IEC 60601-2-36-ed.2.0

Annotation of standard text IEC 60601-2-36-ed.2.0 :

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012. LIEC 60601-2-36:2014 sapplique a la securite de base et aux performances essentielles des appareils pour lithotritie creee de facon extracorporelle, y compris des appareils pour dautres applications medicales des impulsions de pression focalisees therapeutiques creees de facon extracorporelle. La possibilite dappliquer la presente norme particuliere est limitee aux elements directement en cause dans le traitement par lithotritie tels que, sans etre exclusif, le generateur dimpulsions de pression, le dispositif supportant le patient, et leurs interactions avec les dispositifs dimagerie et de surveillance. Dautres dispositifs, tels que les calculateurs organisant le traitement du patient, les dispositifs a rayonnement X et a ultrasons, sont exclus de la presente norme, car ils font lobjet dautres normes IEC applicables. La presente norme particuliere ne sapplique pas aux appareils a ultrasons prevus pour etre utilises en physiotherapie; et aux appareils a ultrasons prevus pour etre utilises en therapie HITU (ultrasonore therapeutique de haute intensite) et autres appareils de therapie decrits a lAnnexe AA. Cette deuxieme edition annule et remplace la premiere edition de lIEC 60601-2-36 parue en 1997. Cette edition constitue une revision technique et saligne structurellement avec lIEC 60601-1:2005 et son Amendement 1:2012.