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:
-
— measurable parameters which could be used in the declaration of the acoustic
output of extracorporeal focused pressure pulse equipment;
-
— 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.