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    I.S. EN 61223-3-2:2008

    Current The latest, up-to-date edition.

    EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2008

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General aspects of the ACCEPTANCE TEST
      4.1 Levels of compliance
      4.2 General conditions in test procedures
      4.3 Documents and data for the tests
      4.4 Test conditions
      4.5 Scope of tests
      4.6 Test EQUIPMENT
      4.7 Evaluating the test results
    5 Test methods for mammographic X-RAY EQUIPMENT
      5.1 Initial test and inventory
      5.2 X-RAY TUBE VOLTAGE
      5.3 HALF VALUE LAYER (HVL)
      5.4 NOMINAL FOCAL SPOT VALUE
      5.5 X-RAY FIELD limitation and beam alignment
      5.6 Radiation output
      5.7 AUTOMATIC EXPOSURE CONTROL (AEC)
      5.8 Reproducibility of the AIR KERMA
      5.9 ATTENUATION RATIO of material between the upper surface of
           the PATIENT SUPPORT and the IMAGE RECEPTION PLANE
      5.10 Breast COMPRESSION DEVICE
      5.11 Uniformity
      5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital
           X-ray image receptors, including storage phosphor systems
      5.13 Spatial resolution
      5.14 LOW CONTRAST DETECTABILITY
      5.15 Entrance surface AIR KERMA
      5.16 Biopsy needle positioning accuracy of MAMMOGRAPHIC
           STEREOTACTIC DEVICES
    6 Baseline values for CONSTANCY TESTS
    7 Test report and statement of compliance
    Annex A (informative) TEST DEVICES and arrangements for testing
            the automatic exposure control system with a digital X-RAY
            IMAGE RECEPTOR
    Annex B (informative) TEST DEVICE for testing the dynamic range
            of systems with a digital X-RAY IMAGE RECEPTOR
    Annex C (informative) Test methods for screen-film X-ray image
            receptor
    Annex D (informative) Test methods for storage phosphor system
    Annex E (informative) Example of a method for the determination
            of the AVERAGE GLANDULAR DOSE
    Annex F (informative) Example of TEST DEVICES and arrangements
            for testing the system contrast transfer function for
            systems with a digital X-RAY IMAGE RECEPTOR
    Annex G (informative) LOW CONTRAST DETECTABILITY test for
            mammographic X-RAY EQUIPMENT using an integrated digital
            X-RAY IMAGE RECEPTOR or storage phosphor plates
    Annex H (informative) Example of a mammographic stereotactic
            TEST DEVICE
    Annex I (normative) Set-up for HALF-VALUE LAYER measurements
    Annex J (informative) Definition of the ROIs for testing lag
            effects
    Annex K (informative) ARTIFACTS and other non-uniformities
    Annex L (informative) Cross reference and history
    Annex ZA (normative) Normative references to international
             publications with their corresponding European
             publications
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to the effectiveness of mammographic X-RAY EQUIPMENT, with respect to image quality and dose, in combination with aspects of EQUIPMENT safety.

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

    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 3386-1:1986 Polymeric materials, cellular flexible — Determination of stress-strain characteristics in compression — Part 1: Low-density materials
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    EN 60601-2-45:2011/A1:2015 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 60601-2-45:2011/A1:2015)
    IEC 61674:2012 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 845:2006 Cellular plastics and rubbers — Determination of apparent density
    EN 61676:2002/A1:2009 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS USED FOR NON-INVASIVE MEASUREMENT OF X-RAY TUBE VOLTAGE IN DIAGNOSTIC RADIOLOGY
    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 TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO 4090:2001 Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications
    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
    EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    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 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
    IEC 61223-3-3:1996 Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA)
    IEC 61223-3-4:2000 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
    IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
    IEC 61676:2002+AMD1:2008 CSV Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
    IEC 61223-2-4:1994 Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras
    EN 573-3:2013 Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products
    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 61223-2-5:1994 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices
    EN 61674:2013 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    View more information

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