It is analysis of medical devices to evaluate the toxicity of in vitro cytotoxicity (cellular toxicity). In other words, the medical device, which will be tested in the form of tissue and body fluid, is performed caliquiactively and quantitatively on mammalian cells “cell growth, cell death, etc.» and presenting them as reported.
In vitro Cytotoxicity analyses are carried out according to the following standards.
TS EN ISO 10993-5- Biological evaluation of medical devices – Part 5: Out-of-body (in vitro) cytotoxicity experiments
TS EN ISO 10993-12- Biological evaluation of medical devices – part 12: Sample preparation and reference materials