Pyrogens are a foreign substance that causes a fever or elevated temperature in a human body. Typically,pyrogenic substances include endotoxin and other bacterial byproducts. Medical devices must be confirmed to be “pyrogen free” to specific levels according to regulatory requirements of medical device directives.
Many products and components produced at Minnesota MedTec are routinely tested based on our customers needs for Pyrogens and our processes are made to accommodate those customers that would like their products tested. We do not test all the processes routinely for pyrogenic substances to reduce the cost for products that don’t need the testing.