Know what's inside:
Medical DevicesmdsService / StrategieProducts / Materials

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

Contact us

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

You might also be interested in:

Manufacturing / Monitoring



Seminars / Trainings

© 2023 GBA Group

Follow Us

  • linkedIn GBA Group
  • xing
  • gba youtube
  • gba Instagram
ContactData PrivacyLegal NoticeTerms & ConditionsDisclosure
Phone Phone