• CEI EN 60601-2-4 : 2012

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Comitato Elettrotecnico Italiano

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

    FOREWORD
    1 Scope, object and related
        standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 General requirements for
        testing of ME EQUIPMENT
    6 Classification of ME EQUIPMENT
        and ME SYSTEMS
    7 ME EQUIPMENT identification,
        marking and documents
    8 Protection against electrical
        HAZARDS from ME EQUIPMENT
    9 Protection against MECAHNICAL
        HAZARDS of ME EQUIPMENT and
        ME SYSTEMS
    10 Protection against unwanted
        and excessive radiation HAZARDS
    11 Protection against excessive
        temperatures and other HAZARDS
    12 * Accuracy of controls and
        instruments and protection
        against hazardous outputs
    13 HAZARDOUS SITUATIONS and fault
        conditions
    14 PROGRAMMABLE ELECTRICAL MEDICAL
        SYSTEMS (PEMS)
    15 Construction of ME EQUIPMENT
    16 ME SYSTEMS
    17 Electromagnetic compatibility
        of ME EQUIPMENT and ME SYSTEMS
    101 * Charging time
    102 Internal electrical power source
    103 * Endurance
    104 * Synchronizer
    105 * Recovery of the MONITOR and/or
        ECG input after defibrillation
    106 * Disturbance to the MONITOR from
        charging or internal discharging
    107 * Requirements for RHYTHM
        RECOGNITION DETECTOR
    108 DEFIBRILLATOR ELECTRODES
    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

    Abstract - (Show below) - (Hide below)

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

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

    Committee CT 62
    Development Note Classificazione CEI 62-13. To be used in conjunction with CEI EN 60601-1:1998-12. (09/2004) NEW CHILD AMD 1 IS ADDED NOW
    Document Type Standard
    Product Note NEW CHILD AMD 1 IS ADDED NOW
    Publisher Comitato Elettrotecnico Italiano
    Status Current
    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 60601-1-2:2014)
    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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