What is Chemical Characterization testing?

Chemical Characterization testing evaluates the biological response of medical device materials according to ISO 10993-18. This testing is required for devices that contact patients to ensure safety and regulatory compliance.

When is Chemical Characterization testing required?

Chemical Characterization 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.

Chemical Characterization Testing (ISO 10993-18)

Complete guide to chemical characterization for medical devices. Learn ISO 10993-18 test methods, extractables and leachables testing, and use our tool to find accredited testing labs. Ensure FDA and EU MDR compliance.

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