IEEE P2802/D2, April 2022 IEEE Approved Draft Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
Institute of Electrical and Electronics Engineers (IEEE)
Scope
This standard is aimed at establishing concepts and terminology for the performance and safety evaluation of artificial intelligence medical device, which covers basic technology, dataset, quality characteristics, quality evaluation and application scenario. The annex further provides basic equations for quality evaluation purpose.