These are the analyses performed to evaluate the in vitro cytotoxicity (cellular toxicity) of medical devices. In other words, the biological response (cell growth, cell death, etc.) of the medical device to be tested in the tissue and body fluid it comes into contact with is simulated on mammalian cells and presented as a qualitative and quantitative report.
In vitro Cytotoxicity analyses are performed according to the following standards.
TS EN ISO 10993-5- Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
TS EN ISO 10993-12- Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
