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Standard

SN EN ISO 10993-1:2010

Ritirato

Nota: Ultima versione: SN EN ISO 10993-1:2021

Anteprima

Le modifiche e le versioni esistenti o nuove devono essere acquistate separatamente.

Lingua
Servizi

Astratto

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.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Ritirato:
  • Efficace:
  • Tipo di documento: EN
  • Pagine
  • ICS 11.100.20
  • Publisher SNV
  • Distributor SNV
  • National Committee INB/NK 129

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