AAMI TIR29:2002

Guide for process control in radiation sterilization

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

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This technical information report provides additional guidance for establishing and meeting theirradiator dose mapping, process qualification, and routine control requirements for radiationsterilization as defined in ANSI/AAMI/ISO 11137 for gamma and electron beam sterilization.Although bremsstrahlung irradiation has similar requirements, there is little experience in thedesign 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 Information

Published: 11/01/2002
Pages: 37
File Size: 1 file , 620 KB
Language: English
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AAMI TIR29:2012/(R)2017
AAMI TIR29:2002

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