1.1
Scope
This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101.
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 m onitoring 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 Sta ndards.
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. /
1.1
Domaine d'application
La presente Norme Particuliere s'applique a la securite des APPAREILS POUR LITHOTRITIE CREEE DE FACON EXTRA-CORPORELLE telle qu'elle est definie en 2.1.101.
La possibilite d'appliquer la presente Norme Particuliere est limitee aux elements directement en cause dans le traitement par LITHOTRITIE tels que, sans etre exclusif, le generateur D'IMPULSIONS DE PRESSION, le dispositif supportant le PATIENT, et leurs interactions avec les dispositifs d'imagerie et de surveillance. D'autres 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 l'objet d'autres normes de la CEI.
Quoique la presente Norme Particuliere ait ete concue pour des APPAREILS destines a etre utilises pour la LITHOTRITIE, on l'a concue de maniere que, tant que d'autres normes specifiques ne seront pas disponibles concernant d'autres applications medicales d'appareils therapeutiques a IMPULSIONS DE PRESSION extra-corporelles, la presente Norme pourra etre utilisee comme guide.
| File Size : | 1
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| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 35 |
| Product Code(s) : | 2411975, 2411975 |
| Published : | 03/21/2000 |
