1 Scope
This document is applicable to:
This document does not apply to percutaneous and laser lithotripsy equipment.
This document does not apply to:
This document specifies:
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— measurable parameters which could be used in the declaration of the acoustic output
of extracorporeal focused pressure pulse equipment;
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— methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment.
NOTE The parameters defined in this document 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 document 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 document can be used as a guideline.