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Full Description

Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on medical devices, components, or raw materials. Bacterial endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods using Limulus amebocyte lysate methodology. Determination of pyrogens other than bacterial endotoxins is not covered and acceptable levels for bacterial endotoxins are not covered.
 

Document History

  1. AAMI ST72:2019


    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)

    • Most Recent
  2. AAMI ST72:2011/(R)2016


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

    • Historical Version
  3. AAMI ST72:2002/(R)2010

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    Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing

    • Historical Version