人工智能医疗器械标准体系设计探索  

Design of Standard System for Artificial Intelligence Medical Device

作　　者：王浩[1] 唐桥虹 郝烨[1] 孟祥峰[1] 李佳戈[1] 李静莉[1] WANG Hao;TANG Qiaohong;HAO Ye;MENG Xiangfeng;LI Jiage;LI Jingli(Institute for Medical Device Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京102629

出　　处：《中国医疗设备》2021年第12期15-18,28,共5页China Medical Devices

基　　金：国家重点研发计划(2019YFC0118802)。

摘　　要：目的研究AI医疗器械质量评价需求和标准体系设计。方法围绕国内外AI医疗器械监管政策与标准化动态,开展文献调研;结合产品测试经验,分析AI医疗器械标准发展的方向和定位。结果AI医疗器械的标准体系需要面向产品全生命周期监管与质量管理的需要,协调推进基础标准、方法标准的制修订,在时机成熟时进一步发展产品标准、管理标准。结论本文研究的策略有助于推动AI医疗器械标准化工作,完善质量评价体系。Objective To analyze the need for quality evaluation of artificial intelligence AI medical device and design the standard system.Methods This artical conducted literature study on the update of regulation policy and standardization of AI medical device in China and other countries;analyzed the orientation and direction of AI medical device standards,in combination with experience from AI medical device product testing.Results The standard system of artificial intelligence medical devices should be oriented to the needs of product life-cycle supervision and quality management,coordinate and promote the formulation and revision of basic standards and method standards,and further develop product standards and management standards when the time is ripe.Conclusion The strategy in this paper may promote the development of AI medical device standards and improve the technology system to evaluate AI medical device products.

关 键 词：人工智能医疗器械 质量评价体系 质量管理 

分 类 号：R197.39[医药卫生—卫生事业管理] TH773[医药卫生—公共卫生与预防医学]