Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Designation Number:
C22.2 No. 60601-2-36
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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. 
 

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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.