International standard
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Published Jun 17, 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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.