ISO/TS 24971-2:2026

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

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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

PUBLISH DATE 2026
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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