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About This Item


Full Description

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.

Document History

  1. AAMI TIR29:2012/(R)2017


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

    • Most Recent
  2. AAMI TIR29:2002

    Guide for process control in radiation sterilization

    • Historical Version