Standards Development

Scope

This document is applicable to

– therapy equipment using intraluminal or invasively induced ultrasonic short pressure pulses through use of a catheter

This document does not apply to

– therapy equipment using extracorporeally or non-invasively induced acoustic pulses

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

– therapy equipment by which the primary mechanism of action is ablation of the lesion due to cavitation bubble collapse.

– therapy equipment which do not have an acoustic based mechanism of action (including therapy equipment that utilize mechanical pressure, e.g. iterations of angioplasty technology)

This document specifies

– measurable parameters which are used in the declaration of the acoustic output of intraluminal ultrasonic short pressure pulse equipment

– methods of measurement and characterization of intraluminal ultrasonic short pressure pulse acoustic fields.

NOTE The parameters defined in this document do not - at the time of publication - 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 document has been developed for equipment intended for use in intraluminal ultrasonic short pressure pulse therapy, for example intravascular lithotripsy therapy of calcified lesions found in peripheral artery disease, coronary artery disease, valvular calcium, and other calcified diseases in the body. It is not intended to be used for extracorporeal lithotripsy equipment and therapeutic focused short pressure pulse sources (as described in IEC 61846:2025), physiotherapy equipment using other waveforms (as described in IEC 61689:2022 [15]), non-focusing short pressure pulse sources including ballistic pressure pulse sources (as described in IEC 63045:2020 [16]), and HIFU/HITU equipment (see IEC 60601-2-62 [17] and IEC TR 62649 [18]).

Equipment which do not produce an ultrasonic acoustic field are not covered within the scope of this document.