Standard

ISO/TS 24971-2:2026

Utkast

Rettelser og tillegg kjøpes separat.

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Omfang

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.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 1
  • Versjon: 1
  • Varetype: TS
  • ICS 35.240.80
  • ICS 35.240.01
  • ICS 11.040.01
  • ISO TC ISO/TC 210

Produktrelasjon

  • Felles standardiseringsprosjekt: IEC/SC62A