Qualification of biocompatibility – ISO 10993

We test and evaluate the biocompatibility of medical devices

• Product-specific and application-based selection of strategy and testing procedures
• Biological and chemical characterization of the solubility profile,
  organic and inorganic leachable and extractable substances/impurities of materials and products (cytotoxicity testing, chemical analysis GC-MS, GC-FID, ICP-MS et. al.)
  (ISO 10993-1, -3, – 5, -7, -10, -11, -12, -13, -14, -18)
• Corrosion stability of metallic materials,
  electrochemical testing, immersion (ISO 10993-1, -15)
• Hemocompatibility (ISO 10993-1, -4)
• Biostability of implants (ISO 10993-1, -6, -13, -15, -18)
• Summarized evaluation of biocompatibility,
  toxicological risk management (ISO 10993-1, -17), under consideration of the characteristics and toxicological profile of the materials used, released substances, data from literature and experience with the application
• Additional proof of biocompatibility after product storage, processing/repeated processing of products

If you seek efficient and safe qualification of your product, please contact us at