AAMI ST72:2011/(R)2016

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

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

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 12/22/2011

Published:12/22/2011

Pages:51

ISBN(s):1570204268

File Size:1 file , 750 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.