Skip to content
Please enter a keyword to search

  • EN 60336:2005

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

    Available format(s): 

    Superseded date:  12-02-2021

    Language(s): 

    Published date:  07-07-2005

    Publisher:  European Committee for Standards - Electrical

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

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

    FOREWORD
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Determinations for the evaluation of the FOCAL SPOT
       characteristics
       4.1 Statement of the FOCAL SPOT characteristics
       4.2 Longitudinal axis of the X-RAY TUBE ASSEMBLY
       4.3 REFERENCE AXIS of the X-RAY TUBE ASSEMBLY
       4.4 Direction of evaluation for the FOCAL SPOT length
       4.5 Direction of evaluation for the FOCAL SPOT width
    5 FOCAL SPOT camera set-up
       5.1 Overview
       5.2 Test equipment
       5.3 Test arrangement
       5.4 Total uncertainty of the camera set-up
    6 Production of RADIOGRAMS
       6.1 Overview
       6.2 Operating conditions
       6.3 Production of FOCAL SPOT SLIT RADIOGRAMS or FOCAL
           SPOT PINHOLE RADIOGRAMS
       6.4 Statement of compliance
    7 Determination of the LINE SPREAD FUNCTION
       7.1 Overview
       7.2 Measuring equipment and measuring arrangement
       7.3 Measurement of the density distribution
       7.4 Determination of the LINE SPREAD FUNCTION
       7.5 Statement of compliance
    8 Determination of FOCAL SPOT dimensions
       8.1 Overview
       8.2 Measurement and determination
       8.3 Specified NOMINAL FOCAL SPOT VALUES
       8.4 Statement of compliance
       8.5 Marking of compliance
    9 Determination of the MODULATION TRANSFER FUNCTION
       9.1 Overview
       9.2 Specified MODULATION TRANSFER FUNCTION
       9.3 Calculation of the MODULATION TRANSFER FUNCTION
       9.4 Evaluation of compliance of the MTF
       9.5 Statement of compliance
    10 FOCAL SPOT STAR RADIOGRAMS
       10.1 Overview
       10.2 Test equipment
    11 STAR PATTERN RESOLUTION LIMIT
       11.1 Overview
       11.2 Specified STAR PATTERN RESOLUTION LIMIT
       11.3 Measurement
       11.4 Determination of the STAR PATTERN RESOLUTION LIMIT
       11.5 Evaluation and statement of compliance
    12 BLOOMING VALUE
       12.1 Overview
       12.2 Determination of the BLOOMING VALUE
       12.3 Evaluation and statement of compliance
    13 Alternate measurement methods
    Annex A (informative) Alignment to the REFERENCE AXIS
    Annex B (informative) Application of digital X-ray image
                           detectors for determination of the
                           FOCAL SPOT characteristics
    Annex C (informative) Historical background
    Annex ZA (normative) Normative references to international
                           publications with their corresponding
                           European publications
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to focal spots in medical diagnostic X-ray tube assemblies or medical use, operating at X-ray tube voltages up to and including 200 kV. Describes the test methods for evaluating focal spot characteristics and the means for indicating compliance.

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

    Committee CLC/TC 62
    Development Note Supersedes HD 509 (07/2005)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

    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
    CEI EN 60406 : 1998 CASSETTES FOR MEDICAL X-RAY DIAGNOSIS RADIOGRAPHIC CASSETTES AND MAMMOGRAPHIC CASSETTES
    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
    BS EN 50631-1:2017 Household appliances network and grid connectivity General Requirements, Generic Data Modelling and Neutral Messages
    CEI EN 61262-7 : 1997 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 7: DETERMINATION OF THE MODULATION TRANSFER FUNCTION
    EN 60406:1997 Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes
    BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment
    EN 60601-2-63:2015 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral 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
    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 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    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)
    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 60601-2-45 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    BS EN 62220-1:2004 Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency
    CEI EN 60601-2-28 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    BS EN 60601-2-28:2010 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    CEI EN 62220-1-1 : 2016 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING
    I.S. EN 60406:1998 CASSETTES FOR MEDICAL X-RAY DIAGNOSIS - RADIOGRAPHIC CASSETTES AND MAMMOGRAPHIC CASSETTES
    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))
    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)
    BS EN 60601-2-63:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    BS EN 60406:1997 Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis
    EN 62220-1-1:2015 Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging
    I.S. EN 60601-2-63:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT
    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
    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
    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
    BS EN 62220-1-1:2015 Medical electrical equipment. Characteristics of digital x-ray imaging devices Determination of the detective quantum efficiency. Detectors used in radiographic imaging
    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
    BS EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
    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 60601-2-28:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    I.S. EN 62220-1-1:2015 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING
    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 50631-1:2017 HOUSEHOLD APPLIANCES NETWORK AND GRID CONNECTIVITY - PART 1: GENERAL REQUIREMENTS, GENERIC DATA MODELLING AND NEUTRAL MESSAGES
    EN 50631-1:2017 Household appliances network and grid connectivity - Part 1: General Requirements, Generic Data Modelling and Neutral Messages
    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
    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
    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)
    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
    I.S. EN 60601-2-45:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    I.S. EN 62220-1:2004 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY
    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
    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
    I.S. EN 61262-7:1997 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 7: DETERMINATION OF THE MODULATION TRANSFER FUNCTION
    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 60601-2-45:2011/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015)
    EN 61262-7:1995 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
    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
    EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    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
    UNE-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

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

    EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
    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 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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective