Standard

NS-EN ISO 10993-1:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-1:2025

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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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-10
  • Version: 1
  • Document type: NAT
  • ICS 11.040.01
  • ICS 11.100
  • ICS 11.100.20
  • ICS 11.120.10
  • National Committee SN/K 115

Legal references

EU law: 2007/47/EC, 90/385/EEC, 93/42/EEC

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