AAMI ST72:2019 ✓ Most Recent

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

standard by Association for the Advancement of Medical Instrumentation , 11/01/2019

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Specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.

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. See more

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Document History

  1. AAMI ST72:2019

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    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


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

    • Historical Version

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Product Details

Published:

11/01/2019

ISBN(s):

9781570207310

ANSI:

ANSI Approved

Number of Pages:

65

File Size:

1 file

Note:

This product is restricted and cannot be purchased in the following countries Belarus, Russia, Ukraine