The "CE" marking of medical products is of great importance, especially for export. In this sense, "bioburden and sterility test" comes first among the mandatory tests that medical companies must have for "CE certificate".
Bioburden test is the name of the test performed to determine the biological load on the products. With this test, the microbiological load on medical products is determined before the sterilization process.
Especially, in medical products, the amount of biological load is also important in determining the sterilization dose.
Whether or not medical products that need to be put on the market as sterile must be tested whether they are sterile or not.
As mentioned in the "Medical Device Regulation Annex-1", sterile medical devices must be manufactured and sterilized by a suitable and valid method. Therefore, sterility test must be performed on sterile medical equipment.
"Bioburden and Sterility Test" is carried out in our laboratory accredited.
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