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AAMI TIR29:2012

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

This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization. NOTE - This TIR is intended to be used in conjunction with ANSI/AAMI/ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Because a TIR is considered ôinformativeö and is not subject to the same formal approval process as a standard, the process steps are described in the TIR as ôshouldö rather than ôshall.ö Readers are reminded that many of this TIRÆs ôshouldsö are ôshallsö in ANSI/AAMI/ISO 11137-1

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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