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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

Publication date:   Jun 17, 2026

General information

60.60   Standard published   Jun 17, 2026

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

Technical Specification

35.240.80   IT applications in health care technology | 35.240.01   Application of information technology in general | 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
ISO/TS 24971-2:2026
60.60 Standard published
Jun 17, 2026