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  • IEC TR 60601-4-2:2016

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  13-05-2016

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
    2 Normative references
    3 Terms and definitions
    4 General recommendations
    5 ME EQUIPMENT and ME SYSTEMS identification,
      marking and documents
    6 Documentation of the tests
    7 EMISSIONS
    8 IMMUNITY recommendations
    9 Test report
    Annex A (informative) - General guidance and
            rationale
    Annex B (informative) - Guide to labelling
            recommendations
    Annex C (informative) - Determination of
            IMMUNITY TEST LEVELS for SPECIAL
            ENVIRONMENTS
    Annex D (informative) - Identification of
            specific IMMUNITY performance criteria
    Annex E (informative) - Performance criteria
            specified by IEC 61000-6-x generic EMC
            standards
    Annex F (informative) - Mapping between this
            document and the elements of IEC 60601-1-2:2014
    Bibliography
    Index of defined terms used in this technical report

    Abstract - (Show below) - (Hide below)

    IEC TR 60601-4-2:2016(E) applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances.

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

    Development Note Stability date: 2019. (05/2016)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    IEEE/ANSI C63.15-2010 RECOMMENDED PRACTICE FOR THE IMMUNITY MEASUREMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT
    AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS

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

    IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    ISO 16750-2:2012 Road vehicles Environmental conditions and testing for electrical and electronic equipment Part 2: Electrical loads
    IEC 60601-2-3:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 61000-6-2:2016 Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
    IEC TS 61000-1-2:2008 Electromagnetic compatibility (EMC) - Part 1-2: General - Methodology for the achievement of functional safety of electrical and electronic systems including equipment with regard to electromagnetic phenomena
    IEC TR 61000-4-1:2016 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    ISO 7637-2:2011 Road vehicles Electrical disturbances from conduction and coupling Part 2: Electrical transient conduction along supply lines only
    IEC 61000-6-1 : 3.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-1: GENERIC STANDARDS - IMMUNITY STANDARD FOR RESIDENTIAL, COMMERCIAL AND LIGHT-INDUSTRIAL ENVIRONMENTS
    IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC TR 61000-2-5:2017 Electromagnetic compatibility (EMC) - Part 2-5: Environment - Description and classification of electromagnetic environments
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    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 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEC 61000-6-1:2016 Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments
    IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    ISO 7137:1995 Aircraft Environmental conditions and test procedures for airborne equipment
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    IEC 61000-6-2 : 3.0:2016 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS
    CISPR 24:2010+AMD1:2015 CSV Information technology equipment - Immunity characteristics - Limitsand methods of measurement
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