Testing for biocompatibility

Testing for biocompatibility


The use of biocompatible materials in medical devices guarantees a high level of patient safety. We perform biocompatibility tests as well as tests for skin compatibility and check whether the medical devices also meet all other product-specific additional requirements. In addition to the examination of implants, OFI services also include the inspection of medical protective equipment, such as surgical gloves or protective masks. We can draw on a variety of test methods to answer your questions about application safety, patient safety, retention of pathogenic germs or reprocessing.

Biocompatible materials and products under test

We offer analyses for your product approvals as well as contract research and research within the scope of funded, national and international, projects. To this end, care is taken in the testing strategy to ensure that animal testing is not necessary wherever possible. In addition to chemical characterization, validated in vitro and in-chemico methods are also used.

Chemical characterization of migratable ingredients by HPLC-UV/VIS, HPLC-FLD, HPLC-MS/MS or HPLC-MS-TOF for low volatile substances and GC-FID-MS or HS-GC-MS after extraction for high volatile ingredients. We are also happy to perform material characterization studies using SEM-EDX or DSC.
We would be happy to develop a study design for you to investigate degradable biopolymers such as hyaluronic acid and non-degradable plastics for their degradation and change in molecular mass as well as extractables and leachables. Degradation studies are also needed in the context of drug and compound stability.
If required, validated concentration steps or sample preparation according to product standards (e.g. contact lenses ISO 18369-4)
  • In vitro cytotoxicity according to DIN ISO 10993-5 using L929 mouse fibroblasts, accredited method
  • In vitro skin irritation using an ECVAM validated human 3-D skin model EpiDerm (OECD TG 439).
  • In vitro skin corrosion using an ECVAM validated human 3-D skin model EpiDerm (OECD TG 431).
  • In vitro eye irritation using an ECVAM validated human 3-D skin model EpiOcular (OECD TG 405).
  • DPRA method: testing the ability of a hapten (pro-allergen) to bind to a protein/peptide and elicit an allergic response (OECD TG 442C).
  • ARE: Investigation of the activation of the metabolic pathway that can trigger allergy using dendritic cells (OECD TG 442D).

OFI Expert for Medical Devices & Hygiene

DI Gabriele Ettenberger-Bornberg, BA

OFI Expert for Medical Devices

DI Dr. Elisabeth Mertl
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