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IEC 60601-2-36 Extracorporeally Induced Lithotripsy Testing

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

IEC 60601-2-36 Scope:

IEC 60601 2 36 and EN 60601 2 36 testing 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 medical electronic 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.

EN 60601-2-36 testing 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;

Keystone Compliance assists manufacturers with IEC 60601-2-36 and EN 60601-2-36 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-36 test lab needs.