Genotoxicity evaluation

Genotoxicity Assessment and Evaluation of Medical Devices

Learn the specifics of the genotoxicity assessment and evaluation in line with ISO 10993

Learn the specifics of the genotoxicity assessment and evaluation in line with ISO 10993

Conducting genotoxicity assessment and evaluation for medical devices can help manufacturers understand and mitigate potential adverse effects when the device heads to market.

Although biocompatibility testing of medical devices has largely been conducted in terms of sensitization, irritation, and system toxicity, there are growing concerns that medical devices can also contribute to changes in the DNA structure, exerting genotoxic effects. Now, in vitro genotoxicity assays must be conducted on devices that are intended for permanent implantation or prolonged bodily exposure to identify the potential presence of toxins that could have an effect on the genetic material of cells.

Genotoxicity tests are designed to detect substances that could cause genetic damage via either gene mutations or chromosomal damage and must adhere to the International Organization for Standardization’s “Tests of Genotoxicity, Carcinogenicity, and Reproductive Toxicity” as outlined in ISO 10993-3.


Any medical device hoping to head to market 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 and ensures that the device can perform its job in various environments. TÜV SÜD’s laboratories perform a variety of in vitro test methods to ensure that the end product is not going to cause harm in any way, including genotoxicity testing and evaluation.

The ISO 10993 standard requires a structured biological evaluation plan within a risk management process. TÜV SÜD can assist with the biological evaluation plan generation, toxicological risk assessment, and the conclusive biological evaluation report to help your device meet the risk requirements of the standard.


TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory frameworks worldwide. Our expert team offers a comprehensive biocompatibility testing panel for medical devices, including genotoxicity assessment, all conducted in our state-of-the-art laboratories located across the globe.

By helping to address medical manufacturers’ needs in determining and understanding the chemical characterization process and testing outcomes, TÜV SÜD acts as an instrumental partner in ensuring regulatory compliance for organizations of all sizes. We provide end-to-end assistance with efficient use of resources while ensuring that project timelines are met with predictability and diligence.


TÜV SÜD offers complete biocompatibility testing solutions for medical devices through our state-of-the-art laboratories and expert team of medical doctors, engineers, and toxicologists located all across the globe.

  • Genotoxicity - ISO 10993-3 & FDA: Genotoxicity tests are required to identify the presence of toxins that can impact the genetic material of cells. Since no single test can detect all genotoxins, we recommend the following two in vitro tests be conducted:
  • 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:
  1. 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.


  2. 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 test that gives information of DNA damage through structural changes that are called as aberration.


  3. 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 result of DNA damage. It may contain chromosome fragments as a result of DNA breakage or whole chromosomes. This test is able to provide information on clastogenicity and Anuegenecity.


TÜV SÜD is globally recognized and trusted for its quality and safety as a third-party one-stop testing provider. We offer a suite of testing services required for medical devices and help manufacturers and suppliers meet global regulatory standards independently.

  • Globally- Recognized Medical Device Expertise - TÜV SÜD is a trusted partner with dedicated teams of global experts who are committed to helping your organization manage risks and bring the safest medical device possible to the market. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognized by regulatory authorities worldwide for its extensive experience with all types of medical devices.
  • Risk Management Expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 10993-3 and ISO 14971 and conduct thousands of in-depth risk management audits each year. Our TÜV SÜD laboratories are fully ISO 17025 accredited, and our US labs are also able to perform testing under Good Laboratory Practices (GLP).
  • Active Involvement in Standards Development and Implementation - TÜV SÜD takes 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 consortiums. With these initiatives, we go beyond regulatory compliance to inspire trust in a physical and digital world.
  • Single Source Solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations.
  • Other Testing and Certification Services - In addition to biocompatibility assessments required for medical devices, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.


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