AAMI TIR106:2024

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Microbiological methods—Understanding and use of product bioburden data

Association for the Advancement of Medical Instrumentation , 03/21/2024

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This document provides guidance regarding the understanding and use of product bioburden data including: what bioburden data represent; how to use bioburden data to support a sterilization process; the analysis and characterization of bioburden; establishment and the use of alert and action levels; how to investigate bioburden excursions; trending and maintaining an effective bioburden monitoring program; counting plates and recording results.