AAMI TIR29:2002

Guide for process control in radiation sterilization

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

Publisher: AAMI

File Format: PDF

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Description

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

Published:11/01/2002

Pages:37

File Size:1 file , 620 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.