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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 3-169
IEC  60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Identical Adoption
ANSI AAMI IEC 60601-2-4:2010/A1:2018 (Consolidated Text)
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27:2011 [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. DEFIBRILLATOR electrodes as described in 201.108 can also be used for ECG monitoring; however, due to the larger electrode area, the requirements of IEC 60601-2-27 are not applicable for DEFIBRILLATOR ELECTRODES.

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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
-Subclause 201.107 - Requirements for Rhythm Recognition Detector

-Clause 202 - Electromagnetic compatibility - Requirements and tests
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:

-Subclause 201.107 - Requirements for Rhythm Recognition Detector is not consistent with published literature, see reference #1 listed below.

-Clause 202 - Electromagnetic compatibility - Requirements and tests is not consistent with another recognized standard, see IEC 60601-1-2 listed below. While clause 202 was updated to refer to IEC 60601-1-2:2014 (4th Edition), relevant text within clause 202 was not updated to align with the 4th Edition.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.5300 Dc-Defibrillator, Low-Energy, (Including Paddles) Class 2 LDD
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
N/A Wearable Automated External Defibrillator Class 3 MVK
Relevant FDA Guidance and/or Supportive Publications*
1. Kerber RE., et al. Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. Circulation. 1997;95:1677-1682.

2. IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

3. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Loriano Galeotti
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.