• EN 60601-2-1:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

    Available format(s): 

    Superseded date:  05-08-2021

    Language(s): 

    Published date:  23-10-2015

    Publisher:  European Committee for Standards - Electrical

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

    FOREWORD
    INTRODUCTION
    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
    206 Usability
    Annexes
    Annex B (informative) - Sequence of testing
    Annex I (informative) - ME SYSTEMS aspects
    Bibliography
    Index of defined terms
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
              Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions: - alignment with the new relevant collateral standards; - new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

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

    I.S. EN 60976:2007 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    BS EN 60601-2-29 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
    VDE 0750-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    DIN EN 60601-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    BS EN 60976 : 2008 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    CEI EN 60976 : 2009 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
    EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
    BS EN 61217:2012 Radiotherapy equipment. Coordinates, movements and scales
    DIN 6814-8:2016-08 TERMS IN THE FIELD OF RADIOLOGICAL TECHNIQUE - PART 8: RADIOTHERAPY
    EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    EN 60601-2-29:2008/A11:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS

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

    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
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