ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2026 |
| No. of Pages | 32 |
| ICS Classification | 35.240.80 IT applications in health care technology 35.240.01 Application of information technology in general 11.040.01 Medical equipment in general |
| Committee | ISO/TC 210 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO : 0 |