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  • 12/30245174 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2015

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Classification of ME EQUIPMENT and ME
       SYSTEMS
    6 ME EQUIPMENT identification, marking and
       documents
    7 Protection against electrical HAZARDS from
       ME EQUIPMENT
    8 Protection against excessive temperatures and
       other HAZARDS
    9 Accuracy of controls and instruments and protection
       against hazardous outputs
    10 Construction of ME EQUIPMENT
    11 Additional requirements for electromagnetic
       compatibility of ME EQUIPMENT and ME
       SYSTEMS
    Annex A (informative) - General guidance and
            rationale
    Annex B (informative) - Guide to marking and
            labelling requirements for ME EQUIPMENT
            and ME SYSTEMS
    Annex C (informative) - Symbols on marking
    Bibliography
    Index of defined terms used in this collateral standard

    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    Status Superseded
    Superseded By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 60038:2009 IEC standard voltages
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    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 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    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
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    MIL-HDBK-310 Base Document:1997 DEPARTMENT OF DEFENSE HANDBOOK - GLOBAL CLIMATIC DATA FOR DEVELOPING MILITARY PRODUCTS
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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