Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


AAMI CR34971:2022

AAMI Consensus Report - Guidance on the application of ISO 14971 to artificial intelligence and machine learning

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.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

Classification of defects in health software
Standard for Safety for Medical Device Interoperability
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the ...
Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.