ANSI/AAMI ST72:2019

ANSI/AAMI ST72:2019

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

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Details

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. No annex

Zusätzliche Information

Autor Association for the Advancement of Medical Instrumentation (AAMI)
Veröffentlicht von AAMI
Document type Normen
Thema Sterilization - Industrial
EAN ISBN 9781570207310
ICS 07.100.01 : Mikrobiologie im Allgemeinen
Seitenzahl 65
Ersetzt AAMI ST72:2011/(R)2016,AAMI ST72:2002/(R)2010
angepasst von Includes Erratum (2020)
Schlagwort ANSI/AAMI ST72:2019
ANSI Approved