Bioburden determination on Medical Devices - General considerations

As defined by the ISO 11737-1 a sterile medical device is one that is free from viable microorganisms. Medical devices produced under standard conditions are allowed to have microorganisms on them and must undergo a sterilisation process before they can be brought to the market for use. The success of the sterilisation process is challenged by the microbial load of the non-sterile product, the “bioburden”.

Therefore, knowing the number and the identity of microorganisms on non-sterile products is an important step on the way to a safe final product.

The webinar "Bioburden Determination on Medical Devices - General Considerations" is mainly based on the content of ISO 117371-1 and aims at participants who want to acquire or refresh basic knowledge on the subject “bioburden determination”. Special attention will be paid on the way how bioburden determination can be performed in general and what the possibilities of product-specific method validation are.