Standard

ISO/TS 24971-2:2026

Jun 2026 Draft

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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 ISO
Published: 17 June 2026
Edition: 1
Version: 1
Document type: TS
ISBN:

ICS 35.240.80
ICS 35.240.01
ICS 11.040.01
ISO TC ISO/TC 210

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Joinded work item: IEC/SC62A

ISO/TS 24971-2:2026

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Abstract

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