ISO 10993 5:2009

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

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

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

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.

Edition2009
Standard Part No5
Published Date2009
Published ByInternational Standardization Organisation
Page Count34