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ISO TS 24971-2:2026

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence

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Valid from 17.06.2026
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None

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Status
Date
Type
Name
17.06.2026
Main

ISO TS 24971-2:2026 This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.

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