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EN 60601-2-4:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Superseded date

31-07-2020

Published date

19-08-2011

FOREWORD
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
        EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
        SYSTEMS
201.7 ME EQUIPMENT identification, marking
        and documents
201.8 Protection against electrical HAZARDS from
        ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS
        of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
        radiation HAZARDS
201.11 Protection against excessive temperatures
        and other HAZARDS
201.12 Accuracy of controls and instruments and
        protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
        (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
        and ME SYSTEMS
201.101 Charging time
201.102 INTERNAL ELECTRICAL POWER SOURCE
201.103 Endurance
201.104 SYNCHRONIZER
201.105 Recovery of the MONITOR and/or ECG input
        after defibrillation
201.106 Disturbance to the MONITOR from charging
        or internal discharging
201.107 Requirements for RHYTHM RECOGNITION
        DETECTOR
201.108 DEFIBRILLATOR ELECTRODES
201.109 External pacing (U.S.)
202 Electromagnetic compatibility - Requirements
    and tests
Annexes
Annex C (informative) - Guide to marking and
        labelling requirements for ME EQUIPMENT
        and ME SYSTEMS
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - Mapping between the
         elements of the second edition of
         IEC 60601-2-4 and IEC 60601-2-4:2010
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EC Directives

IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

Committee
CLC/TC 62
DevelopmentNote
Supersedes HD 395.2.4. (03/2003) Supersedes UNE EN 60601-2-4. (02/2014) CHILD IS AVAILABLE NOW
DocumentType
Standard
ProductNote
CHILD IS AVAILABLE NOW
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
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13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
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14/30289772 DC : 0 BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
UNE-EN 16372:2015 Aesthetic surgery services
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
I.S. EN 1789:2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
I.S. EN 62368-1:2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED)
I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
EN 62368-1:2014/AC:2017-03 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED)
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 1789 : 2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
UNE-EN 1789:2007 Medical vehicles and their equipment - Road ambulances
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
EN 16372:2014 Aesthetic surgery services
BS EN 16372:2014 Aesthetic surgery services
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
UNI EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES

AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
AAMI DF39 : 1ED 93 AUTOMATIC EXTERNAL DEFIBRILLATORS AND REMOTE-CONTROL DEFIBRILLATORS

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