DIN EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10

Standard No.
DIN EN ISO 10993-5:2009
Release Date
2009
Published By
German Institute for Standardization
Status
Replace By
DIN EN ISO 10993-5:2009-10
Latest
DIN EN ISO 10993-5:2009-10
Replace
DIN EN ISO 10993-5:2007
Scope
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

DIN EN ISO 10993-5:2009 Referenced Document

  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*2018-08-01 Update

DIN EN ISO 10993-5:2009 history

  • 2009 DIN EN ISO 10993-5:2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
  • 2009 DIN EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10
  • 0000 DIN EN ISO 10993-5:2007
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10



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