Products / Materials
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
Material characterization of the solubility profile, organic and inorganic leachable and extractable constituents/impurities of materials and products and from manufacturing processes: chemical characterization by means of GC-MS, GC-FID, ICP-MS (ISO 10993-1, -3, -7, -9, -10, -11, -12, -13, -14, -15, -18, -23)
Cytotoxicity (ISO 10993-1, -5, -12)
Sensitization (ISO 10993-1, -10, -12)
Irritation (ISO 10993-1, -12, -23)
Acute systemic toxicity (ISO 10993-1, -11, -12)
Hemocompatibility (ISO 10993-1, -4, -12)
Genotoxicity in vitro and in vivo (ISO 10993-1, 3, -12)
Corrosion stability of metallic materials, identification and quantification of degradation products by means of electrochemical and immersion testing (ISO 10993-1, -9, -15)
Biostability of implants (ISO 10993-1, -6, -13, -15, -18)
Summarized evaluation of biocompatibility including toxicological risk assessment (ISO 10993-1, -17), under consideration of the characteristics and toxicological profile of the materials used and of released constituents, data from comprehensive literature search and experience with clinical device application
Additional proof of biocompatibility over the whole life-cycle of a medical device after product storage (accelerated and real-time ageing) and processing/repeated processing of products.
