• IEC 61303:1994

    Current The latest, up-to-date edition.

    Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

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

    Language(s): 

    Published date:  12-10-1994

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    Clause
    1 General
       1.1 Scope and object
       1.2 Normative references
    2 Definitions
    3 Measurement of INSTRUMENT ACCURACY
       3.1 Primary test method
       3.2 Secondary test method
    4 Measurement Of SYSTEM LINEARITY
       4.1 Primary test methods
       4.2 Secondary test methods
    5 Measurement of system reproducibility
       5.1 Primary test method
       5.2 Secondary test method
       5.3 Evaluation
    6 Measurement Of AIR-DENSITY CHARACTERISTIC
       6.1 Test method
       6.2 Evaluation
    7 Measurement of SAMPLE VOLUME CHARACTERISTIC
       7.1 Test method
       7.2 Evaluation
    8 Measurement of background response
       8.1 Inherent background response - Test method
       8.2 Background response to known radiation field -
            Test method
    9 Measurement of long-term reproducibility
       9.1 Method for measurements of long-term
            reproducibility
    10 Measurement of shielding performance
    11 ACCOMPANYING DOCUMENTS and declaration of performance
    Annex A - Index of defined terms

    Abstract - (Show below) - (Hide below)

    Covers radionuclide calibrators of the well type, with a gas-filled ionization chamber as used in the practice of nuclear medicine. The object of this Standard is to identify the most important characteristics of radionuclide calibrators and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardized way and facilitate comparisons between devices. The contents of the corrigendum of June 2016 have been included in this copy.

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

    Development Note Stability Date: 2028. (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
    DIN 6855-11:2016-08 CONSTANCY TESTING OF NUCLEAR MEDICINE INSTRUMENTS - PART 11: RADIONUCLIDE CALIBRATORS (IEC/TR 61948-4:2006, MODIFIED)
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    IEC TR 61948-4:2006 Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
    PD IEC/TR 61948-4:2007 Nuclear medicine instrumentation. Routine tests Radionuclide calibrators

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

    IEC 61145:1992 Calibration and usage of ionization chamber systems for assay of radionuclides
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
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