Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
Abstract
This International Standard is applicable to the basic safety and essential performance of equipment for extracorporeally induced lithotripsy, as described in 201.3.206, including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses, hereinafter referred to as ME equipment. The applicability of these special provisions is limited to components that are directly necessary for lithotripsy treatment, such as, for example, but not exclusively, the pressure pulse generator, the patient support system and their interactions with imaging and monitoring systems. Other equipment, such as PCs for planning treatment, X-ray and ultrasound equipment are excluded from this standard because they are covered by other applicable IEC standards.
Begin
2025-03-13
Planned document number
DIN EN IEC 60601-2-36
Project number
02232968
