• BS EN 61223-3-4:2000

    Current The latest, up-to-date edition.

    Evaluation and routine testing in medical imaging departments Acceptance tests

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-12-2000

    Publisher:  British Standards Institution

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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 Scope of tests
          4.5 Test equipment including PHANTOMS and TEST
                 DEVICES
          4.6 Evaluating the test results
    5 Test methods for dental X-RAY EQUIPMENT with intra-oral
          X-RAY IMAGE RECEPTOR
          5.1 Visual and functional tests
          5.2 *X-RAY TUBE VOLTAGE
          5.3 *TOTAL FILTRATION
          5.4 *FOCAL SPOT of the X-RAY TUBE
          5.5 Limitation and alignment of the X-RAY BEAM
          5.6 FOCAL SPOT TO SKIN DISTANCE
          5.7 *Reproducibility of RADIATION OUTPUT
          5.8 LINE PAIR RESOLUTION
          5.9 LOW CONTRAST RESOLUTION
    6 Test methods for dental panoramic X-RAY EQUIPMENT with
          extra-oral X-RAY IMAGE RECEPTOR
          6.1 Visual and functional tests
          6.2 X-RAY TUBE VOLTAGE
          6.3 TOTAL FILTRATION
          6.4 FOCAL SPOT of the X-RAY TUBE
          6.5 Limitation and alignment of the X-RAY BEAM
          6.6 FOCAL SPOT TO SKIN DISTANCE
          6.7 Reproducibility of RADIATION OUTPUT
          6.8 LINE PAIR RESOLUTION
          6.9 LOW CONTRAST RESOLUTION
          6.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING
                 SCREENS
          6.11 Image homogeneity
          6.12 Indicators for patients' positioning
          6.13 Panoramic layer
    7 Test methods for dental cephalometric X-RAY EQUIPMENT
          with extra-oral X-RAY IMAGE RECEPTOR
          7.1 Visual and functional tests
          7.2 X-RAY TUBE VOLTAGE
          7.3 TOTAL FILTRATION
          7.4 FOCAL SPOT of the X-RAY TUBE
          7.5 Limitation and alignment of the X-RAY BEAM
          7.6 FOCAL SPOT TO SKIN DISTANCE
          7.7 Reproducibility of RADIATION OUTPUT
          7.8 LINE PAIR RESOLUTION
          7.9 LOW CONTRAST RESOLUTION
          7.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING
                 SCREENS
    8 Test report and statement of compliance
    Annex A (normative) Terminology - Index of defined terms
    Annex B (informative) Examples of requirements (accuracy,
                          tolerances, discrepancies) according
                          to actual IEC standards or state of
                          the art
    Annex C (informative) ACCEPTANCE TEST for processing of
                          non-screen dental X-RAY films (non-
                          screen film)
    Bibliography
    Annex ZA (normative) Normative references to international
                         publications with their corresponding
                         European publications
    Figure 1 - Dental - X-RAY EQUIPMENT with intra-oral X-RAY
               IMAGE RECEPTOR measuring arrangement for AIR KERMA
               and resolution
    Figure 2 - Dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE
               RECEPTOR measuring arrangement for AIR KERMA and
               resolution
    Figure 3 - Dental panoramic X-RAY EQUIPMENT with extra-oral
               X-RAY IMAGE RECEPTOR measuring arrangement for
               AIR KERMA and resolution
    Figure 4 - Example of a dental panoramic X-RAY EQUIPMENT with
               extra-oral digital X-RAY IMAGE RECEPTOR measuring
               arrangement for AIR KERMA, resolution, image
               homogeneity and panoramic layer
    Figure 5 - Example of a cephalometric X-RAY EQUIPMENT with
               extra-oral X-RAY IMAGE RECEPTOR measuring
               arrangement for AIR KERMA and resolution
    Figure 6 - Dental PHANTOM (example)
    Figure 7 - Dental PHANTOM for digital image acquisition or
               processing parts (example)
    Table B.1 - Typical values of FOCAL SPOT dimensions for
                NORMAL FOCAL SPOT VALUES

    Abstract - (Show below) - (Hide below)

    Applicable to components of dental x-ray equipment using radiographic imaging systems, influencing the image quality and patient dose. Applicable to performance of the acceptance test on dental x-ray equipment with intra-oral x-ray image receptor and dental x-ray equipment with extra-oral x-ray image receptor. Is also applicable to dental film and dental image acquisition and processing.

    Scope - (Show below) - (Hide below)

    Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.

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

    Committee CH/62/2
    Development Note Supersedes 99/560236 DC. Also numbered as IEC 61223-3-4. (01/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    DIN 6868-1:1985-02 Image quality assurance in X-ray diagnostics; general
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
    EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
    EN 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    IEC 60601-1:2005+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
    EN 60417-1:2002 GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION
    EN 60417-2:1999 Graphical symbols for use on equipment - Part 2: Symbol originals
    ISO 2092:1981 Light metals and their alloys Code of designation based on chemical symbols
    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 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    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 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
    DIN 6868-51:1993-08 IMAGE QUALITY ASSURANCE IN X-RAY DIAGNOSTICS; ACCEPTANCE TESTING OF DENTAL RADIOGRAPHIC EQUIPMENT; RULES FOR THE INSPECTION OF IMAGE QUALITY AFTER INSTALLATION, MAINTENANCE AND MODIFICATION
    HD 501 : 200S1 MEDICAL RADIOLOGY - TERMINOLOGY
    IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
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