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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
17. 6. 2026.

Опште информације

60.60     17. 6. 2026.

ISO

ISO/TC 210

Tehnička specifikacija

35.240.80     35.240.01     11.040.01  

engleski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO/TS 24971-2:2026
60.60 Standard objavljen
17. 6. 2026.