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ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Standard Details

ISO 10993-5:2009 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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 10993-5:2009
Document Year: 2009
Pages: 34
Edition: 3
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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ISO 10993-5:2009
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