超声波——治疗用聚焦短压力脉冲源-特性

[中文适用范围]： IEC 61846:2025适用于： – 使用体外诱导集中压力脉冲波的治疗设备； – 产生集中机械能量（不包括热能）的治疗设备。 本文件不适用于经皮和激光碎石设备。 本文件不适用以下内容： – 历时比压力脉冲长的高强度聚焦超声或其它治疗方法； – 非集中压力脉冲设备。 本文件规定了： – 可用于声明体外集中压力脉冲波治疗设备声输出的可测量参数； – 测量和表征集中压力脉冲设备生成的压力场的方法。 尽管本文件是为碎石用途而开发的，但鉴于没有其他特定标准可用于其它医疗应用的体外集中压力脉冲波治疗设备，只要没有其他适用的标准，本文件也可作为指导性文件使用。 IEC 61846:2025取消并替代了于1998年首次发布的第一版。本版构成技术修订。 与上一版本相比，本版包含以下重要的技术变更： a) 标题更改：“前一版的‘压力脉冲碎石器’”标题更改为“治疗性集中短压力脉冲源”，以反映此类源在相关技术及生物医学应用中的发展情况。这些装置最初仅用于（肾）碎石，而最近的应用范围包括多种疾病的治疗，例如结石病、骨科疼痛、组织、心脏和大脑疾病。 术语“集中”被添加进来以区分IEC 61846与IEC 63045标准。 术语“短”被添加进来以便使命名与IEC 63045相一致，并将IEC 61846与HIFU和HITU领域的标准区分开来。 b) 第1条及其他部分：将“碎石术”一词更改为“治疗”，以反映超出结石病之外的广泛应用范围。 c) 第3条：“−6 dB”参数定义被替换为“−n dB”，以避免对这些参数的重要性和用途产生误解，并考虑到文献中的最新发现。 同样原因还引入了更多的“n MPa”参数。 衍生参数的定义与最近发布的标准（例如IEC 62127-1）保持一致。 增加了描述出现在较新相关文献中的参数的定义，例如“动量”、“平均正向声压”、“气泡诱导指数”、“脉冲间变异性”、“总压力脉冲能量剂量”。 d) 第6条：移除了“焦点水听器”和“场水听器”的术语，以反映最新的技术进步。新术语区分了“用于测量压力脉冲的水听器”与“用于质量保证的水听器”。 e) 附录：描述、表格和图示经过编辑，以考虑新的文献和技术发展。 [外文原描述]： IEC 61846:2025 is applicable to: – therapy equipment using extracorporeally induced focused pressure pulse waves; – therapy equipment producing focused mechanical energy excluding thermal energy. This document does not apply to percutaneous and laser lithotripsy equipment. This document does not apply to: – histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the pressure pulse; – non-focused pressure pulse equipment. This document specifies: – measurable parameters which could be used in the declaration of the acoustic output of extracorporeal focused pressure pulse equipment; – methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment. While this document has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal focused pressure pulse equipment, this document can be used as a guideline. IEC 61846:2025 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) Change of title: "pressure pulse lithotripters" in the previous edition is changed to "therapeutic focused short pressure pulse sources" in order to take into account the development in the relevant technical and biomedical applications of such sources, which were originally used only for (kidney) lithotripsy, while recent applications include a wide range for the treatment of, for example, stone diseases, orthopaedic pain, tissue, cardiac and brain diseases. The term "focused" was added to differentiate IEC 61846 from IEC 63045. The term "short" was added to align the nomenclature to IEC 63045 and to differentiate IEC 61846 from standards in the HIFU and HITU fields. b) Clause 1 and elsewhere in the document: The term "lithotripsy" is changed to "therapy" in order to account for the wide range of applications beyond stone diseases. c) Clause 3: The "−6 dB" parameter definitions are replaced by "−n dB" to avoid misconceptions in the significance and use of these parameters and to account for newer findings in literature. Additional "n MPa" parameters are introduced for the same reasons. The definitions of "derived" parameters are aligned to those in recently published standards, for example IEC 62127-1. New definitions were added which describe parameters appearing in newer relevant literature, for example "momentum", "average positive acoustic pressure", "cavitation induction index", "pulse to pulse variability", "total pressure pulse energy dose". d) Clause 6: The terms "focus hydrophone" and "field hydrophone" were removed to account for newer technical developments. New terms distinguish between "hydrophones for pressure pulse measurements" and "hydrophones for quality assurance". e) Annexes: Descriptions, tables and figures were edited to account for newer literature and standards as well as technical developments.