AAMI ST72:2002/(R)2010 PDF

AAMI ST72:2002/(R)2010 PDF

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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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Description

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.

Product Details

Published:
09/01/2002
ANSI:
ANSI Approved
Number of Pages:
34
File Size:
1 file , 230 KB
Part of:
AAMI STBK10-3
Note:
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