IEC 60601-2-4:2010
Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators

Standard No.

IEC 60601-2-4:2010

Release Date

2010

Published By

International Electrotechnical Commission (IEC)

Status

Be replaced

Replace By

IEC 60601-2-4:2018

Latest

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

Replace

IEC 62D/857/FDIS:2010 IEC 60601-2-4:2002

Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. 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 [2]2). 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 addresses considerations in waveform selection.

IEC 60601-2-4:2010 Referenced Document

• IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEC 61000-4-2 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
• ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

IEC 60601-2-4:2010 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