ISO/TS 24971-2:2026
ISO/TS 24971-2:2026 Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
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This publication was last reviewed and confirmed in 2026.
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Description
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.
Edition
1
Published Date
2026-06-19
Status
PUBLISHED
Pages
32
Language
English
Format
Secure PDF
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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.
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