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CEN ISO/TS 24971-2:2026

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026)

General information

Valid from 15.07.2026
Base Documents
ISO/TS 24971-2:2026; CEN ISO/TS 24971-2:2026
Directives or regulations
None

Standard history

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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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