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.