Preview

AAMI TIR29:2012/(R)2017

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

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

$130.00 $259.00

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.