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Released: 2026-08-01
UNE CEN ISO/TS 24971-2:2026
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026) (Endorsed by Asociación Española de Normalización in August of 2026.)
Dispositivos médicos/Productos sanitarios (MD). Orientación para la aplicación de la Norma ISO 14971. Parte 2: Aprendizaje automático en inteligencia artificial (ISO/TS 24971-2:2026) (Ratificada por la Asociación Española de Normalización en agosto de 2026.)
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| Standard number: | UNE CEN ISO/TS 24971-2:2026 |
| Released: | 2026-08-01 |
| Status: | Standard |
| Pages (English): | 35 |
DESCRIPTION
UNE CEN ISO/TS 24971-2:2026
This document provides guidance on risks specific to 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.
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