AAMI CR34971:2022 [HISTORICAL]

This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for artificial intelligence (AI) or machine learning (ML) incorporating medical devices.  This AAMI Consensus Report does not provide a new risk management process, nor does it expand the requirements of ISO 14971. Rather, it provides guidance to assist those who are applying ISO 14971 to regulated AI medical technologies.   There are many different algorithms that can support AI, including technologies such as decision trees, genetic algorithms, and neural nets. Often, when people are discussing AI, they are specifically talking about Machine Learning systems. Since Machine Learning (ML) systems are often more complicated and more opaque than other approaches, this report focuses on ML-related risks. This document has been superseded by  AAMI TIR34971:2023; Application of ISO 14971 to machine learning in artificial intelligence—Guide. This document is no longer being maintained by AAMI and should not be used for new designs.  Every AAMI standard is subjected to review at least every five (5) years. When a standard is more than five years old, has not undergone revision or review, and/or no longer carries the ANSI designation, it is reasonable to conclude that the contents, while still of some historic value, do not reflect the present state of the art. All copyrights remain in full effect. No annex