scope:

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.

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.

NOTE 1 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.

NOTE 2 Figure B.1 to Figure B.10 and Figure 2 to Figure 4 are useful to understand the geometry of the field applied in this document.

This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601-2-62 and IEC TR 62649).