摘要
基于现阶段医疗器械法规的要求,结合远红外贴的基本原理及使用风险,对远红外贴的安全性、关键指标、临床评价、产品使用等基本要点进行研究。
Based on the requirements of the current medical device regulations,combined with the basic principles and risks of far-infrared stickers,we study the basic points of safety,key indicators,clinical evaluation and product use of far-infrared stickers.
作者
赖锦坝
许晓萍
张龚敏
LAI Jin-ba;XU Xiao-ping;ZHANG Gong-min(Center for Certification and Evaluation,Guangdong Drug Administration,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2019年第7期36-37,共2页
China Medical Device Information
关键词
远红外贴
安全有效
技术审评
far infrared sticker
safety and effectiveness
technical review
