ISO TS 24971-2:2026
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2026 |
| No. of Pages | 32 |
| ICS Classification | 11.040.01 Medical equipment in general 35.240.01 Application of information technology in general 35.240.80 IT applications in health care technology |
| Committee | TC 62/SC 62A |
| Available for Purchase | For sale in Singapore only |
| Adoption | IEC : 0 |