Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
|Publication Date:||1 January 2011|
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods.
NOTE Although the scope of this standard is limited to medical devices, it also includes requirements and provides guidance that may be applicable to other health care products.
This document is not applicable to the evaluation of pyrogens other than bacterial endotoxin.