IEC 61846:2025 is relevant for the following applications:

Therapy devices that utilize extracorporeal focused pressure pulse waves.
Therapy devices that generate focused mechanical energy, excluding any thermal energy.

This standard does not cover percutaneous and laser lithotripsy devices. Additionally, it does not apply to:

Histotripsy or other therapeutic ultrasound bursts that last longer than the pressure pulse duration.
Equipment that produces non-focused pressure pulses.

IEC 61846:2025 outlines:

Quantifiable parameters that may be used to declare the acoustic output of extracorporeal focused pressure pulse devices.
Measurement and characterization techniques for the pressure field created by focused pressure pulse equipment.

Although this standard has been specifically developed for devices used in lithotripsy, it is structured to serve as a guideline for other medical applications of therapeutic extracorporeal focused pressure pulse devices in the absence of more specific standards.

IEC 61846:2025 supersedes the first edition released in 1998 and includes various technical revisions.