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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 |
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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) |