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 µs.
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.
