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About This Item


Full Description

This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.


Document History

  1. AAMI TIR34971:2023


    Application of ISO 14971 to machine learning in artificial intelligence—Guide

    • Most Recent
  2. AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

    • Historical Version