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现行 AAMI TIR104:2022
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Guidance on transferring health care products between radiation sterilization sources 关于在辐射灭菌源之间转移医疗保健产品的指南
发布日期: 2022-04-19
TIR104的重点是为管理医疗保健产品从一种辐射灭菌模式转移到另一种或从一个辐射器转移到使用相同辐射模式的另一个辐射器的过程提供指导。具体的辐射形式有伽马射线、电子束和X射线。本TIR中的指南涉及:变更评估;评估辐射源之间的差异;灭菌和验证剂量的评估;以及最大可接受剂量的评估。
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.
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