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Most recent
AAMI TIR52:2014 (R2022)
Environmental monitoring for terminally sterilized healthcare products
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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]