EN 60601-2-4

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Logo of the German Institute for Standardization DIN EN 60601-2-4
Area Medical technology
title Medical electrical equipment - Part 2-4: Particular requirements for the safety of defibrillators
Latest edition 2003-07
ISO IEC 60601-2-4: 2002

The EN 60601-2-4 entitled "Electrical Medical devices - Part 2-4: Particular requirements for the safety of defibrillators" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-4 .

The standard is based on the international version IEC 60601-2-4. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-4 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for defibrillators .

validity

The German edition 7.2002 is accepted as a German standard from the date of its publication.

  • The current version (7.2002) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • Corrigendum 1 appeared in August 2004 (incorrect electrical units corrected) and Corrigendum 2 appeared in November 2005 (subsection 57.10 bb) was replaced).
  • In May 2007 a draft for the 3rd edition of DIN EN 60601-1 was published.

scope of application

These special stipulations define safety requirements for defibrillators, hereinafter referred to as device. They do not apply to implantable defibrillators, remotely controlled defibrillators, external transcutaneous pacemakers or separate stand-alone monitors (which are standardized by EN 60601-2-27 ). Monitors that use separate EKG monitoring electrodes are outside the scope of this standard unless they are used as the sole basis for AED rhythm detection or beat detection for synchronized cardioversion .

The choice of a particular curve shape including "waveshape", supplied energy, effectiveness and safety was expressly excluded from the scope of this standard. However, because of the critical importance of the therapeutic waveform, comments have been added to the discussion to address waveform selection considerations.

extra information

The following changed requirements are contained in EN 60601-2-4 (extract):

  • separation
  • Leakage currents
  • Dielectric strength
  • Electromagnetic compatibility
  • safety
  • defibrillator-specific requirements