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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