Bioburden and Sterility Test

In SANITER, CE marking works and T.C. Annex-1 of the Ministry of Health Medical Device Regulation The analyzes required to be carried out within the scope of absolute requirements are carried out in accordance with international standards and presented in comprehensive reports.

The main tests performed in this context are bioburden and sterility tests.

Bioburden TEST (Biological Load Amount Test)

It is performed for the purpose of determining the biological load on the products. Even if the products are produced in clean room conditions, they have a certain microorganism load until any sterilization process is applied.

Medical Device Regulation Annex-1: olmayan Packaging systems of non-sterile medical devices; the medical device must be maintained without deterioration, maintaining the prescribed level of cleanliness and minimizing the risk of microbiological contamination if medical devices are to be sterilized before use. ”

In this respect, the determination of the number of microorganisms in medical materials and medical products is performed accredited by TÜRKAK ISO 17025 according to ISO 11737-1 standard.

Sterility Test:

It is performed to determine the sterility control of your products. It is absolutely necessary to check whether the products supplied as sterile on the market are sterile.

Medical Device Regulation Annex-1: “Sterile medical devices should be manufactured and sterilized by a suitable and valid method.”

In this respect, sterility tests of medical materials and medical products are carried out in accordance with ISO 11737-2 accredited under TÜRKAK ISO 17025 in our laboratory