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AAMI TIR52:2014/(R)2022

Environmental monitoring for terminally sterilized healthcare products
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AAMI TIR52:2014/(R)2022

Environmental monitoring for terminally sterilized healthcare products

PUBLISH DATE 2014
AAMI TIR52:2014/(R)2022
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR52
Publication Date Jan. 1, 2014
Language en - English
Page Count 23
Revision Level
Supercedes
Committee
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