BS EN 60601-2-36:1997 Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
Addition:
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 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.
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.
BS EN 60601-2-36:1997 history
2015BS EN 60601-2-36:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
1997BS EN 60601-2-36:1997 Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy