AAMI ST72:2002/(R)2010

Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) onmedical devices, components, or raw materials. Bacterial endotoxin methodologies coveredinclude both qualitative (limit) methods and quantitative (end-point) methods using Limulusamebocyte lysate methodology. Determination of pyrogens other than bacterial endotoxins is notcovered and acceptable levels for bacterial endotoxins are not covered.