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  • 09/30170496 DC : 0

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    BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-05-2011

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terminology and definitions
    201.4 General requirements
    201.5 General requirements for testing of
           ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and
           ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking
           and documents
    201.8 Protection against electrical HAZARDS from
           ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of
           ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
           X-RADIATION HAZARDS
    201.11 Protection against excessive temperatures and
           other HAZARDS
    201.12 Accuracy of controls and instruments and
           protection against hazardous outputs
    201.13 Hazardous situations and fault conditions
    201.14 Programmable electrical medical systems (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT
           and ME SYSTEMS
    202 Medical electrical equipment - Part 1-2: General
        requirements for safety - Collateral standard:
        Electromagnetic compatibility - Requirements and tests
        202.101 Immunity testing of ESSENTIAL PERFORMANCE
    203 Medical electrical equipment - Part 1-3: General
        requirements for basic safety and essential performance -
        Collateral Standard: Radiation protection in diagnostic
        X-ray equipment
        203.4 General requirements
        203.5 ME EQUIPMENT identification, marking and documents
        203.6 X-RADIATION management
        203.7 RADIATION QUALITY
        203.8 Limitation and indication of the extent of the X-RAY
               BEAM and relationship between X-RAY FIELD and
               IMAGE RECEPTION AREA
        203.10 Attenuation of the X-RAY BEAM between the
               PATIENT and the X-RAY IMAGE RECEPTOR
        203.11 Protection against RESIDUAL RADIATION
        203.13 Protection against STRAY RADIATION
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard

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

    Comment Closes On
    Committee CH/62/2
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    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
    ISO 9236-3:1999 Photography Sensitometry of screen/film systems for medical radiography Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography
    IEC 62220-1-2:2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
    ISO 12052:2017 Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management
    IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
    ISO 4090:2001 Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications
    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
    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 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    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
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    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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