Products / Materials

Qualification of biocompatibility – ISO 10993

We test and evaluate the biocompatibility of medical devices

• Product-specific and application-based selection of qualification strategy and testing procedures

• Biological and chemical characterization of the solubility profile, organic and inorganic leachable and extractable substances/impurities of materials and products: inter alia cytotoxicity testing, chemical analysis GC-MS/GC-FID/HS-GC (VOC, SVOC)/LC-HRMS (NVOC), ICP-MS (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)

• Additional investigations after product storage, processing/repeated processing of products for the proof of biocompatibility over the whole life-cycle of a medical device

• 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