• CSA C22.2 No. 60601.2.7 : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-10-2014

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

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

    FOREWORD
    SECTION 1: GENERAL
    Clause
    1 Scope and object
       1.1 Scope
       1.2 Object
       1.3 Particular Standards
    2 Terminology and definitions
       2.101 Qualifying conditions for defined terms
    3 General requirements
    5 Classification
    6 Identification, marking and documents
       6.1 Marking on the outside of EQUIPMENT or
            EQUIPMENT parts
       6.7 Indicator lights and push-buttons
       6.8 ACCOMPANYING DOCUMENTS
    SECTION 2: ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    15 Limitation of voltage and/or energy
    16 ENCLOSURES and PROTECTIVE COVERS
    19 Continuous LEAKAGE CURRENTS AND PATIENT AUXILIARY
       CURRENTS
       19.3 Allowable values
    20 Dielectric strength
       20.3 Values of test voltages
       20.4 Tests
    SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
    SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
    EXCESSIVE RADIATION
    29 X-RADIATION
        29.1 X-RADIATION generated by diagnostic X-RAY GENERATORS
             containing HIGH-VOLTAGE GENERATORS
    36 Electromagnetic compatibility
    SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
    FLAMMABLE ANAESTHETIC MIXTURES
    SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
    OTHER SAFETY HAZARDS
    42 Excessive temperatures
    SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
    HAZARDOUS OUTPUT
        50 Accuracy of operating data
        50.1 Protection against hazardous output
        50.101 Indication of electric and RADIATION output
        50.102 Reproducibility, linearity and constancy
        50.103 Accuracy of LOADING FACTORS
        50.104 Test conditions
        50.105 Conditions for measuring AIR KERMA
    51 Protection against hazardous output
    SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS:
    ENVIRONMENTAL TESTS
    SECTION 10: CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
        56.7 Batteries
    57 MAINS PARTS, components and layout
        57.10 CREEPAGE DISTANCES and AIR CLEARANCES
        Figures
    101 Recommended arrangement for measuring AIR KERMA
    102 Recommended arrangement for film density testing
         AUTOMATIC CONTROL SYSTEMS provided with a
         TRANSMISSION CHAMBER
    Annexes
    AA Terminology - Index of defined terms
    BB Values of the series R'10 and R'20, ISO 497
    CC Choosing LOADING FACTORS for tests

    Abstract - (Show below) - (Hide below)

    Applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS and their subassemblies including the following: - HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY - HIGH-VOLTAGE GENERATORS of radiotherapy treatment simulators.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded

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

    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
    ISO 3665:2011 Photography Intra-oral dental radiographic film and film packets Manufacturer specifications
    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
    IEC 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
    IEC 60601-2-15:1988 Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
    ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60417P:1997 Fifteenth supplement
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
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