Standard

NS-EN ISO 18374:2025

Publisert

Rettelser og tillegg kjøpes separat.

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Omfang

This document applies to software for 2D x ray image analysis in dental medicine, the basis of which is the application of artificial intelligence (AI).The scope of applicability of this document includesa) Software-as-a-Medical Device (SaMD)b) Software-in-a-Medical Device (SiMD) andc) Software to improve the efficiency of healthcare applications.This document applies to AI applications that learn statically and continuously/incrementally.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2025-05
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.060.01
  • ICS 35.240.80

Produktrelasjon

  • Adoptert fra: EN ISO 18374:2025