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AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources
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The focus of TIR104 is to provide guidance in managing the process for transferring a health care product either from one radiation sterilization modality to another or from one irradiator to another using the same radiation modality. The specific radiation modalities addressed are gamma, electron beam, and X-ray.   Guidance in this TIR relates to:  assessment of change; evaluation of differences between radiation sources; assessment of sterilization and verification dose; and assessment of maximum acceptable dose.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR104
Publication Date April 19, 2022
Language en - English
Page Count 31
Revision Level
Supercedes
Committee
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