1 Scope
This International Standard is applicable to
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— lithotripsy equipment using extracorporeally induced pressure waves;
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— lithotripsy equipment producing focused mechanical energy.
This International Standard does not apply to percutaneous and laser lithotripsy equipment.
This International Standard specifies
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— measurable parameters which could be used in the declaration of the acoustic output of extracorporeal lithotripsy equipment,
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— methods of measurement and characterization of the pressure field generated by lithotripsy equipment.
NOTE The parameters defined in this International Standard 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 particular standard 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 pressure pulse equipment, this standard may be used as a guideline.