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Bioburden and Sterility Tests in Medical Products

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  • Bioburden and Sterility Tests in Medical Products

The test carried out to determine the biological load on the products is called bioburden test.

With this test, the microbiological load on the medical products is detected before the sterilization process.

n particular, the amount of biological load in medical products is important to determine the sterilization dose.

It is carried out by our laboratory within the scope of "TÜRKAK ISO 17025" and accredited according to "ISO 11737-1" standard.

It is absolutely necessary to test whether medical products should be placed on the market sterile or not. In this sense, the test to be performed is "sterility test".

According to Medical Device Regulation Annex-1, sterile medical devices must be manufactured and sterilized with a suitable and valid method. For this reason, products to be sold sterile must be subjected to sterility testing.

Both bioburden and sterility testing are carried out accredited in our laboratory.


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