In our laboratory, the biocompatibility tests required for the CE certificate or license of Medical Devices are carried out within the scope of OECD GLP.
The tests performed in our laboratory with GLP approval are as follows;
- Chemical Characterization Tests
- Detection and Determination of Degradation Products
- Determination of Ethylene Oxide Residue
- Product Stability
- Particle Size
- Raw Material Purity
- Extractable & Leachable
- Toxicological Risk Assessment
- Cytotoxicity
- Hemocompatibility
- Systemic Toxicity
- Genotoxicity
- Sensitivity Tests
- Irritation Tests
- Subchronic Systemic Toxicity
- Chronic Systemic Toxicity
- Ames Test
- Comet Test
- Pyrogenicity Test
- LD 50 Dose Determination Test
- Irritation Test
- Micronucleus Test
Please contact us for more information about the tests we do on Medical Devices.