ISO TS 24971-2:2026 ED1

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

Publication date: Jun 17, 2026

General information

Current stage: 60.60 Effective date: Jun 22, 2026

Originator: IEC

Owner: TC 62/SC 62A

Type: Technical Specification

ICS: 11.040.01 35.240.01 35.240.80

Languages: English

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Status: Published

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Scope

ISO TS 24971-2:2026 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.

Life cycle

NOW

PUBLISHED
ISO TS 24971-2:2026 ED1
60.60 Standard published
Jun 22, 2026