行业标准《人工智能医疗器械 质量要求和评价 第2部分:数据集通用要求》解析  

Interpretation on the Standard Artificial Intelligence Medical Device⁃Quality Requirements and Evaluation⁃Part 2:General Requirements for Datasets

作　　者：王浩[1] 孟祥峰[1] 郝烨[1] 李佳戈[1] 李静莉[1] WANG Hao;MENG Xiangfeng;HAO Ye;LI Jiage;LI Jingli(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《协和医学杂志》2023年第6期1180-1184,共5页Medical Journal of Peking Union Medical College Hospital

基　　金：中国食品药品检定研究院关键技术基金(GJJS-2022-3-1)。

摘　　要：数据集作为人工智能医疗器械行业的重要基础资源,已纳入医疗器械的监管视野。国家药品监督管理局于2022年发布了行业标准YY/T 1833《人工智能医疗器械质量要求和评价》系列标准,其中第2部分为数据集通用标准,该标准描述了数据集对文档、质量特性的要求,提出了数据集质量评价方法,指导数据集制造责任方从源头加强数据集质量控制,为数据集质量评价提供了统一规范,有利于帮助临床机构加强数据集建设,更好地对接产业发展需求。本文对该部分标准的制订背景及要点内容进行解析,以期更好地指导行业应用。Datasets,as an important resource for artificial intelligence medical device industry,have been placed under medical device supervision.National Medical Products Administration(NMPA)has pub-lished a sectoral standard named YY/T 18332-2022 Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2:General Requirement for Datasets to guide dataset quality evaluation.This standard de-scribes dataset requirements for documentation and quality measures,proposes evaluation methods,and helps dataset producers enhance quality control from the source.It would benefit clinical agencies in dataset construc-tion and better meet industry need.This article introduces the background and key points of the standard,in or-der to better guide the applications in artificial intelligence medical device industry.

关 键 词：YY/T 1833.2-2022 人工智能 医疗器械 数据质量 数据集 

分 类 号：R-05[医药卫生] R608[自动化与计算机技术—计算机科学与技术] TP3