• AAMI IEC 60601-2-4 : 2010 : R2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  10-04-2016

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of IEC 60601-2-4:2010
    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

    Abstract - (Show below) - (Hide below)

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

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

    Committee DF
    Development Note Supersedes AAMI DF80. (01/2011)
    Document Type Standard
    Product Note Reconfirmed 2015
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
    AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
    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
    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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