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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.

Product Details

Published:

12/22/2011

ISBN(s):

1570204268

ANSI:

ANSI Approved

Number of Pages:

51

File Size:

1 file , 750 KB