本标准规定: -超声手术单元的基本非热输出特性； -测量这些输出特性的方法； -此类设备制造商应声明的特性。 本标准适用于满足以下a、b和c要求的设备: a） 在20kHz至60kHz的频率范围内操作的超声外科手术系统；和 b） 超声手术系统，其用途是破碎或切割人体组织，无论这些效果是否与组织切除或凝固结合使用；和 c） 超声波手术系统，其中声波通过专门设计的波导管传导，以将能量输送到手术部位。

This standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; - methods of measurement ot these output characteristics; - those characteristics which should be declared by the manufacturers of such equipment. This standard is applicable to equipment which meets the requirements of a, b and c below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.