Toxicological Risk Assessment

Toxicological risk assessment is a critical process used to analyze the safety profile of medical devices and understand potential risks to user health. At Oxigen Analysis, our expert toxicologists conduct comprehensive toxicological evaluations and risk analyses to ensure the safety of your devices.

In accordance with the ISO 10993-17 standard, these tests identify and evaluate all toxicity risks and human exposure from the final product and chemical components of medical devices. This process ensures that your devices comply with both regulatory requirements and safety standards.

Test Standards

• ISO 10993-17: Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances.

Oxigen Analysis Laboratory offers reliable and internationally compliant toxicological risk assessment services for your medical devices. Contact us for more information and to request our services.