Standard

NEK CEN ISO/TS 24971-2:2026

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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 NEK
  • Publisert:
  • Utgave: 2026-06
  • Versjon: 1
  • Varetype: TS
  • ICS 11.040.01
  • Nasjonal komité CEN/CLC/JTC 3

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