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  • IEC 61223-2-6:2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment

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

    Superseded date:  31-12-2021

    Language(s):  English - French, Spanish, Castilian

    Published date:  28-11-2006

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
    2 Normative references
    3 Terms and definitions
    4 General aspects of CONSTANCY TESTS
      4.1 Preconditions
      4.2 General conditions affecting test procedures
      4.3 Establishment of BASELINE VALUES
      4.4 Identification of equipment, instrumentation and
          test conditions
      4.5 Scope of the CONSTANCY TESTS
      4.6 Test equipment, including PHANTOMS and TEST DEVICES
      4.7 Frequency of CONSTANCY TESTS
    5 Test methods for CT SCANNERS
      5.1 Positioning of the PATIENT SUPPORT
      5.2 PATIENT positioning accuracy
      5.3 TOMOGRAPHIC SECTION THICKNESS
      5.4 Dose
      5.5 NOISE, UNIFORMITY AND MEAN CT NUMBERS
      5.6 SPATIAL RESOLUTION
    Annex A (informative) Guidance on action to be taken
    Annex B (informative) Alternate test methods for SPATIAL
            RESOLUTION
    Annex C (informative) TOMOGRAPHIC SECTION THICKNESS for
            helical scanning
    Annex D (informative) Visual method for LOW CONTRAST
            RESOLUTION
    Bibliography
    Index of terms

    Abstract - (Show below) - (Hide below)

    This part of IEC 61223 provides assistance in performing constancy tests on a CT scanner. It applies to those components of CT scanners which influence the image quality, patient dose and positioning. This standard
    - defines the essential parameters which describe the performance of CT scanners with regard to image quality, patient dose and positioning; the list of parameters to be tested can be found in section 4.5;
    - defines the methods of testing the essential parameters;
    - provides criteria to be applied in the evaluation of data for compliance with the tolerances of the parameters specified by the accompanying documents and with respect to baseline values. These methods rely on non-invasive measurements, using appropriate test equipment, performed to ensure that the functional performance of equipment meets established criteria or to enable the early recognition of changes in the properties of components of the equipment. The aim is to verify compliance with specifications affecting the image quality, patient dose and patient positioning.

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

    Development Note Stability Date: 2018. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Supersedes

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

    CEI EN 62464-1 : 2007 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS
    ISO 19233-1:2017 Implants for surgery — Orthopaedic joint prosthesis — Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment
    03/304751 DC : DRAFT APR 2003 IEC 61223-3-5 ED.1.0 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN 62464-1:2007 Magnetic resonance equipment for medical imaging Determination of essential image quality parameters
    IEC TR 61948-3:2018 Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    04/30124942 DC : DRAFT NOV 2004 BS EN 61223-2-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    16/30300186 DC : 0 BS ISO 19233-1 - IMPLANTS FOR SURGERY - ORTHOPAEDIC JOINT PROSTHESIS - PART 1: PROCEDURE FOR PRODUCING PARAMETRIC 3D BONE MODELS FROM CT DATA OF THE KNEE
    BS ISO 19233-1:2017 Implants for surgery. Orthopaedic joint prosthesis Procedure for producing parametric 3D bone models from CT data of the knee
    I.S. EN 61223-3-5:2004 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    IEC 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
    I.S. EN 62464-1:2007 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS
    EN 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
    EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment

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

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    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
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
    ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
    ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
    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 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    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 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
    ASTM E 1695 : 1995 Standard Test Method for Measurement of Computed Tomography (CT) System Performance
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    IEC 61223-2-4:1994 Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras
    IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
    IEC 61223-2-5:1994 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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