• EN 61223-3-3:1996

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)

    Available format(s): 

    Withdrawn date:  01-08-1997

    Language(s): 

    Published date:  19-12-1996

    Publisher:  European Committee for Standards - Electrical

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

    INTRODUCTION
    1 Scope and object
        1.1 Scope
        1.2 Object
    2 Normative references
    3 Terminology
        3.1 Degree of requirements
        3.2 Use of terms
        3.3 Defined terms
    4 General aspects of acceptance tests
        4.1 General conditions to be considered in test
              procedures
        4.2 Documents and data for the tests
        4.3 Test conditions
        4.4 Test parameters
        4.5 Test equipment including phantoms and test devices
        4.6 Evaluating the test results
    5 Test methods for x-ray equipment for DSA
        5.1 Identification
        5.2 Check of documents
        5.3 Decision on representative DSA operation modes
        5.4 Visual and functional tests
        5.5 Air kerma measurements
        5.6 Dynamic range
        5.7 DSA contrast sensitivity
        5.8 DSA visual spatial resolution
        5.9 Artifacts
        5.10 Compensation for attenuation non-linearity
              (optional)
    6 Test report and statement of compliance
    Annexes
    A Terminology - Index of defined terms
    B Example of a DSA phantom without test step for
        compensation
    C Example of a DSA phantom with test step for compensation
    ZA (normative) Normative references to international
        publications with their corresponding European
        publications

    Abstract - (Show below) - (Hide below)

    Applies to those components of X-ray equipment which influence the image quality of equipment for digital subtraction angiography (DSA) with an imaging system consisting of an X-ray generation subsystem, a detection device comprising an X-ray image intensifier television chain, means of digitization and digital image processing, image storage and image manipulation including subtraction, and facilities for image display. Defines the essential parameters which describe the performance of the above-mentioned components of X-ray equipment with regard to imaging properties, and defines methods of testing whether measured quantities related to those parameters comply with specified tolerances.

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Withdrawn

    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 60417N:1995 Thirteenth supplement
    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
    ISO 2092:1981 Light metals and their alloys Code of designation based on chemical symbols
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    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 61223-2-4:1994 Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras
    IEC 61223-2-5:1994 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices
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