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.
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.
LUO Wei-na, LI Shu, WANG Hao,
WANG Chen-xi, REN Hai-ping. Study on the Regulation Requirement of Micropower Wireless Communication
in Medical Device. China Medical Devices, 2017, 32(6): 16-19.