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prSRPS CEN ISO/TS 24971-2:2026

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026)

General information

10.99     May 2, 2024

ISS

Z076

Technical Specification

11.040.01  

English  

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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prSRPS CEN ISO/TS 24971-2:2026
10.99 New project approved
May 2, 2024

Related project

Adopted from CEN ISO/TS 24971-2:2026 IDENTICAL

Adopted from ISO/TS 24971-2:2026 IDENTICAL