Biocompatibility of Medical Devices

The products offered by the medical device sector are subject to various biocompatibility regulations, depending on the intended application and complexity of the device.

We carry out a wide range of laboratory tests to ensure the quality and safety of medical devices in compliance with applicable harmonized standards. Our team of experts can also develop and validate methods for all requirements related to medical devices.

• Cytotoxicity test – UNI EN ISO 10993-5
• Acute systemic toxicity test – UNI EN ISO 10993-11
• Skin sensitization test – GPMT – UNI EN ISO 10993-10
• In vitro dermal absorption test – OECD 428
• Intracutaneous reactivity test – UNI EN ISO 10993-10
• Acute eye irritation test – UNI EN ISO 10993-10
• Skin irritation test – UNI EN ISO 10993-10
• Nasal mucosa irritation test – UNI EN ISO 10993-10
• Oral mucosa irritation test – UNI EN ISO 10993-10
• Penile mucosa irritation test – UNI EN ISO 10993-10
• Rectal mucosa irritation test – UNI EN ISO 10993-10
• Vaginal irritation test – UNI EN ISO 10993-10
• Hemocompatibility test – UNI EN ISO 10993
• Subchronic toxicity and implantation test – UNI EN ISO 10993
• Bacterial reverse mutation test (Ames test) – OECD 471
• In vitro mammalian cell micronucleus test – OECD 487
• In vivo mammalian erythrocyte micronucleus test – OECD 474
• In vitro mammalian cell gene mutation test using thymidine kinase gene – OECD 490