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    I.S. EN 61223-2-6:2007

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  21-10-2022

    Language(s):  English

    Published date:  01-01-2007

    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 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
    Annex ZA (normative) Normative references to international
             publications with their corresponding European
             publications

    Abstract - (Show below) - (Hide below)

    Describes the essential parameters which describe the performance of CT SCANNERS with regard to image quality, PATIENT dose and positioning; 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.

    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 Withdrawn
    Supersedes

    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 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
    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 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
    EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
    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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