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AAMI TIR52:2014/(R)2022

Environmental monitoring for terminally sterilized healthcare products

Summary

This Technical Information Report (TIR) assists in establishing an environmental monitoring program that is meaningful, manageable and defendable, and provides guidance to avoid adverse environmental conditions during the manufacture of terminally sterilized healthcare products. The objective of this TIR is to provide guidance on the routine monitoring for viable and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized. No annex

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2014
Confirmation Date 01/01/2022
Page Count 0
Themes Sterilization—Industrial
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No products.