• IEC 61223-3-1:1999

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  31-12-2021

    Language(s):  English, Spanish, Castilian

    Published date:  24-03-1999

    Publisher:  International Electrotechnical Committee

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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 (ATTENUATION
                 devices) and TEST DEVICES
          4.6 Evaluating the test results
    5 Test methods for RADIOGRAPHY EQUIPMENT
          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 indication of the extent of the
                 X-RAY BEAM
          5.6 *Linearity and reproducibility of TRANSMISSION
                 KERMA or RADIATION OUTPUT
          5.7 *ATTENUATION RATIO of material between the
                 PATIENT and the X-RAY IMAGE RECEPTOR
          5.8 *AUTOMATIC EXPOSURE CONTROL (AEC)
          5.9 LINE PAIR RESOLUTION for DIRECT RADIOGRAPHY
          5.10 *AIR KERMA area product indicator
    6 Test methods for RADIOSCOPY EQUIPMENT
          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 Functioning of the AUTOMATIC EXPOSURE RATE
                 CONTROL (AERC)
          6.6 Limitation of the extent of the X-RAY BEAM
          6.7 ATTENUATION RATIO of material between the
                 PATIENT and the X-RAY IMAGE RECEPTOR
          6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the
                 X-RAY IMAGE INTENSIFIER for RADIOSCOPY
          6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with
                 X-RAY IMAGE INTENSIFIER
          6.10 AIR KERMA at the ENTRANCE PLANE of the X-RAY
                 IMAGE INTENSIFIER for CINERADIOGRAPHY or other
                 INDIRECT RADIOGRAPHY systems (excluding digital
                 systems)
          6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other
                 INDIRECT RADIOGRAPHY systems (excluding digital
                 systems)
          6.12 *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY
                 IMAGE INTENSIFIER and for CINERADIOGRAPHY or
                 other INDIRECT RADIOGRAPHY systems (excluding
                 digital systems)
          6.13 *LOW CONTRAST RESOLUTION for RADIOSCOPY with
                 X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY
                 or other INDIRECT RADIOGRAPHY systems (excluding
                 digital systems)
          6.14 AIR KERMA are product indicator
    7 Additional tests required for TOMOGRAPHY EQUIPMENT
          7.1 *Requirements
          7.2 Test method
    8 Test report and statement of compliance
    Annex A (normative) Terminology - Index of defined terms
    Annex B (informative) Test parameters, symbols and units
    Annex C (informative) Examples of low contract TEST DEVICES
    Annex D (informative) Examples of requirements (accuracy,
                          tolerances, discrepancies according to
                          actual IEC standards or state of the
                          art)
    Annex E (informative) Bibliography
    Table B.1 - Test parameters, symbols and units
    Table D.1 - Typical values of FOCAL SPOT dimensions for
                NOMINAL FOCAL SPOT VALUES
    Table D.2 - Values for the discrepancy parameters X, Y and Z
                according to IEC 60601-1-3
    Table D.3 - Typical values for the TRANSMISSION KERMA index
    Table D.4 - Typical values for the ATTENUATION RATIO of
                material between the PATIENT and the X-RAY IMAGE
                RECEPTOR
    Figure 1 - Measuring arrangement for RADIOGRAPHY and
               RADIOSCOPY EQUIPMENT for AIR KERMA measurements
    Figure 2 - Measuring arrangement for RADIOGRAPHY and
               RADIOSCOPY EQUIPMENT to test geometry and
               resolutions
    Figure 3 - LINE PAIR RESOLUTION TEST DEVICE
    Figure 4 - TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE
    Figure 5 - Discrepancies in visual indication of the X-RAY
               FIELD
    Figure 6 - Discrepancies in covering the IMAGE RECEPTION AREA

    Abstract - (Show below) - (Hide below)

    Applies to those components of X-ray equipment which influence the image quality and patient dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems.Defines:- the parameters which describe the performance of X-ray equipment with regard to imaging properties and patient dose;- methods of testing wether measured quantities related to those parameters comply with the specific tolerances.The aim is to verify compliance of the installation with specifications relating to the image quality and patient dose, and to detect malfunctions that are not in agreement with those specifications.

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

    Development Note Also numbered as BS EN 61223-3.1 (05/2005)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Withdrawn

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    I.S. EN 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC 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
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment

    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 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
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    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 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
    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 60580:2000 Medical electrical equipment - Dose area product meters
    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 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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