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

  • 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。

     

    Abstract: Datasets, as an important resource for artificial intelligence medical device industry, have been placed under medical device supervision. National Medical Products Administration (NMPA) has published a sectoral standard named YY/T 1833.2-2022 Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirement for Datasets to guide dataset quality evaluation. This standard describes 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 construction and better meet industry need. This article introduces the background and key points of the standard, in order to better guide the applications in artificial intelligence medical device industry.

     

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