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I.S. 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

29-10-2019

Language(s)

English

Published date

01-01-2011

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.

DevelopmentNote
Supersedes HD 395.2.4. (03/2003) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
83
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-2-4:2010 Identical
DIN EN 60601-2-4 : 2012 Identical
NF EN 60601-2-4 : 2012 Identical
BS EN 60601-2-4:2011 Identical
SN EN 60601-2-4 : 2003 Identical
UNE-EN 60601-2-4:2004 Identical
EN 60601-2-4:2011 Identical

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
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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