Biocompatibility

One focus of OFI is the evaluation of medical device biocompatibility. In accordance with the ISO 10993, a risk-based approach is used to obtain meaningful results and address product-specific requirements.

Our testing expertise includes in vitro testing for cytotoxicity according to ISO 10993-5, skin irritation according to ISO 10993-23 and skin sensitization according to ISO 10993-10, appendix C. Using these validated in vitro assays, animal testing can be avoided and yet safety for the patient ensured. To detect any harmful trace impurities, chemical characterization is performed based on the 10993-18.

This test strategy, together with the expert opinion of our analysts, ensures you can bring a safe medical device to the market.