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AAMI TIR100:2021

End-to-end microbiological quality and sterility assurance

Summary

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 No annex

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2021
Page Count 27
Themes Sterilization—Industrial
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