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  • IEC 60601-2-28:2017

    Current The latest, up-to-date edition.

    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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French

    Published date:  16-06-2017

    Publisher:  International Electrotechnical Committee

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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 for ME
           EQUIPMENT
    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 expelled parts-related and/or tube
             implosion-related RISKS
    Bibliography
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    IEC 60601-2-28:2017 is also available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

    IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.

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

    Committee TC 62/SC 62B
    Development Note Supersedes IEC 60637. (03/2001) Stability Date: 2022. (06/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
    EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
    EN 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    I.S. EN 60601-2-65:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV))
    EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
    EN 60601-2-17:2015 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    IEEE/ANSI N42.47-2010 American National Standard for Measuring the Imaging Performance of X-ray and Gamma-ray Systems for Security Screening of Humans
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    EN 60601-2-54:2009/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    I.S. EN 61223-2-6:2007 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    I.S. EN 60601-2-65:2013/A1:2020 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017)
    EN 60601-2-45:2011/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015)
    BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 60336:2005 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots
    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
    IEC 60601-2-65:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    CSA C22.2 No. 60601.2.17 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 60601-2-7:1998 Medical electrical equipment. Particular requirements for safety Specification for high voltage generators of diagnostic X-ray generators
    IEC 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    CSA C22.2 No. 60601-2-63 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    BS EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 61223-3-4:2000 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
    IEC 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    BS EN 60601-2-45 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    BS EN 61223-3-4:2000 Evaluation and routine testing in medical imaging departments Acceptance tests
    BS EN 60601-2-17:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    UNE-EN 60601-2-54:2010 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    EN 60601-2-63:2015 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    BS EN 60601-2-65:2013 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
    CAN/CSA-C22.2 No. 60601-2-65 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    BS EN 60601-2-63:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment
    IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
    IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    BS EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    VDE 0750-2-7 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
    BS 6530(1994) : 1994 AMD 8835 METHODS FOR DETERMINING THE CHARACTERISTICS OF FOCAL SPOTS IN DIAGNOSTIC X-RAY TUBE ASSEMBLIES FOR MEDICAL USE
    DIN EN 60601-2-7 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
    BS EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment
    BS EN 60601-1-3 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)
    EN 60601-2-65:2013 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    IEC 60601-2-63:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    IEC 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    PD IEC/TR 60601-4-3:2015 Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    IEEE N42.44-2008 American National Standard for the Performance of Checkpoint Cabinet X-Ray Imaging Security Systems
    IEEE/ANSI N42.55-2013 American National Standard for the Performance of Portable Transmission X-Ray Systems for Use in Improvised Explosive Device and Hazardous Device Identification
    I.S. EN 60336:2005 MEDICAL ELECTRICAL EQUIPMENT - X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS - CHARACTERISTICS OF FOCAL SPOTS

    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
    ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
    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 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    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
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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