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AAMI ST72:2011/(R)2016

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AAMI ST72:2011/(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

standard by Association for the Advancement of Medical Instrumentation, 12/22/2011

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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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Published: 12/22/2011 ISBN(s): 1570204268 ANSI: ANSI Approved Number of Pages: 51File Size: 1 file , 750 KB
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