Standard

NS-EN ISO 18113-1:2024

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Rettelser og tillegg kjøpes separat.

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Omfang

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.This document does not address language requirements since that is the domain of national laws and regulations.This document does not apply to:a) IVD medical devices for performance evaluation (e.g. for investigational use only);b) shipping documents;c) material safety data sheets / Safety Data Sheets;d) marketing information (consistent with applicable legal requirements)..

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2024-06
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.100.10
  • National Committee SN/K 116

Referanser i lov

EU lov: 2017/746

Produktrelasjon

Produkt livssyklus