中国医疗设备2017，Vol.32Issue(6)：16-19,4.DOI:10.3969/j.issn.1674-1633.2017.06.005
浅谈我国对医疗器械微功率无线电技术的监管要求
Study on the Regulation Requirement of Micropower Wireless Communication in Medical Device
摘要
Abstract
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.关键词
微功率/无线电/移动医疗器械/型号核准/技术监管Key words
micropower/wireless communication/mobile medical device/SRRC type approval/technical regulation分类
信息技术与安全科学引用本文复制引用
罗维娜,李澍,王浩,王晨希,任海萍..浅谈我国对医疗器械微功率无线电技术的监管要求[J].中国医疗设备,2017,32(6):16-19,4.基金项目
中国药品监督管理研究会课题"移动医疗发展趋势与监管政策研究". （）
