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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO 10993-5:2009 |
| Product Name | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |