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Standard

NS-EN ISO 10993-1:2009

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 10993-1:2020

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2009-10
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.01
  • ICS 11.100
  • ICS 11.100.20
  • ICS 11.120.10
  • National Committee SN/K 115

Referanser i lov

EU lov:
Lov referanseRestriksjoner
2007/47/EC
90/385/EEC
93/42/EEC

Produktrelasjon

Produkt livssyklus