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AAMI TIR29:2012/(R)2017

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

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

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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.
 

Product Details

Published:
12/31/2012
ISBN(s):
1570204772
Number of Pages:
52
File Size:
1 file , 500 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI TIR29:2012/(R)2017

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

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  2. AAMI TIR29:2002


    Guide for process control in radiation sterilization

    • Historical Version