The Mouse Lymphoma uses cell cultures, usually mammalian, to determine gene mutations, change in chromosome structure and number, and other gene toxicities caused by medical devices, material, or their extracts. These tests are used to ensure devices that have prolonged contact with the body do not elicit genotoxicity that in turn might cause gene mutations with a potential for cancer. Biocompatibility Genotoxicity tests comply with ISO 10993-1 and ISO 10993-3 standards.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
- ISO 10993-3