Tests for in vitro cytotoxicity (ISO 10993-5)

In vitro Cytotoxicity Tests are based on testing the biological responses on mammals that will occur depending on the contact time of the medical device to be tested with the tissue and body fluid it will come into contact with.

The prepared sample extracts are applied to cultured cells to identify product-induced toxicity such as cell death and cell growth. Cytotoxicity tests are carried out qualitatively and quantitatively. Qualitative tests are grouped under 3 main headings.

Direct Contact,
MEM Elution
Agar Diffusion Tests

Colorimetric methods used for quantitative viability/survival tests are based on the binding of dye to living cells.

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