ČSN EN IEC 63045

This document 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 s. This document does not apply to - therapy equipment using focusing pressure pulse sources such as 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 equipment producing a non-focused or weakly focused pressure pulse field, - methods of measurement and characterization of non-focused or weakly focused pressure pulse fields.