ISO/TS 24971-2:2026

International Standard   Current Edition · Approved on 17 June 2026

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

ISO/TS 24971-2:2026 Files

English 32 Pages
Current Edition
OMR 75.67

ISO/TS 24971-2:2026 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.

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