Standard

NS-EN ISO 10993-18:2005

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 10993-18:2020

Rettelser og tillegg kjøpes separat.

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Omfang

This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2005-07
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.100
  • 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