In-vitro cytotoxicity test according to 10993-5
The in-vitro test for cytotoxicity is the most common biosafety test according to ISO 10993.
Our laboratory has an ISO 17025 accreditation and GLP certification for this test and has many years of experience with this cell culture-based test system, which is often used not only for end product testing, but also for monitoring cleaning processes, for example, or for the selection and inspection of incoming materials and raw materials or intermediate products.
In this test, an extract of the product to be tested is created. For this purpose, we have developed suitable extraction options for a wide variety of medical products.
The extract is brought into contact with the test cells. The viability of the cells is then determined by visual detection of a vital dye. A reduction in viability of more than 30% indicates a cytotoxic reaction.