超声学.物理治疗系统.频率范围为0.5MHz至5MHz的现场规范和测量方法

[中文适用范围]： 本文件适用于设计用于物理治疗的超声设备，该设备包含一个在0.5 MHz至5 MHz频率范围内产生连续或准连续（例如音爆）波超声的超声换能器。本文件仅涉及每个治疗头使用单个平面非聚焦圆形换能器，产生垂直于治疗头表面的静态束的超声物理治疗设备。 本文件规定了： 基于参考测试方法的超声物理治疗设备输出的测量和表征方法；基于参考测试方法的超声物理治疗设备制造商应指定的特性；超声物理治疗设备产生的超声场安全指南；基于常规测试方法的超声物理治疗设备输出的测量和表征方法；基于常规测试方法的超声物理治疗设备输出的接受标准。 超声物理治疗设备的治疗价值和使用方法不在本文件的范围内。 使用20 kHz至500 kHz频率范围内超声的超声物理治疗设备在IEC 63009中处理。 [外文原描述]： IEC 61689:2022 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 61689:2022 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 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 based on reference testing methods; - guidelines for safety of the ultrasonic field generated by 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 based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document. Ultrasonic physiotherapy equipment using ultrasound in the frequency range from 20 kHz to 500 kHz is dealt with in IEC 63009. IEC 61689:2022 cancels and replaces the third edition published in 2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition. a) The requirement on water oxygen content is specified in 6.1. b) Former recommendations in 6.2 have been changed to become requirements. c) Several definitions in Clause 3 have been updated in line with other TC 87 documents. d) The formerly informative Annex A has been changed to become normative, and now contains details on how conformance with IEC 60601-2-5 requirements is checked. e) Annex D has been considerably shortened and reference to a now withdrawn regulatory document has been removed.