三维超声成像性能试验方法解析  

Analysis of Performance Test Methods for Three-Dimensional Ultrasonography

作　　者：柯钢 李思进 白鸽 轩辕韵佳 吴成志 刘萌萌 KE Gang;LI Si-jin;BAI Ge;XUANYUAN Yun-jia;WU Cheng-zhi;LIU Meng-meng(Hubei Medical Device Quality Supervision and Test Institute,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2022年第1期20-23,共4页China Medical Device Information

基　　金：国家重点研发计划项目(项目名称:乳腺三维超声容积成像系统及面阵探头的研制,项目编号:2016YFC0104800;课题名称:乳腺三维超声容积成像系统检验方法及规范的研究,课题编号:2016YFC0104804)。

摘　　要：三维超声成像分为三维重建超声成像和实时三维超声成像。三维超声成像比二维超声成像能够提供更加丰富的空间信息,在临床上常用于心肌损伤检测、胸腹部体内肿瘤检测、以及妊娠期胎儿体征评估等方面。三维数据采集方法使用到的有自由臂系统、机械定位系统以及二维面阵探头等。三维超声成像的常见性能指标包括探测深度、盲区、侧向分辨力、轴向分辨力、几何位置精度、三维体积重建偏差等。结合医药行业标准YY/T1279-2015对三维超声成像性能试验的具体操作方法进行图示解析,以期对规范注册申请人注册自检工作、确保相关产品医疗器械注册检验工作有序开展中有所帮助。Three dimensional ultrasound imaging is divided into three-dimensional reconstruction ultrasound imaging and real-time three-dimensional ultrasound imaging.Three dimensional ultrasound imaging can provide more abundant spatial information than two-dimensional ultrasound imaging,and is often used clinically for detection of myocardial injury,detection of tumors in the chest and abdomen,and evaluation of fetal signs during pregnancy.The data acquisition methods that have been used include free arm systems,mechanical positioning systems,and two-dimensional area array probes.Common performance indicators of 3D ultrasound imaging include detection depth,blind zone,lateral resolution,axial resolution,geometric position accuracy,and 3D volume reconstruction error.Based on the medical industry standard YY/T1279-2015,this paper illustrated the specific operation methods of three-dimensional ultrasonic imaging performance test.It is hoped that it will be helpful in regulating the registration self-inspection of registration applicants and ensuring the orderly development of the registration and inspection of related products and medical devices.

关 键 词：三维超声 超声诊断 医用电气 性能检测 标准研究 

分 类 号：TH772[机械工程—仪器科学与技术]