Bioburden Test

 

It is carried out to determine the biological bacterial load on medical products. 

Medical device regulations require that the packaging systems of non-sterile medical devices be maintained in a manner that maintains the prescribed cleanliness level without deterioration of the medical device and minimizes the risk of microbiological contamination if the medical devices are to be sterilized before use. 

Bioburden test is carried out in accordance with TS EN ISO 11737-1 standard.