Standard

NS-EN ISO 18374:2025

Published

Corrigenda and amendments are bought separately.

Language
Services

Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2025-05
  • Version: 1
  • Document type: NAT
  • ICS 11.060.01
  • ICS 35.240.80

Product Relations

  • Adopted from: EN ISO 18374:2025