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    I.S. EN 60601-2-4:2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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    Superseded date:  29-10-2019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

    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.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Development Note 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)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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