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ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971
Part 2: Machine learning in artificial intelligence
Part 2: Machine learning in artificial intelligence
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Summary
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.
Notes
30.99 : CD approuvé pour enregistrement comme DIS
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 06/17/2026 |
| Edition | 1 |
| Page Count | 32 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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