超声学. 场特性. 高强度治疗性超声(HITU)换能器和系统场参数的规范及测量

[中文适用范围]： 本技术规范适用于高强度治疗超声（HITU）设备，规定了：量化场的相关参数；在相对较低输出水平下的测量方法及将这些结果外推至较高治疗水平场的方法；旁瓣和焦前最大值的考虑；适用于不同构造和几何形状的高强度治疗超声换能器的相关参数，包括非聚焦、聚焦（有无透镜）、准直、发散和会聚换能器、多元件换能器、扫描换能器和多源换能器。本技术规范旨在支持IEC 60601-2-62中给出的超声测量要求。这些规范将用于质量保证、安全测试以及关于HITU系统临床性能的沟通标准化。本技术规范不适用于以下类型的设备：碎石术设备（见IEC 61846）；外科手术设备（见IEC 61847）；理疗设备（见IEC 61689）。 [外文原描述]： IEC TS 62556:2014 is a technical specification applicable to high intensity therapeutic ultrasound (HITU) devices. It specifies the relevant parameters for quantifying the field; the measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields; some considerations of sidelobes and pre-focal maxima; and parameters relevant to HITU transducers of different construction and geometry, including non-focusing, focusing with or without lenses, collimated, diverging and convergent transducers, multi-element transducers, scanning transducers and multiple sources. This technical specification is intended to support the ultrasonic measurement requirements given in IEC 60601-2-62. These specifications would have use in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this technical specification incorporates specifications from other related standards. This technical specification does not apply to the following types of devices, which are covered by other standards: lithotripters (see IEC 61846); surgical equipment (see IEC 61847); and physiotherapy devices (see IEC 61689).