GLP-Laboratory
The Institute for Biomedical Engineering operates a GLP certified biomaterials testing laboratory according to ISO 10993. It offers a variety of in vitro biocompatibility assays and in vivo tests in small animal models, in particular for the following parameters: cytotoxicity | hemocompatibility | pyrogenicity | sensitization | irritation | long term implantation | subchronic toxicity | defense reactions | biodegradation.
GLP test scope
Test program for biological tests of medical devices according to EN ISO 10993
1. Physicochemical tests for biological assessment of materials
1.1 Detection of degradation products in polymer materials (EN ISO 10993-13)
- Accelerated degradation test
- Real time degradation test
1.2 Test on pyrogenic substances of endotoxic origin (EN ISO 10993-11)
- Test on pyrogenic substances using the LAL test
2. In vitro tests for biological assessment of materials
- Cytotoxicity assessment of materials using a cell viability assay
- Cytotoxicity assessment of materials using a cell proliferation assay
3. In vivo tests for biological assessment of materials
3.1 Sensitization test: Maximization method (EN ISO 10993-10)
3.2 Acute systemic toxicity (EN ISO 10993-11)
3.3 Subchronical toxicity (EN ISO 10993-11)
3.4 Intramuscular implantation (EN ISO 10993-6)
3.5 Irritation: Intracutaneous (intradermal) reactions (EN ISO 10993-10)
3.6 Test on pyrogenic substances with endotoxical or non-endotoxical origin in rabbits (EN ISO 10993-11)
The test for biological examination of materials acccording to EN ISO 10993 are performed in test laboratories of the University of Rostock, which have a certified quality assurance system according to the good laboratory practice (GLP).