What is Genotoxicity testing?

Genotoxicity testing evaluates the biological response of medical device materials according to ISO 10993-3. This testing is required for devices that contact patients to ensure safety and regulatory compliance.

When is Genotoxicity testing required?

Genotoxicity testing is typically required for patient-contacting medical devices as part of the ISO 10993 biocompatibility evaluation. The specific requirements depend on device contact type, duration, and invasiveness.

Genotoxicity Testing (ISO 10993-3)

Complete guide to genotoxicity testing for medical devices. Learn ISO 10993-3 test methods, requirements, and use our tool to find accredited testing labs. Ensure FDA and EU MDR compliance.

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