Genotoxicity Tests for Medical Devices

Within the scope of the standard “ISO 10993-3:2014 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity”, evaluation processes are carried out for medical devices for potential genotoxicity, carcinogenicity or reproductive toxicity.

The purpose of genotoxicity tests is to detect substances that cause genetic damage, such as gene mutations (point mutations) and chromosomal damage (ie translocations, minor or major deletions and insertions, and numerical chromosomal aberrations) by various mechanisms.

Genotoxicity tests are performed with a few steps since not all genotoxic effect types can be detected with a single test method.

1. Ames test, OECD 471 - a test for gene mutations in bacteria
2. OECD 473 - an in vitro test for chromosomal damage chromosome aberration test
3. OECD 476 - an in vitro mouse lymphoma tk test
4. OECD 478 - an in vitro mammalian cell micronucleus test for chromosomal damage and aneugenicity

For Genotoxicity Tests for Medical Devices, please contact Nanolab Medical Analysis Laboratory.