What is Sensitization testing?

Sensitization testing evaluates the biological response of medical device materials according to ISO 10993-10 / ISO 10993-23. This testing is required for devices that contact patients to ensure safety and regulatory compliance.

When is Sensitization testing required?

Sensitization 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.

Sensitization Testing (ISO 10993-10 / ISO 10993-23)

Complete guide to sensitization testing for medical devices. Learn ISO 10993-10 and ISO 10993-23 test methods, requirements, and use our tool to find accredited testing labs. Ensure FDA and EU MDR compliance.

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