Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields

2Scope / Description

IEC 63045:2020 applies to therapy equipment that generates extracorporeally induced non-focused or weakly focused pressure pulses, as well as to equipment producing extracorporeally induced non-focused or weakly focused mechanical energy where the pressure pulses occur as single events with a duration of up to 25 µs. This document does not apply to therapy equipment that utilizes focusing pressure pulse sources, such as extracorporeal lithotripsy systems, nor to therapy equipment employing other acoustic waveforms, including physiotherapy devices, low-intensity ultrasound systems, and HIFU/HITU equipment. This document specifies measurable parameters used in the declaration of acoustic output for extracorporeal equipment that generates non-focused or weakly focused pressure pulse fields, and it outlines methods for measuring and characterizing such fields. It has been developed for equipment intended for pressure pulse therapy, such as treatments for orthopedic pain—including shoulder pain, tennis elbow, heel spur pain, muscular trigger point therapy, and lower back pain—not for extracorporeal lithotripsy systems (covered in IEC 61846), physiotherapy equipment using alternative waveforms (covered in IEC 61689), or HIFU/HITU equipment (covered in IEC 60601-2-62 and IEC TR 62649).