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

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.