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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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.

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