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AAMI TIR100:2021

End-to-end microbiological quality and sterility assurance

This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality and Sterility Assurance (MQ and 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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Association for the Advancement of Medical Instrumentation [aami]

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