GB30428107
Application of ISO 14971 to machine learning in artificial intelligence. Guide
Last updated: 7 Jan 2025
Development Stage
Pre-draft
Draft
Published
31 May 2023
Scope
What is BS AAMI 34971 – Application of ISO 14971 to machine learning in artificial intelligence – Guide about?
Artificial intelligence can bring many benefits to healthcare but can also present unique risks. To treat those appropriately, BSI and the US Association for the Advancement of Medical Instrumentation (AAMI) have jointly developed BS AAMI 34971:2023. This new document complements BS EN ISO 14971 on assessing and managing the risks associated with medical devices by giving additional guidance on applying ISO 14971 when evaluating medical technology using AI and particularly machine learning.
External Links
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Categorisation
Domain: Healthcare and medicine
Scope: AI-specific
Key Information
Organisation: BSI
Relevant UK committee: CH/210/4
Discussion
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