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GBA MDS - 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

  • 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.

Contact us

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

info-20@mdservices.de

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GBA MDS - Cytotoxicity of medical devices

Cytotoxicity of medical devices

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