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Standard

SN EN ISO 10993-1:2010

Withdrawn

Note: Latest version: SN EN ISO 10993-1:2021

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Abstract

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.

Products specifications

  • Standard from INB
  • Published:
  • Withdrawn:
  • Effective:
  • Document type: EN
  • Pages
  • ICS: 11.100.20
  • Publisher: SNV
  • Distributor: SNV
  • National Committee: INB/NK 129

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