IEC 63045:2020适用于 -使用体外诱导的非聚焦或弱聚焦压力脉冲的治疗设备； -产生体外诱导的非聚焦或弱聚焦机械能的治疗设备， 其中压力脉冲作为持续时间高达25 μ s的单个事件被释放。 本文件不适用于 -使用聚焦压力脉冲源的治疗设备，例如体外碎石设备； -使用其他声波的治疗设备，如物理治疗设备、低强度超声设备和HIFU/HITU设备。 本文件规定 -可测量参数，其用于声明产生非聚焦或弱聚焦压力脉冲场的体外设备的声学输出， -非-的测量和表征方法聚焦或弱聚焦压力脉冲场。 本文件是为用于压力脉冲治疗的设备开发的，例如治疗骨科疼痛，如肩痛、网球肘痛、足跟骨刺痛、肌肉触发点治疗、下背部疼痛等。不适用于体外碎石设备（如IEC 61846中所述）、使用其他波形的理疗设备（如IEC 61689中所述）和HIFU/HITU设备（参见IEC 60601 2-62和IEC TR 62649）。

IEC 63045:2020 is applicable to
– therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses;
– therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy,
where the pressure pulses are released as single events of duration up to 25 μs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment;
– therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field,
– methods of measurement and characterization of non-focused or weakly focused pressure pulse fields.
This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).