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
BHD
74.38
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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