Standard

NS-EN ISO 18113-5:2009

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 18113-5:2024

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 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:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.100.10
  • National Committee SN/K 116

Referanser i lov

EU lov: 98/79/EC

Produktrelasjon

Produkt livssyklus