摘要
主动健康理念的深入人心推动了主动健康数据采集医疗器械的需求的提升,该类医疗器械电源部分大多采用锂电池供电或将锂电池作为备用电源供电,对其采用的锂电池技术,包括分类、应用、潜在安全风险、设计考量和相关标准进行介绍,并对该类医疗器械上市前提交的锂电池相关注册申报资料的技术审评要求予以探讨,为产业研发、监管研究及制造商注册申请提供参考。
The idea of active health is deeply rooted in people's mind,which has promoted the elevation of the demand of medical devices of data collection for active health.Mostly,Lithium battery is used as supplying power or as a standby power supply for this kind of medical devices.This article introduces the Lithium battery technique used in medical devices,including classification and application,potential safety risks and design factors,and related standards.And this article focuses on the requirement of evaluation of the relevant registration and declaration data of Lithium battery technique before this kind of device could be sold,and provides reference for research and development of industry,research of supervision,register and application.
作者
郑晨
张嵩
陈宽
许伟
ZHENG Chen;ZHANG Song;CHEN kuan(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China)
出处
《中国医学装备》
2020年第6期193-196,共4页
China Medical Equipment
基金
国家重点研发计划项目资助课题(2018YFC2000800)“主动健康产品和人体健康态评估的安全有效体系及标准体系研究”。
