IEC 60601-2-4:2002
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators

Standard No.

IEC 60601-2-4:2002

Release Date

2002

Published By

International Electrotechnical Commission (IEC)

Status

Withdraw

Replace By

IEC 60601-2-4:2002/COR1:2004

Latest

IEC 60601-2-4:2010/AMD1:2018

Scope

This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101@ hereinafter referred to as EQUIPMENT.This Particular Standard does not apply to implantable defibrillators@ remote control DEFIBRILLATORS@ external transcutaneous pacemakers@ or separate stand alone CARDIAC MONITORS (which are standardized by IEC 60601-2-27). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape@ delivered energy@ efficacy@ and safety has been specifically excluded from the scope of this standard.However@ due to the critical importance of the therapeutic waveform@ comments have been added to the rationale which address considerations in waveform selection.

IEC 60601-2-4:2002 history

• 2018 IEC 60601-2-4:2010/AMD1:2018 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators; Amendment 1
• 2018 IEC 60601-2-4:2018 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• 2010 IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
• 2005 IEC 60601-2-4:2005 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• 1970 IEC 60601-2-4:2002/COR1:2004 Corrigendum 1 - Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• 2002 IEC 60601-2-4:2002 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• 1983 IEC 60601-2-4:1983 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors