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AAMI TIR29:2012/(R)2017

M00002651

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AAMI TIR29:2012/(R)2017 Guide for process characterization and control in radiation sterilization of medical devices

standard by Association for the Advancement of Medical Instrumentation, 12/31/2012

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This technical information report provides additional guidance for characterizing the irradiationprocess and for establishing requisite process controls to ensure the irradiation system remainsin a validated state. This document is intended to complement qualification and routine controlactivities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.