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Standard

ISO 10993-1:2009

Tilbaketrukket

Obs: Denne standarden har et forslag: ISO/FDIS 10993-1

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 ISO
  • Publisert:
  • Tilbaketrukket:
  • products.specs.Expires:
  • Utgave: 4
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

Produktrelasjon

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