• BS 5724-2-45(2001) : 2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES

    Available format(s): 

    Superseded date:  31-05-2011

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    SECTION 1: GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    5 Classification
    6 Identification, marking and documents
        6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
        6.7 Indicator lights and push-buttons
        6.8 ACCOMPANYING DOCUMENTS
    SECTION 2: ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    15 Limitation of voltage and/or energy
    16 ENCLOSURES and PROTECTIVE COVERS
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
        19.3 Allowable values
    20 Dielectric strength
        20.3 Values of test voltages
        20.4 Tests
    SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    22 Moving parts
    24 Stability in normal use
    SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
    EXCESSIVE RADIATION
    29 X-RADIATION
        29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT
    36 Electromagnetic compatibility
    SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
               FLAMMABLE ANAESTHETIC MIXTURES
    SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
               OTHER SAFETY HAZARDS
    42 Excessive temperatures
    SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
               HAZARDOUS OUTPUT
    50 Accuracy of operating data
        50.1 General
        50.101 Indication of electric and RADIATION output
        50.102 Reproducibility, linearity and constancy
        50.103 Accuracy of LOADING FACTORS
        50.104 Test conditions
        50.105 Conditions for measuring AIR KERMA
    51 Protection against hazardous output
    SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
    SECTION 10: CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
        56.7 Batteries
    57 MAINS PARTS, components and layout
        57.10 CREEPAGE DISTANCES and AIR CLEARANCES
    Annex AA (normative) Terminology - Index of defined terms
    Annex BB (informative) Rationale for allowing full IRRADIATION
             of mammograms
    Annex CC (normative) Values of the series R'10 and R'20, ISO 497
    Bibliography

    Abstract - (Show below) - (Hide below)

    Includes safety requirements for X-ray equipment designed for mammography, together with mammographic stereotactic devices.

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

    Committee CH/71
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
    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 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
    IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
    ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
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