Standard

NEN-EN-IEC 60601-2-36:2015 en

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

145,59 158,69 Incl BTW

About norm

Status Current
Number of pages 41
Committee Medische elektrische toestellen
Published on 01-06-2015
Language English
NEN-EN-IEC 60601-2-36 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;

Details

ICS-code 11.040.01
Dutch title Medische elektrische toestellen - Deel 2-36: Bijzondere eisen voor de veiligheid van toestellen voor vanaf buiten het lichaam opgewekte blaassteenvergruizing
English title Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
Replaces

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