CSA C22.2 NO. 60601-2-36:16 (R2020)

This is the second edition of CAN/CSA-C22.2 No. 60601-2-36, Medical electrical equipment — Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-36 (second edition, 2014-04). It supersedes the previous edition, published in 1998 as CAN/CSA-C22.2 No. 60601.2.36 (adopted IEC 60601-2-36:1997). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 60601-2-36” throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).

201.1.1 Scope:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES, hereafter referred to as ME EQUIPMENT. 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.

This particular standard does not apply to:

• ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy;
• ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;

201.1.2 Object:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeal focused PRESSURE PULSES