ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing

Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on sterilized or sterilizable healthcare products, components or raw materials. Endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods. Excludes determination of pyrogens other than bacterial endotoxins.