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  • IEC 62563-1:2009+AMD1:2016 CSV

    Current The latest, up-to-date edition.

    Medical electrical equipment - Medical image display systems - Part1: Evaluation methods

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

    Language(s):  English - French

    Published date:  24-03-2016

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 62563-1:2009+A1:2016 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard. This consolidated version consists of the first edition (2009) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.

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

    Committee TC 62/SC 62B
    Development Note Stability Date: 2016. (04/2016)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current

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

    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
    PD IEC/TS 62736:2016 Ultrasonics. Pulse-echo scanners. Simple methods for periodic testing to verify stability of an imaging system’s elementary performance
    17/30362279 DC : 0 BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT
    DIN 6868-157 E : 2014 IMAGE QUALITY ASSURANCE IN DIAGNOSTIC XRAY DEPARTMENTS - PART 157: XRAY ORDINANCE ACCEPTANCE AND CONSTANCY TEST OF IMAGE DISPLAY SYSTEMS IN THEIR ENVIRONMENT
    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
    NEMA PS3.3 : 2017A DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS
    NEMA PS 3.16 : 2017A DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 16: CONTENT MAPPING RESOURCE
    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
    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
    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
    DIN 6868-157:2014-11 Image quality assurance in diagnostic X-ray departments - Part 157: X-ray ordinance acceptance and constancy test of image display systems in their environment
    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
    I.S. EN 61391-1:2006 ULTRASONICS - PULSE-ECHO SCANNERS - PART 1: TECHNIQUES FOR CALIBRATING SPATIAL MEASUREMENT SYSTEMS AND MEASUREMENT OF SYSTEM POINT-SPREAD FUNCTION RESPONSE
    17/30341818 DC : 0 BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    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
    IEC TS 62736:2016 Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance
    IEC 61391-1:2006+AMD1:2017 CSV Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of point-spread function response
    14/30250927 DC : 0 BS IEC 62736 - ULTRASONICS - PULSE-ECHO SCANNERS - QUALITY CONTROL OF DIAGNOSTIC MEDICAL ULTRASOUND SYSTEMS - SIMPLE METHODS FOR PERIODIC TESTING TO VERIFY STABILITY OF AN IMAGING SYSTEM'S ELEMENTARY PERFORMANCE
    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 61391-1:2006/A1:2017 ULTRASONICS - PULSE-ECHO SCANNERS - PART 1: TECHNIQUES FOR CALIBRATING SPATIAL MEASUREMENT SYSTEMS AND MEASUREMENT OF SYSTEM POINT-SPREAD FUNCTION RESPONSE (IEC 61391-1:2006/A1:2017)

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

    ISO 9241-307:2008 Ergonomics of human-system interaction — Part 307: Analysis and compliance test methods for electronic visual displays
    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO 9241-305:2008 Ergonomics of human-system interaction — Part 305: Optical laboratory test methods for electronic visual displays
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO 11664-1:2007 Colorimetry Part 1: CIE standard colorimetric observers
    ISO 9241-303:2011 Ergonomics of human-system interaction — Part 303: Requirements for electronic visual displays
    DIN 5031-3:1982-03 OPTICAL RADIATION PHYSICS AND ILLUMINATING ENGINEERING; QUANTITIES, SYMBOLS AND UNITS OF ILLUMINATING ENGINEERING
    IEC 61223-2-5:1994 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices
    ISO 9241-302:2008 Ergonomics of human-system interaction — Part 302: Terminology for electronic visual displays
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