Test of Biological Load Amount
It is carried out in order to detect the biological bacterial load on your products.
Medical Device Regulation Annex-1:" Packaging systems of non-sterile medical devices shall be such as to maintain the prescribed level of cleanliness of the medical device without deterioration, and to minimize the risk of microbiological contamination if medical devices are to be sterilized prior to use."
Bioburden Analysis is included in our Türkak accreditation scope.
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