UNE-EN IEC 63045:2020

This International Standard 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 microseconds.

This International Standard does not apply

to therapy equipment using focused pressure pulse sources and to extracorporeal lithotripsy equipment.

to therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU / HITU equipment.

This International Standard specifies

measurable parameters which should be used in the declaration of the acoustic output of extracorporeal non-focused or weakly focused pressure pulse sources,

methods of measurement and characterization of the pressure field generated by non-focused or weakly focused pressure pulse equipment.

NOTE 1: The parameters defined in this International Standard do not at the present time allow quantitative statements to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the limits for these effects.

This particular standard has been developed for equipment intended for use in pressure pulse therapy, e.g. 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).