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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)

Publication date:   Aug 13, 2026

General information

60.60   Standard published   Jun 24, 2026

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Technical Specification

11.040.01   Medical equipment in general

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Scope

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.

Life cycle

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PUBLISHED
CEN ISO/TS 24971-2:2026
60.60 Standard published
Jun 24, 2026