prEN IEC 61846:2023

This International Standard is applicable to
– therapy equipment using extracorporeally induced focused pressure pulse waves;
– therapy equipment producing focused mechanical energy excluding thermal energy.
This International Standard does not apply to percutaneous and laser lithotripsy equipment.
This international standard does not apply to:
- Histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the pressure pulse
- Non-focused pressure pulse equipment
This International Standard specifies
– measurable parameters which could be used in the declaration of the acoustic output of extracorporeal focused pressure pulse equipment,
– methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment.

NOTE – The parameters defined in this International Standard do not – at the present time – allow quantitative statements to be made about effectiveness and possible hazard. In particular, it is not possible to make a statement about the limits for these effects.
While this particular standard has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal focused pressure pulse equipment, this standard may be used as a guideline.