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AAMI TIR29:2002

Guide for process control in radiation sterilization

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.

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