IEC 61689:2022 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

标准编号：IEC 61689:2022

中文名称：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

英文名称：Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

发布日期：2022-03-08

标准范围

IEC 61689:2022作为IEC 61689:2022 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 61689:2022适用于为物理治疗而设计的超声波设备包含超声波换能器产生频率范围为0.5 MHz至5 MHz的连续或准连续（例如音调脉冲）超声波。该文献仅涉及超声理疗设备，该超声理疗设备采用每个治疗头的单个平面非聚焦圆形换能器，产生垂直于治疗头的面的静态波束。本文件规定:-基于参考测试方法的超声理疗设备输出的测量和表征方法；-超声波理疗设备制造商根据参考测试方法规定的特性；-超声波理疗设备产生的超声波场的安全性指南；-基于常规测试方法的超声理疗设备输出的测量和表征方法；-基于常规测试方法的超声理疗设备输出方面的验收标准。超声理疗设备的治疗价值和使用方法不在本文件的范围内。IEC 63009中涉及使用频率范围为20kHz至500kHz的超声波的超声波理疗设备。IEC 61689:2022取消并取代了2013年发布的第三版。本版构成技术修订版。与上一版相比，该版本包括以下重大技术变化。a)水含氧量的要求见6.1。b)6.2中以前的建议已改为要求。c)第3条中的几个定义已根据其他TC 87文件进行了更新。d)以前的信息性附录A已更改为规范性附录，现在包含如何检查是否符合IEC 60601-2-5要求的详细信息。e)附件D已大大缩短，并删除了对现已撤回的监管文件的提及。

IEC 61689:2022 is available as IEC 61689:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

标准预览图