Technical Specification
ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Reference number
ISO/TS 24971-2:2026
Edition 1
2026-06
© ISO 2026
Technical Specification
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Published (Edition 1, 2026)

ISO/TS 24971-2:2026

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Abstract

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.

General information

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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