超声波 实时脉冲回波系统 确定性能规格的测试程序

[中文适用范围]： 本文件描述了在0.5 MHz至23 MHz频率范围内测量实时医用超声成像设备性能的代表性方法。 注：给出的频率范围通常代表出版时医院广泛使用的范围；特殊医疗应用使用更高频率进行成像，但主要用于研究或临床前成像。 本文件适用于基于脉冲回波原理的实时超声扫描仪，适用于以下类型： • 机械扇形扫描仪； • 电子相控阵扇形扫描仪； • 电子线性阵列扫描仪； • 电子弯曲阵列扇形扫描仪； • 基于上述四种扫描机制中的任何一种的水浴扫描仪； • 平面波/快速成像扫描仪； • 上述几种方法的组合（例如，线性阵列在边缘相位化以产生扇形以扩大视野。 所描述的方法基于以下评估： • 通过扫描组织模拟物体（体模）获得的声像图； • 通过扫描合适环境中的人工低反射或高反射目标获得的声像图； • 由被测扫描仪传输的超声场参数。 本文件不涉及测量扫描仪电子系统电气参数的方法。 [外文原描述]： IEC TR 61390:2022 describes representative methods of measuring the performance of complete real-time medical ultrasonic imaging equipment in the frequency range 0,5 MHz to 23 MHz. This document is relevant for real-time ultrasonic scanners based on the pulse-echo principle, for the types listed below: - mechanical sector scanner; - electronic phased array sector scanner; - electronic linear array scanner; -electronic curved array sector scanner; - water-bath scanner based on any of the above four scanning mechanisms; - plane-wave/fast imaging scanners; - combination of several of the above methods (e.g. a linear array phased at the edge to produce a sector there to enlarge the field of view. The methods described are based on evaluation of: - sonograms obtained by scanning of tissue mimicking objects (phantoms); - sonograms obtained by scanning of artificial, low- or highly reflective targets in suitable environments; - parameters of the ultrasound field transmitted by the measured scanner. This document does not relate to methods for measuring electrical parameters of the scanner’s electronic systems. IEC TR 61390:2022 cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) Several additional phantom designs are included in the main body of the document; b) Several additional transducer types are included in the Scope; c) Methods of analysis are presented in new Annex B.