Close this search box.

Testing of biocompatibility

Testing of biocompatibility


The use of biocompatible materials in medical devices guarantees a high level of patient safety. At OFI, we perform biocompatibility tests and skin compatibility tests based on the requirements of ISO 10993.

Implants, prostheses, hearing aids, surgical gloves, menstrual products and many other medical devices are tested at OFI. We have various test methods at our disposal to answer your questions about application safety, material resistance and patient safety.

Biological safety of medical devices

At OFI, we offer analyses within the framework of ISO 10993 (Biological Evaluation of Medical Devices). These are used for product approval. In addition, we support you with contract research in the development and optimization of your products and are involved as scientific experts in a large number of funded, national and international, projects.

All of our testing strategies work without animal testing. In addition to accredited chemical characterization, we also use partially accredited in vitro methods to evaluate cellular changes.


Accredited methods

  • Testing for in vitro cytotoxicity according to ISO 10993-5: Testing for cytotoxicity of sample extracts using L929 mouse fibroblasts. Optical (microscopic) as well as metabolic evaluation (including MTT).
  • Chemical characterization according to ISO 10993-18: Chemical characterization of extracts by HPLC-UV/VIS, HPLC-FLD, HPLC-MS/MS or HPLC-MS-TOF for low volatile substances as well as GC-FID-MS or HS-GC-MS after extraction for high volatile substances. We are also happy to carry out material characterization tests using SEM-EDX or DSC.
  • Test for irritation according to ISO 10993-23: Test for irritation using 3D skin models
  • Sample preparation and reference materials according to ISO 10993-12
    • Tuning of extraction parameters such as time, temperature and solvent
    • Product-dependent surface and gravimetric determinations for compliance with extraction ratios


Non-accredited methods

In-house validated methods for the determination of the sensitizing potential of sample extracts based on ISO 10993-10 and OECD TG 442C, D:

  • DPRA: by an HPLC based method the degradation of two amino acids is determined (coverage of key event 1)
  • MDA-ARE: cell culture-based test for the investigation of potential triggers of allergic reactions (coverage of Key Event 2)
  • Corrosion based on OECD TG 431: test for corrosion using 3D skin models


Additionally, we offer

  • Risk analysis based on existing literature (e.g.: recipe evaluation)

OFI Expert for Medical Devices & Hygiene

DI Gabriele Ettenberger-Bornberg, BA

OFI Expert for Medical Devices

DI Dr. Elisabeth Mertl
You might also be interested in
A selection of projects from this area


Forschungsprojekt AeroMobil
Development of an innovative modular mobile test facility for modeling the microbiological efficiency of air purification under real conditions ...
Establish the scientific basis for safety evaluation of menstrual products. ...
Autonomer Hygieneroboter zur Desinfektion von Oberflächen in Gesundheitseinrichtungen
Development of autonomous, intelligent hygiene robots that use UV/LED to reduce infection germs. ...
Sujetbild Forschungsprojekt E-Steril
Investigation of an autonomous, self-regenerating air filter ...
Hanf als Werkstoff nutzen
Material properties of hemp: Optimization of the natural bactericidal, virucidal and fungicidal effect of hemp fibers. ...