超声学.包括弹道压力脉冲源在内的非聚焦短压力脉冲源.场特性

[中文适用范围]： 本文件适用于： - 利用体外诱导的非聚焦或弱聚焦压力脉冲进行治疗的设备； - 产生体外诱导的非聚焦或弱聚焦机械能的进行治疗的设备； 其中压力脉冲作为持续时间长达25微秒的单一事件释放。 本文件不适用于： - 使用聚焦压力脉冲源（如体外碎石设备）的治疗设备； - 使用其他声波波形（如物理治疗设备、低强度超声设备和HIFU/HITU设备）的治疗设备。 本文件规定了： - 用于声明产生非聚焦或弱聚焦压力脉冲场的体外设备声学输出的可测量参数； - 测量和表征非聚焦或弱聚焦压力脉冲场的方法。 注1：本文件中定义的参数在发布时——尚不允许就临床疗效和潜在危害进行定量陈述。特别是，不可能就这些效应的限值做出陈述。 注2：图B.1至图B.10以及图2至图4有助于理解本文件中应用的场几何形状。 本文件是为用于压力脉冲治疗的设备开发的，例如骨科疼痛治疗，如肩痛、网球肘痛、足跟骨刺痛、肌筋膜触发点疗法、腰痛等。它不打算用于体外碎石设备（如IEC 61846中所述）、使用其他波形的物理治疗设备（如IEC 61689中所述）和HIFU/HITU设备（见IEC 60601-2-62和IEC TR 62649）。 [外文原描述]： 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).