Standard

NS-EN ISO 18113-2:2024

Publisert

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) reagents, calibrators and controls intended for professional use.This document can also be applicable to accessories.This document is applicable to the labels for outer and immediate containers and to the instructions for use.This document does not apply to:a) IVD instruments or equipment;b) IVD reagents for self-testing.

Dokumentinformasjon

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

Referanser i lov

EU lov:
Lov referanseRestriksjoner
2017/746

Produktrelasjon

Produkt livssyklus