• IEC 62494-1:2008

    Current The latest, up-to-date edition.

    Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography

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

    Language(s):  English - French, Spanish, Castilian

    Published date:  13-08-2008

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
      4.1 Creation of ORIGINAL DATA
      4.2 Determination of the RELEVANT IMAGE REGION and the
          VALUE OF INTEREST
      4.3 Requirements for the EXPOSURE INDEX
      4.4 Calibration of the EXPOSURE INDEX
      4.5 Determination of the CALIBRATION FUNCTION
      4.6 Determination of the INVERSE CALIBRATION FUNCTION
      4.7 Requirements for the DEVIATION INDEX
    Annex A (informative) Details on the rationale, properties
                          and use of the EXPOSURE INDEX
    Annex B (informative) Details on the rationale, properties
                           and use of the DEVIATION INDEX
    Annex C (normative) Beam conditions to be used for calibration
    Bibliography
    Terminology - Index of defined terms

    Abstract - (Show below) - (Hide below)

    IEC 62494-1:2008 specifies definitions and requirements for the exposure index of images acquired with digital X-ray imaging systems. IEC 62494-1:2008 is applicable to digital X-ray imaging systems used in general radiography for producing projection X-ray images for general applications, such as, but not exclusively:
    - computed radiography (CR) systems based on stimulable phosphors;
    - flat-panel detector based systems;
    - charge-coupled device (CCD) based systems.
    Image intensifier based systems and systems for mammographic or dental application are not covered in this first edition. IEC 62494-1:2008 defines the exposure index only for images generated with a single irradiation event. Images generated from multiple irradiations (e.g., tomosynthetic or dual-energy images, multiple views on a single CR plate) are not covered.

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    Committee TC 62/SC 62B
    Development Note Stability Date: 2020. (09/2017)
    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
    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
    NEMA PS3.3 : 2017A DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS
    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

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

    ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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
    IEC 62220-1:2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    ISO 9236-1:2004 Photography Sensitometry of screen/film systems for medical radiography Part 1: Determination of sensitometric curve shape, speed and average gradient
    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
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