Standard

NS-EN ISO 18113-5:2024

Publisert
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
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Omfang

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.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 professional use.

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