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  • IEC 62220-1:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency

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

    Superseded date:  12-03-2015

    Language(s):  English, Spanish, Castilian

    Published date:  23-10-2003

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terminology and definitions
    4 Requirements
      4.1 Operating conditions
      4.2 X-RAY EQUIPMENT
      4.3 RADIATION QUALITY
      4.4 TEST DEVICE
      4.5 Geometry
      4.6 IRRADIATION conditions
          4.6.1 General conditions
          4.6.2 Exposure measurement
          4.6.3 Avoidance of LAG EFFECTS
          4.6.4 IRRADIATION to obtain the CONVERSION FUNCTION
          4.6.5 IRRADIATION for determination of the NOISE POWER
                SPECTRUM
          4.6.6 IRRADIATION with TEST DEVICE in the RADIATION BEAM
    5 Corrections of RAW DATA
    6 Determination of the DETECTIVE QUANTUM EFFICIENCY
      6.1 Definition and formula of DQE(u,v)
      6.2 Parameters to be used for evaluation
      6.3 Determination of different parameters from the images
          6.3.1 Linearization of data
          6.3.2 The NOISE POWER SPECTRUM (NPS)
          6.3.3 Determination of the MODULATION TRANSFER FUNCTION
                (MTF)
    7 Format of conformance statement
    8 Accuracy
    Annex A (normative) Determination of LAG EFFECTS
      A.1 Test of additive LAG EFFECTS
      A.2 Test of multiplicative LAG EFFECTS
    Annex B (normative) Terminology - Index of defined terms
    Annex C (informative) Calculation of the input NOISE POWER
                          SPECTRUM
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the method for the determination of the detective quantum efficiency (DQE) of digital X-ray imaging devices as a function of exposure and of spatial frequency for the working conditions in the range of the medical application as specified by the manufacturer.Is applicable to projection digital X-ray imaging devices producing images in digital format that are used for medical diagnosis. It is restricted to digital X-ray imaging devices that are used for radiographic imaging, such as CR systems, selenium-based systems, flat panel detectors, optically coupled CCD detectors, and digital X-ray image intensifiers used for single exposures.

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

    Development Note Stability Date: 2014. (10/2012)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

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

    BS EN 62220-1-3:2008 Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency. Detectors used in dynamic imaging
    BS EN 62220-1-2:2007 Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency. Detectors used in mammography
    06/30107360 DC : 0 IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    CEI EN 62220-1-2 : 2009 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY
    NF EN 60601-2-54 : 2009 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    CSA C22.2 No. 60601.2.43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    NF EN 60601-2-43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    EN 60601-2-65:2013 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    EN 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
    NBR IEC 60601-2-43 : 2012 ERRATA 1 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    VDI/VDE 2617 Blatt 6.1:2007-05 Accuracy of coordinate measuring machines - Characteristics and their testing - Coordinate measuring machines with optical probing - Code of practice for the application of DIN EN ISO 10360 to coordinate measuring machines with optical sensors for lateral structures
    07/30161724 DC : 0 BS IEC 62220-1-3 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-3: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING
    BS EN 60601-2-65:2013 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    BS EN 60601-2-43:2010 Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    I.S. EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    I.S. EN 60601-2-65:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV))
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    I.S. EN 62494-1:2008 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
    I.S. EN 60601-1-3:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
    NEMA XR 27:2013 X-ray Equipment for Interventional Procedures User Quality Control Mode
    NEMA/MITA XR 30:2016 Quality Control Tools for Digital Projection Radiography
    DIN 6868-161:2013-01 Image quality assurance in diagnostic X-ray departments - Part 161: RoeV acceptance testing of dental radiographic equipment for digital cone-beam computed tomography
    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
    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
    12/30246621 DC : 0 BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR 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
    NF EN 60601-2-65 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    ASTM E 2597/E2597M : 2014 : REDLINE Standard Practice for Manufacturing Characterization of Digital Detector Arrays
    I.S. EN 62220-1-3:2008 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-3: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING
    EN 60601-2-43:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
    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
    ASTM E 2597 : 2007 Standard Practice for Manufacturing Characterization of Digital Detector Arrays
    ASTM E 2597 : 2007 : EDT 1 Standard Practice for Manufacturing Characterization of Digital Detector Arrays
    UNE-EN 60601-2-54:2010 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    CEI EN 62220-1-3 : 2010 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN DYNAMIC IMAGING
    07/30156446 DC : 0 BS IEC 62494-1 - MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
    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
    I.S. EN 60601-2-43:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    I.S. EN 62220-1-2:2007 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    IEC 60601-2-65:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    IEC 62220-1-3:2008 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
    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 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
    IEC 62220-1-2:2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
    BS EN 60601-1-3 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)
    I.S. EN 60601-2-65:2013/A1:2020 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017)
    EN 62220-1-2 : 2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
    BS EN 62494-1:2008 Medical electrical equipment. Exposure index of digital X-ray imaging systems Definitions and requirements for general radiography
    CEI EN 62494-1 : 2010 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
    CEI EN 60601-2-65 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    CAN/CSA-C22.2 No. 60601-2-65 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    EN 62220-1-3:2008 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
    EN 60601-2-54:2009/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY

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

    ISO 12232:2006 Photography Digital still cameras Determination of exposure index, ISO speed ratings, standard output sensitivity, and recommended exposure index
    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
    ISO 15529:2010 Optics and photonics Optical transfer function Principles of measurement of modulation transfer function (MTF) of sampled imaging systems
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO 12233:2017 Photography — Electronic still picture imaging — Resolution and spatial frequency responses
    IEC 61262-5:1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5: Determination of the detective quantum efficiency
    IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
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