AAMI TIR100: 2021

End-to-end microbiological quality and sterility assurance

Association for the Advancement of Medical Instrumentation , 05/10/2022

Publisher: AAMI

File Format: PDF

$94.00$189.00


This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality & Sterility Assurance (MQ&SA) into an organization's end-to-end process for the development, validation, and routine control of sterile health care products.

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