Sia Analiz
Cytotoxicity Tests
The first of the biocompatibility tests to be carried out within the scope of biological risk assessment of medical devices is the cytotoxicity tests in the ISO 10993-5: 2010 standard. The in vitro cytotoxicity test allows the suppression of proliferation of cells interacting with medical devices under laboratory conditions or the lethal (cytotoxic) effects on cells to be determined qualitatively and quantitatively. For this purpose, it is used directly with the medical device and the cytotoxic effect that may occur as a result of the interaction with the substances that may leak from the medical device, or more often the extracts (extracts) obtained from the medical device by using solvents that have the potential to meet polar, apolar or both, the cytotoxic effect is evaluated by interacting with the cells.
MTT, Agar Diffusion, and Filter Diffusion tests, which are accepted within the scope of ISO 10993-5 standard, are performed by expert personnel in the cell culture laboratory of the SIA Analysis Laboratory. Which of these tests to do can be recommended by the customer and our laboratory.
The MTT test is applied to certified L929 fibroblast cells standardized at different concentrations of the medical device extract obtained from a polar, nonpolar, or semi-polar solvent, and the resulting toxicity is measured by colorimetric methods.
In the agar diffusion test, an agar layer is formed on L929 fibroblast cells grown in cell culture dishes. The substances that leak from the medical device placed directly on the agar or from the test unit impregnated with the extract from the medical device pass through the agar layer and reach the cells and interact with the cells and may show some lethal effects. These effects are evaluated semi-quantitatively.
In the filter diffusion test, cells grown on filters with certain pore diameters are inverted and covered on agar. Substances leaking from the medical device applied directly on the filter or from the material the extract is impregnated with pass through the filter and reach the cells. A semi-quantitative evaluation is made by measuring the zone diameters of the cell-free regions formed.
Depending on the nature of the product, one or more of these tests, if deemed necessary, is performed and the cytotoxicity assessment of the medical device is made. In Sia Analysis laboratories, cytotoxicity studies on L929 fibroblasts and different cell lines upon request are made by our experts, by deciding on a product basis. Cytotoxicity studies within the scope of medical devices are a test that should be performed on all products that require biocompatibility testing. It is at the beginning of the tests to be done in the evaluation of biocompatibility. As it is a reference to shed light on other biocompatibility tests, the reliability of the test and the results are very important. For this reason, our laboratory, which carries the GLP declaration of conformity, which is an important quality certificate, offers this confidence to our customers.
