• CSA C22.2 No. 60601-2-28 : 2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-07-2021

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  Canadian Standards Association

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

    FOREWORD
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
           and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation
           HAZARDS
    201.11 Protection against excessive temperatures and other
           HAZARDS
    201.12 Accuracy of controls and instruments and protection
           against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
           SYSTEMS
    203 RADIATION protection in diagnostic X-RAY EQUIPMENT
    Annexes
    Annex AA (informative) - Test of X-RAY TUBE ASSEMBLIES for
                             pressure-related RISKS
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: - hereafter referred to as ME EQUIPMENT; and - intended for medical diagnosis and imaging.

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

    Development Note Supersedes CSA C22.2.601.2.28. (04/2012)
    Document Type Standard
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

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

    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    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 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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