超声学-外科系统-基本输出特性的测量和声明

[中文适用范围]： IEC 61847:2025 规定了以下内容：– 超声手术设备的基本非热输出特性；– 测量这些输出特性的方法；– 制造商需声明的设备特性。本文件适用于满足以下a)、b)和c)项标准的设备：a) 在20 kHz至120 kHz频率范围内运行的超声手术系统；b) 用于人体组织的碎裂、乳化、清创或切割的超声手术系统，无论这些效果是否与组织移除或凝固同时进行；c) 通过特定设计的波导传输声波，将能量传递至手术部位的超声手术系统。本文件不适用于以下设备：– 使用体外诱导压力脉冲、通过液体传导介质和软组织聚焦的碎石设备；– 作为治疗过程一部分使用的手术系统（如热疗系统）；– 通过波导与组织接触时产生的摩擦热进行作用的手术系统，如夹持凝固器或夹持振动切割器；– 通过聚焦超声波进行远程组织热降解（高强度聚焦超声 – HIFU或HITU）或空化侵蚀（Histotripsy）的手术系统；– 通过与应用器尖端接触的硬组织磨损进行作用的手术系统，如骨切割或钻孔。本文件不涉及超声手术系统的有效性或安全性。本文件不涉及系统产生的空气噪声，这些噪声可能影响操作者和患者。IEC 61847:2025 取代并替换了1998年首次发布的版本。本版为技术修订版。与前一版相比，本版包含了以下重大技术变更：a) 本文件涵盖的最高频率从60 kHz提高至120 kHz；b) 超声波功率的水听器测量方法现在成为标准方法。由于使用热量计法测量超声波功率存在困难，该方法不再作为首选方法；c) 一些系统在用户控制下可能具有多种振动模式，因此测量技术和声明已相应更新；d) 针对与应用器尖端处空化现象相关的高频成分以及空化发生时的振动幅度进行了说明；e) 描述了在无空化现象的位移水平进行测量以及外推到最大位移水平的要求；f) 提供了将所述方法应用于更复杂设计、振动模式、位移方向及其输出特性的指导；g) 提供了针对不同类型系统的测量水箱布置的指导；h) 扩展了未涵盖的超声波方法和系统的列表，以包括最近的发展；i) 增加了与空化相关的术语定义；j) 改变了应用器尖端方向特性测量的要求；k) 附件A进行了修改，并添加了图A.1；l) 新增了文献，并更新了对其他标准的引用。 [外文原描述]： IEC 61847:2025 specifies: – the essential non-thermal output characteristics of ultrasonic surgical units; – methods of measurement of these output characteristics; – those characteristics to be declared by the manufacturers of such equipment. This document is applicable to equipment which meets the criteria of a), b) and c) below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site. This document is not applicable to: – lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body; – surgical systems used as part of the therapeutic process (hyperthermia systems); – surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters; – surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer; – surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling. This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients. IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz. b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach. c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this. d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed. e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described. f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics. g) Guidance is provided with respect to measurement tank arrangements for different types of systems. h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments. i) Definitions for cavitation related terms were added. j) Requirements for the measurement of directivity characteristics of the applicator tip were changed. k) Annex A was modified and Figure A.1 was added. l) New literature was added, and the references to other standards were updated.