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AAMI 10993-5
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AAMI 10993-5 2009 Edition, January 1, 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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Description / Abstract:
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.
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.