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Guide for process characterization and control in radiation sterilization of medical devices
| Published by | Publication Date | Number of Pages |
| AAMI | 12/31/2012 | 52 |
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AAMI TIR29 – Guide for process characterization and control in radiation sterilization of medical devices
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.
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