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EN 60601-2-36:1997 Standard

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  Keywords:

#iec #ultrasound #devices #standard #edition

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsyIEC 60601-2-36:1997

  Purpose

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. 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; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

  Publication

Friday 17th of November 2017

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