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  • BS EN 60601-1-3 : 2008

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    MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  British Standards Institution

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

    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 ME EQUIPMENT identification, marking and documents
    6 RADIATION management
    7 RADIATION QUALITY
    8 Limitation of the extent of the X-RAY BEAM and
       relationship between X-RAY FIELD and IMAGE
       RECEPTION AREA
    9 FOCAL SPOT TO SKIN DISTANCE
    10 ATTENUATION of the X-RAY BEAM between the
       PATIENT and the X-RAY IMAGE RECEPTOR
    11 Protection against RESIDUAL RADIATION
    12 Protection against LEAKAGE RADIATION
    13 Protection against STRAY RADIATION
    Annex A (informative) - General guidance and rationale
    Annex B (normative) - Values of the series
            R'10 and R'20, ISO 497
    Annex C (informative) - Mapping between this Edition 2
            of IEC 60601-1-3 and Edition 1
    Bibliography
    Index of defined terms used in this collateral standard
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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    Committee CH/62/2
    Development Note Supersedes 90/55349 DC. (11/2005) Supersedes BS 5724-1.3(1995) & 06/30107360 DC. (09/2008) Supersedes 12/30271192 DC. (07/2013) 2008 version along with its corrigendum remains current. (06/2014) 2008 Edition Re-issued in December 2016 & incorporates AMD 11 2016. 2008 + A1 2013 Edition remains active & will be withdrawn on 01/11/2019. (12/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    BS 7725-3.2(1997) : 1997 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - CHEMICAL METHODS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
    BS EN 61223-3-3 : 1997 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE ON X-RAY EQUIPMENT FOR DIGITAL SUBTRACTION ANGIOGRAPHY (DSA)
    BS 7725-3.3(1997) : 1997 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - CHEMICAL METHODS - IMAGING PERFORMANCE ON X-RAY EQUIPMENT FOR DIGITAL SUBTRACTION ANGIOGRAPHY (DSA)

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

    IEC 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO 7004:2002 Photography Industrial radiographic films Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation
    EN 60522 : 1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    IEC 62220-1:2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    IEC 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    EN 60336:2005 MEDICAL ELECTRICAL EQUIPMENT - X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS - CHARACTERISTICS OF FOCAL SPOTS
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
    ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers
    IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
    IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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