AAMI TIR100: 2021

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End-to-end microbiological quality and sterility assurance

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

Pages: 27

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Category: AAMI

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

Published:05/10/2022

Pages:27

ISBN(s):9781570208379

File Size:1 file , 590 KB

Language:English

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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.