Standard

NEK CEN ISO/TS 24971-2:2026

Jul 2026 Published

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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.

Document information

Standard from NEK
Published: 29 July 2026
Edition: 2026-06
Version: 1
Document type: TS
ISBN:

ICS 11.040.01
National Committee CEN/CLC/JTC 3

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Joinded work item: SN-CEN ISO/TS 24971-2:2026
Adopted from: CEN ISO/TS 24971-2:2026

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Abstract

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