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About This Item
Full Description
The purpose of this document is to consolidate the requirements and guidance for testing for bacterial endotoxins. This includes product required to be non-pyrogenic due to intended use and non-pyrogenic labelling. Details are also provided on selection of product units, method suitability, use of techniques for routine testing, interpretation of test results, and alternatives to batch testing and risk assessment.
Document History
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AAMI ST72:2019
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Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)- Most Recent
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AAMI ST72:2011/(R)2016
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing- Historical Version
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AAMI ST72:2002/(R)2010
Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing- Historical Version