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ANSI/AAMI/ISO 11737-3:2023
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.
Association for the Advancement of Medical Instrumentation [aami]