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Standard

NS-EN ISO 10993-6:2007

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 10993-6:2016

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2007-04
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.100.20
  • National Committee SN/K 115

Referanser i lov

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

Produktrelasjon

Produkt livssyklus