We offer tests for biological evaluation of medical devices following methods designed to determine the biological response of mammalian cells in vitro. The biological evaluation of medical devices requires the application of ISO 10993: “Biological evaluation of medical devices”. Our laboratory is specialized in test methods to assess the in vitro cytotoxicity of medical devices (ISO 10993-part 5: Test for in vitro cytotoxicity) in the three categories of test: extract, direct contact, indirect contact. The cytotoxicity can be determined by assessments of cell damage by morphological means, measurements of cell damage, measurements of cell growth and measurements of specific aspects of cellular metabolism.
Our lab also offers special tests:
- Hemocompatibility test.
- Assessment of apoptosis.
- Activation of immune response.