This recommended practice 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. The recommended practice excludes determination of pyrogens other than bacterial endotoxins.
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AAMI ST72:2011/(R)2016
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Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
Association for the Advancement of Medical Instrumentation , 12/22/2011
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