Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Abstract
This International Standard applies to the basic safety, including the essential performance characteristics, of external pacemakers powered by the device's own power supply. Pacemakers generally treat cardiac arrhythmias. Such arrhythmias reduce cardiac output and can lead to confusion, dizziness, loss of consciousness and death. The aim of pacing is to restore the heart rhythm and cardiac output according to the physiological needs of the patient. There are two different families of pacemakers, implantable pacemakers and external pacemakers. External pacemakers are used for temporary pacing of patients prior to implantation of an implantable pacemaker, but also for temporary pacing during other medical procedures, e.g. cardiac surgery. Pacemakers differ in the way they maintain and monitor cardiac activity in different circumstances.This document applies to patient leads that increase the distance between the non-implantable pulse generator and the stimulating electrode. However, it does not apply to the electrodes. Hazards arising from the intended physiological mode of action of ME devices within the scope of this document are not covered by specific requirements in this document.
Begin
2024-05-28
Planned document number
DIN EN IEC 80601-2-31
Project number
02232298
