超声波 物理治疗系统 20 kHz 至 500 kHz 频率范围内的现场规范和测量方法

[中文适用范围]： 本国际标准适用于设计用于物理治疗的超声波设备，包含产生频率范围为20 kHz至500 kHz的超声波换能器。 本文件仅涉及每个治疗头采用单个平面非聚焦圆形换能器的超声波物理治疗设备，产生垂直于治疗头表面的静态光束。 本文件规定了： • 基于参考测试方法的超声波物理治疗设备输出的测量和表征方法； • 超声波物理治疗设备制造商应指定的特性； • 基于常规测试方法的超声波物理治疗设备输出的测量和表征方法； • 超声波物理治疗设备输出方面的验收标准。 超声波物理治疗设备的治疗价值和使用方法不在本文件范围内。 排除的设备包括但不限于： • 旨在破坏结石（例如肾脏或膀胱中的结石）或任何类型组织的设备； • 由超声波驱动的工具（例如手术刀、超声乳化器、牙科洁牙机或体内碎石机）； • 旨在使组织对其他治疗（例如放射或化疗）敏感的超声波设备； • 旨在治疗癌症（即恶性）或癌前组织或良性肿块的超声波设备，例如高强度聚焦超声（HIFU）或高强度治疗超声（HITU）。 [外文原描述]： IEC 63009:2019 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. This document only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This document specifies: • methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods; • characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment; • methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; • acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment. The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document. Excluded equipment includes, but is not limited to: • equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type; • equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters); • equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy); • equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).