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AAMI ANSI/AAMI ST72:2019

Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
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AAMI ANSI/AAMI ST72:2019

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

PUBLISH DATE 2019
AAMI ANSI/AAMI ST72:2019
This standard 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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number ST72
Publication Date Nov. 22, 2019
Language en - English
Page Count 65
Revision Level
Supercedes
Committee
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