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  • 13/30250915 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-12-2014

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests
    6 Results of test and evaluation
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Sequence of testing
    Annex C (normative) - Requirements for the measurement
            equipment and for measurement circuits for
            PROTECTIVE EARTH RESISTANCE and
            leakage currents
    Annex D (informative) - PATIENT ENVIRONMENT
    Annex E (informative) - Allowable values for leakage
            currents from IEC 60601-1
    Annex F (informative) - Testing intervals
    Annex G (informative) - Example of test documentation
    Annex H (informative) - Notes on testing ME SYSTEMS
    Bibliography
    Index of defined terms

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

    Comment Closes On
    Committee CH/62/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 61557-1:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements
    IEC 62020:1998+AMD1:2003 CSV Electrical accessories - Residual current monitors for household and similar uses (RCMs)
    IEC 61010-031:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
    IEC 61557-4:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding
    IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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