AAMI ST72:2002/(R)2010

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

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

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 09/01/2002

Published:09/01/2002

Pages:34

File Size:1 file , 230 KB

Language:English

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

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.