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IEC 60601-2-36

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

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Organization: IEC
Publication Date: 1 April 2014
Status: active
Page Count: 46
ICS Code (Medical equipment in general): 11.040.01
scope:

Replacement:

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;

Document History

IEC 60601-2-36
April 1, 2014
Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
Replacement: 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...
March 1, 1997
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....

References

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