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AAMI TIR29:2002

Guide for process control in radiation sterilization

standard by Association for the Advancement of Medical Instrumentation , 11/01/2002

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Full Description

This technical information report provides additional guidance for establishing and meeting the irradiator dose mapping, process qualification, and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137 for gamma and electron beam sterilization. Although bremsstrahlung irradiation has similar requirements, there is little experience in the design and operation of a bremsstrahlung irradiation facility at the time of this work was initiated, and therefore the requirements for bremsstrahlung irradiation are not included in the scope.
 

Product Details

Published:
11/01/2002
Number of Pages:
37
File Size:
1 file , 620 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI TIR29:2012/(R)2017


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

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  2. AAMI TIR29:2002

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    Guide for process control in radiation sterilization

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