Genotoxicity Testing for Medical Devices

Genotoxicity tests detect substances in medical devices that could cause genetic damage via gene mutations or chromosomal damage. To ensure patient health and safety, many types of medical devices must adhere to the International Organisation for Standardisation’s “Tests of Genotoxicity, Carcinogenicity, and Reproductive Toxicity” as outlined in ISO 10993-3. This can help manufacturers understand and mitigate potential adverse effects to achieve positive patient outcomes. TÜV SÜD performs genotoxicity tests as part of our wide variety of biocompatibility tests. 

Any medical device must undergo biocompatibility testing to protect humans from potential biological risks and complications stemming from using medical devices. This process establishes the device’s biological safety  

So far, biocompatibility testing of medical devices has largely been conducted in terms of cytotoxicity, irritation, and sensitisation. However, regulators and users express growing concern that medical devices can also contribute to changes in the DNA structure. This is known as exerting genotoxic effects. This is why we conduct genotoxicity testing on devices intended for permanent implantation or prolonged bodily exposure to identify the potential presence of toxins that could impact the genetic material of cells. 

The ISO 10993-3 standard requires a structured biological evaluation plan within a risk management process. 

TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory frameworks worldwide. We are a comprehensive solution for most major medical device markets, providing end-to-end assistance with predictability and diligence. 

Our experts and state-of-the-art facilities offer thorough biocompatibility testing for medical devices, including genotoxicity testing. 

By helping to address medical manufacturers’ needs in determining and understanding the chemical characterisation process and testing outcomes, TÜV SÜD acts as a vital partner in ensuring regulatory compliance for organisations of all sizes. 

We take a proactive approach to anticipate technological developments and facilitate change. To define the next standards in safety, security and sustainability, our experts sit in standard-setting committees and consortia. 

Our service includes: 

• Genotoxicity - ISO 10993-3– Genotoxicity tests are required to identify the presence of toxins that can impact the genetic material of cells. 
  • Bacterial Reverse Mutation Assay – This test is conducted with engineered strains of Salmonella typhimurium and Escherichia coli designed to detect all possible single base pair changes as well as frameshift mutations [OECD 471 (1997) “Guidelines for Testing of Chemicals – Bacterial Reverse Mutation Test”].
  • In Vitro Mammalian Genotoxicity Assay – A choice of one of the following is recommended:
    • Mouse Lymphoma Gene Mutation Assay [OECD 476 (1997): “Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Gene Mutation Test”], which is preferred since it detects the broadest set of genotoxic mechanisms associated with carcinogenic activity.
    • In Vitro Chromosomal Aberration (CA) Assay [OECD 473 (2014): “Guidelines for the Testing of Chemicals – In Vitro Mammalian Chromosome Aberration Test”] is one of the tests that gives information of DNA damage through structural changes that are called as aberration.
    • In Vitro Micronucleus Assay [OECD 487 (2014): “Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Micronucleus Test”]. This test determines if a compound is genotoxic by evaluating the presence of micronuclei. Micronuclei are the result of DNA damage. It may contain chromosome fragments due to DNA breakage, or whole chromosomes. This test is able to provide information on clastogenicity and anuegenecity.