IEC 63045:2020 PRV
Pre release version
Ultrasonics - Non-focusing short pressure pulse sources including pneumatic and ballistic pressure pulse sources - Characteristics of fields
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 and to 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 non-focusing or weakly focusing pressure pulse sources,
– methods of measurement and characterization of the pressure field generated by non-focusing or weakly focusing pressure pulse equipment.
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).
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