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

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.