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sklademVydáno: 2026-06-17
ISO/TS 24971-2:2026
ISO/TS 24971-2:2026 - Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
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| Označení normy: | ISO/TS 24971-2:2026 |
| Vydání: | 1 |
| Vydáno: | 2026-06-17 |
| Počet stran (Anglicky): | 32 |
Popis
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.