Qualification of biocompatibility – ISO 10993

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, reprocessing

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