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AAMI ST 72:2011 (R2016)

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AAMI ST 72:2011 (R2016)

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

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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. Excludes determination of pyrogens other than bacterial endotoxins.

Author AAMI
Editor AAMI
Document type Standard
Format File
Confirmation date 2016-06-09
ICS 07.100.01 : Microbiology in general
Replace ANSI/AAMI ST 72 (2002)
Year 2011
Document history ANSI/AAMI ST 72 (2011)
Country USA
Keyword ANSI 72;ANSI/AAMI 72;72;ANSI/AAMI ST72-2011 (R2016)