Biocompatibility of Medical Devices

LAB Research Denmark offers extensive expertise in medical device testing, including custom-designed testing programs for each device we are asked to assess. With over 20 years of experience in designing programs, our experts take into consideration the various guidelines, the nature and construction of the device, its use, as well as its mode and duration of patient contact.

LAB Research participates actively in the revision process of national and international guidelines, including a number of the ISO 10993 standards. This ensures that we are always aware of current requirements and new directives.

Study types
LAB Research can perform all standard biocompatibility tests. In addition, customized tests can be designed and validated as necessary.

• Cytotoxicity test (in vitro)
• Sensitization test
   Maximization test (GPM), for extracts or fluids
   Buehler test
• Irritation and intracutaneous tests
   Single or cumulative exposure in accordance with the intended clinical use
• Single dose systemic toxicity tests
• Genotoxicity
   Ames test (OECD 471)
   Gene mutation test (OECD 476)
• Implantation test
   Muscle or subcutaneous implantation
• Haemolysis and coagulation tests
   The range of haemocompatibility tests can be very variable and advice can be found in the ISO standards

Specialty services Other types of tests with various mucosal surfaces and species  Buccal cavity  Subchronic and chronic toxicity tests

Implantation of devices Carcinogenicity and reproductive tests Consultancy

Species Rodent Non-Rodent Minipig

Technical capabilities

• All surgical implant procedures are performed by experienced staffs.