CAN/CSA-C22.2 NO. 60601.2.36-98(R2012)

This National Standard of Canada is based on the International Standard CEI/IEC 60601-2-36:1997 (First edition, 1997-03). 1. Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. This 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 the 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. 1.2 Object Addition: This Particular Standard specifies requirements for the safety of EQUIPMENT for EXTRACORPOREALLY INDUCED LITHOTRIPSY.