Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
|Publication Date:||1 June 2009|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
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.