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M00001563
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AAMI TIR100: 2021
End-to-end microbiological quality and sterility assurancestandard by Association for the Advancement of Medical Instrumentation, 05/10/2022
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This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality Sterility Assurance (MQSA) into an organization's end-to-end process for the development, validation, and routine control of sterile health care products.