What is Biocompatibility?
In biotechnology, materials that have no negative influence on their metabolism in direct contact with living tissues are called biocompatible. Biocompatibility is particularly significant in implantology. Since medical devices and implants are in direct contact with the surrounding tissue over a long period of time, they must not cause any immune system responses. According to the Medical Devices Act, medical devices must undergo comprehensive testing before being distributed on the market for the protection of patients.
How is it tested?
E. g. you want to produce an implant that consists of an alloy or carries a coating that has not been used so far? We test your products according to biocompatibility according to ISO 10993 and check if the material is bioinert and does not effect damage to the surrounding tissue.
We offer standard tests for biocompatibility:
- Genotoxicity, carcinogenicity, reproductive toxicity (according to DIN EN ISO 10993-3)
The genotoxicity test (Ames test) represents an established method for testing the mutagenic potential of the test object. The mutagenicity can be deduced from the return mutation rates of specific Escherichia coli strains. Here, an extract is produced from the test object and supplied to this E. coli. When the E. coli mutates again on a selective agar, the degree of mutagenicity can be deduced from the number of Colony Forming Units (CFU).
- Cytotoxicity (according to DIN EN ISO 10993-5)
For the test for cytotoxicity, an extract of the test object is supplied to mammalian cells. Based on the optical density and color intensity of the MTT test, the influence of the extract on cell growth can be derived. The lower the OD value (optical density) and the weaker the color of the MTT test, the higher is the cytotoxicity.
- Hemocompatibility (according to DIN EN ISO 10993-4)
The blood compatibility assessment is performed in vitro with human blood. In this case, the test object is brought into contact with the blood, then the changes in the blood picture are, such as platelets and leukocytes, are determined. Tests with whole blood or blood plasma are possible.
- Pyrogenicity / endotoxins (according to DIN EN ISO 10993-11)
Endotoxins are part of the cell membrane of gram-negative bacteria and are released when the organisms die or the cell wall dissolves. They are very heat stable and can not be removed by sterilization. They belong to the so-called pyrogens and can cause fever reactions, low blood pressure, coagulation disorders and life-threatening shock states in even the lowest concentrations in both humans and animals.
Because of this, it is extremely important, especially for medical devices, to ensure endotoxin-free production of the products and packaging. According to the European Pharmacopoeia (Ph. Eur. 2.6.14), medical devices must be checked upon endotoxins, for medical devices <20 EU per product are considered as standard. For the quantitative determination the so-called chromogen-kinetic limulus amoebocyte lysate test (LAL test) is used inter alia.
Why choose us?
We are a certified laboratory with many years of experience in the testing of medical devices and are happy to carry out the required biocompatibility tests on your medical devices for you. We test all types of sterile and non-sterile products in accordance with DIN EN ISO 10993. Through Germany-wide interlaboratory tests, we have already repeatedly proven our correct operation.