PET CT整机部件可靠性测试及分析文件

本研究在联影攻关研制国产新一代全数字PET/CT中，为全数字高分辨 PET 探测器核心部件的自主研发及 PET/CT 系统架构集成提供可靠性设计与失效分析工作。完成了关键部件结构可靠性设计工作，使用FMEA方法分析关键部件的失效模式，计算风险顺序数，对后果严重度大于9或者风险顺序数大于100的故障模式提出改进措施。完成了PET探测器HALT测试、CT探测器仿真测试以及CT探测器模块环境测试等，验证了研发的PET探测器和CT探测器等部件的可靠性性能，为改善提高PET/CT可靠性提供了参考。

This study provides reliability design and failure analysis support for the independent development of core components of fully digital high-resolution PET detectors and the system architecture integration of PET/CT, during United Imaging's efforts to develop the domestic new-generation fully digital PET/CT system. We completed the structural reliability design of key components, employed the Failure Mode and Effects Analysis (FMEA) method to analyze their failure modes and calculate the Risk Priority Number (RPN), and proposed improvement measures for failure modes with a severity score greater than 9 or an RPN greater than 100. Additionally, we conducted Highly Accelerated Life Testing (HALT) for PET detectors, simulation testing for CT detectors, and environmental testing for CT detector modules, which verified the reliability performance of the developed PET and CT detector components, and provided a reference for enhancing the overall reliability of the PET/CT system.