In order to be exported especially to Europe, medical materials must have the "CE" expression.The CE mark can be obtained after the "CE inspection" made by the companies authorized in this regard.
In CE audits, one of the most important requirements for medical products is the bioburden and sterility analysis of the products.
The Bioburden test is a test performed to determine the biological load on the products.
With this test, the "total microbiological load" on the medical products before the sterilization process is determined.
This load is especially important in terms of determining the sterilization dose. Therefore, manufacturers of medical products should know the bioburden level of their products at the end of production.
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