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Standard

NS-EN ISO 10993-1:2003

Tilbaketrukket

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

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Tjenester

Omfang

This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2)

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2
  • 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
90/385/EEC
93/42/EEC

Produktrelasjon

Produkt livssyklus