Standard

NS-EN ISO 14155-2:2003

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 14155-2:2009

Rettelser og tillegg kjøpes separat.

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Omfang

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.This Standard does not apply to in vitro diagnostic medical devices.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.01
  • ICS 11.040.20
  • National Committee SN/K 113

Referanser i lov

EU lov:
Lov referanseRestriksjoner
90/385/EEC
93/42/EEC

Produktrelasjon

Produkt livssyklus