行业标准《人工智能医疗器械 质量要求和评价 第1部分: 术语》解析

Interpretation on the Standard Artificial Intelligence Medical Device- Quality Requirements and Evaluation-Part 1: Terminology

  • 摘要: 随着人工智能医疗器械产业的壮大,产学研用各方急需在产品质量评价相关术语、概念方面达成共识,以支撑标准规范的发展。为突破行业瓶颈,国家药品监督管理局于2022年发布了YY/T 1833《人工智能医疗器械 质量要求和评价》系列标准。其中第一部分建立了统一的术语标准,包含基础技术术语、数据集术语、质量特性术语、质量评价术语、应用场景术语5个章节,共158个术语。本文介绍该术语标准的概况、制订规程及其意义,以期更好地指导人工智能医疗器械行业发展。

     

    Abstract: With the rise of artificial intelligence medical device (AIMD) industry, it is urgent for stakeholders to establish consensus on the definition and concepts of AIMD quality evaluation, so as to further support the development of standards and guidelines. To break through industry bottleneck, the National Medical Products Administration (NMPA) published YY/T 1833.1-2022 Artificial Intelligence Medical Device- Quality Requirements and Evaluation- Part 1: Terminology in 2022, which provides unified terminology. This standard is divided into five chapters, including a total of 158 terms that cover basic technology, data set, quality characteristics, quality evaluation and application scenario. This article introduces the general overview, the drafting history and explains its significance, with the aim of guiding the development of artificial intelligence medical device industry.

     

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