Standard

NS-EN ISO 18113-3:2024

Publisert
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.This document can also be applicable to accessories.This document does not apply to:a) instructions for instrument servicing or repair;b) IVD reagents, including calibrators and control materials for use in control of the reagent;c) IVD instruments for self-testing.

Dokumentinformasjon

  • Standard fra SN , 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, 2017/746

Produktrelasjon

Produkt livssyklus