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AAMI ST72:2002/(R)2010

M00011103

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AAMI ST72:2002/(R)2010 Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing

standard by Association for the Advancement of Medical Instrumentation, 09/01/2002

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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.