device regulation are questions of common interest in the field of industry and academia. This paper introduced the management status of the micro power radio equipment and the technology for approval requirements of micropower wireless radio in our country. The regulatory requirement of wireless communication technique in mobile medical device was explained. Advice on the design and registration of related medical device was provided.
展开▼
