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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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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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