YY/T 0644-2008 in English

本标准等同采用IEC 61847：1998《超声外科手术系统基本输出特性的测量和公布》。
本标准将原文中的“本国际标准”改为“本标准”，并做了极少量的编辑性修改，不影响一致性程度。
本标准规定了超声外科手术系统的主要非热输出特性、输出特性的测量方法、设备制造商应公布的特性参数。
本标准不适用于由体外引用压力脉冲，经由液体媒质和人体软组织进行聚焦的碎石设备；作为冶疗过程某一部分的外科装置（温热疗系统）；
——声学应用部位不在纵向振动治疗头尖端且因此不符合本标准使用的单级模型的外科装置。

Scope

This standard specifies:
　——The main non-thermal output characteristics of ultrasonic surgical systems;
　——Measurement methods of output characteristics;
　——Characteristic parameters that should be published by equipment manufacturers. The equipment applicable to this standard must meet the following requirements a), b) and c) at the same time: a) Work in the frequency range of 20kHz to 60kHz; b) Used to crush or cut human tissue (regardless of whether these functions are related to tissue related to removal or coagulation); c) Sound waves deliver energy to the surgical site through specially designed waveguides. This standard does not apply to:
　——lithotripsy equipment that introduces pressure pulses from outside the body and focuses them through liquid coal and human soft tissue;
　——surgical devices (hyperthermia systems) that are part of the treatment process;
　——the acoustic application site does not vibrate longitudinally A surgical device that is at the tip of the treatment head and therefore does not comply with the single-stage model used in this standard.