One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33.
We conduct genotoxicity with both prokaryotic (bacterial strains – AMES method) and eukaryotic test systems (mammalian cell lines – Mouse Lymphoma Assay).
Genotoxicity testing applies to various kinds of medical devices, ranging from surface medical devices (e.g. coming into contact with mucosal membrane) to implants (and many other on the way). With these tests, we can evaluate if your product is prone to causing DNA damage in your patients’ cells.
These tests are considered the most time and work-consuming among the in vitro tests, yet our experienced team can handle your product with care and precision – you can be sure, that your results will be dependable and reliable.
You are not sure whether your products needs genotoxicity testing
Contact us to obtain more specific information, as well as consulting services. If your product is considered “unusual” – let us know, we can tailor the tests specifically for your needs. And guess what – GLP standard is also available.