Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
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 the standard, because they are treated in other applicable IEC standards.
Required fields are indicated with *
