Standard

NS-EN ISO 10993-11:1995

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 10993-11:2018

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.01
  • ICS 11.100
  • ICS 11.100.01
  • ICS 11.120
  • ICS 11.120.01
  • National Committee SN/K 115

Referanser i lov

EU lov: 90/385/EEC, 93/42/EEC

Produktrelasjon

Produkt livssyklus