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    I.S. EN 62353:2014

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2014

    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
    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 (normative) - 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
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications

    Abstract - (Show below) - (Hide below)

    Pertains to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.

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

    Development Note 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 Current

    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 61557-16:2014 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 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
    EN 61010-031:2015 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
    EN 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
    EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    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
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    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
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