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  • IEC 61223-3-5:2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance 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    Superseded date:  31-12-2021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): 

    Published date:  23-08-2004

    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 ACCEPTANCE TESTS
      4.1 General conditions to be considered in test
          procedures
      4.2 Documents and data for the tests
      4.3 Identification of EQUIPMENT, instrumentation and
          test conditions
      4.4 Scope of tests
      4.5 Test EQUIPMENT, including PHANTOMS and TEST DEVICES
    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, MEAN CT NUMBER and UNIFORMITY
      5.6 SPATIAL RESOLUTION
    Annex A (normative) Terminology - Index of defined terms
    Annex B (informative) Recommended criteria for test results
    Annex C (informative) Visual Method for LOW CONTRAST
                          RESOLUTION
    Annex D (informative) Accuracy of the gantry tilt
    Annex E (informative) DOSE PROFILE
    Annex F (informative) Alternate test methods for SPATIAL
                          RESOLUTION
    Annex G (informative) TOMOGRAPHIC SECTION THICKNESS for helical
                          scanning
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard- defines the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning; - defines the methods of testing the essential parameters;- evaluates compliance with the tolerances of the parameters specified by the accompanying documents.These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during the installation or after it has been completed. Signed statements covering steps in the installation procedure may be used as part of the acceptance test report.This part of IEC 61223 is intended to assist in performing the acceptance tests on a CT scanner. The aim is to verify compliance of the installation with specifications affecting the image quality, patient dose and positioning.The contents of the corrigendum of March 2006 have been included in this copy.

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

    Committee TC 62/SC 62B
    Development Note Stability Date: 2018. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

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

    IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    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
    I.S. EN 61223-2-6:2007 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    BS EN 60601-2-44 : 2009 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)
    07/30136476 DC : DRAFT APR 2007 IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    UNE-EN 60601-2-44:2010 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
    I.S. EN 60601-2-44:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    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 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
    BS EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments Constancy 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
    07/30166162 DC : 0 BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    NF EN 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy 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
    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 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
    IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
    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 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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