Tests for Genotoxicity (ISO 10993-3)

Tests for Genotoxicity (ISO 10993-3)

With the genotoxicity test, it is tried to determine whether gene mutations, changes in chromosome structures, other DNA or genetic changes occur by using cells of mammalian or non-mammalian living things, bacteria or fungi.

Genotoxicity assessments use a range of in vitro and in vivo tests to detect mutagens and substances that directly or indirectly cause genetic damage through a variety of mechanisms. This damage can occur in somatic or germline cells, increasing the risk of cancer or inherited defects. A series of in vitro tests are applied in the evaluation of genotoxicity of medical devices.

ISO 10993-1 specifies the assessment of genotoxic potential for devices that are implanted and have prolonged contact (> 24 hours) with internal tissues and blood. May require genotoxicity assessment in extracorporeal devices with limited contact (<24 hours). At least three tests are required for the evaluation of genotoxicity. At least two of these are performed on mammalian cells. If in vitro test results indicate potential genotoxicity, in vivo genotoxicity testing should be performed.

Invitro Genotoxicity tests;

• Bacterial Back Mutation Test (AMES) - OECD TG 471
• In vitro mammalian Chromosome Aberration Test- OECD TG 473
• In vitro mammalian cell Gene Mutation Test-OECD TG 476
• In vitro mammalian cell Micronucleus Test-OECD TG 487