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AAMI TIR100:2021

End-to-end microbiological quality and sterility assurance
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AAMI TIR100:2021

End-to-end microbiological quality and sterility assurance

PUBLISH DATE 2022
AAMI TIR100:2021
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. Approved by AAMI: 1 October 2021 Pages: 27
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR100
Publication Date May 10, 2022
Language en - English
Page Count 27
Revision Level
Supercedes
Committee
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