ISO 10993-5:2009 Preview
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
This standard was last reviewed and confirmed* in 2017.
*Therefore this version remains current
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.