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AAMI TIR29:2012 (R2017)

Guide for process characterization and control in radiation sterilization of medical devices

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

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Association for the Advancement of Medical Instrumentation [aami]

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