Genotoxicity
Genotoxicity
Testing for genotoxicity for biocompatibility have many methods and standards. These tests include Ames Mutagenicity, Chromosomal Aberration, Mouse Lymphoma, and Mouse Micronucleus. All tests adhere to OECD and ISO standards, including ISO/AAMI/ANSI 10993-3, ASTM E1687, OECD 471, OECD 473, and ANSI/AAMI/ISO 10993-12.
The Ames Test for Mutagenicity assesses if a medical device or material extract can cause mutations. The Chromosomal Aberration Test determines if a medical device or material can cause structural chromosomal abnormalities in Chinese Hamster Ovary cells. The Mouse Lymphoma Test is used to examine if a medical device, material, or its extract can induce genotoxicity. Lastly, the Mouse Micronucleus Assay is used to assess if a medical device can trigger the development of micronuclei in immature polychromatic erythrocytes in adult mice’s bone marrow.
These tests are necessary to ensure that medical devices that come in contact with the body for an extended period of time do not induce genotoxicity and increase the risk of cancer. By performing these tests, Nelson Labs is able to provide reliable data for medical professionals and patients.
