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  • EN 60601-2-68:2015

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

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    Published date:  29-05-2015

    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 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
    201.101 Reference data for X-IGRT
    201.102 X-IGRT IMAGING
    201.103 IGRT analysis and correction
    203 RADIATION protection in diagnostic X-RAY EQUIPMENT
    206 Usability
    Annex B (informative) - Sequence of testing
    Annex I (informative) - ME SYSTEMS aspects
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Measuring CTDIfree air
    Bibliography
    Index of defined terms used in this standard
    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 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

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

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

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

    BS EN 60601-2-64:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
    EN 60601-2-64:2015 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

    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
    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    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)
    IEC 60731:2011+AMD1:2016 CSV Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
    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 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    IEC 61262-7:1995 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
    IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
    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
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    IEC 62563-1:2009+AMD1:2016 CSV Medical electrical equipment - Medical image display systems - Part1: Evaluation methods
    EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    IEC 62220-1:2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    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
    EN 61262-7:1995 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
    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 60601-2-1:2009+AMD1:2014 CSV 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
    HD 60364-7-710:2012/AC:2013 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS
    EN 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    EN 62563-1:2010/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL IMAGE DISPLAY SYSTEMS - PART 1: EVALUATION METHODS (IEC 62563-1:2009/A1:2016)
    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
    IEC 62396-1:2016 Process management for avionics - Atmospheric radiation effects - Part 1: Accommodation of atmospheric radiation effects via single event effects within avionics electronic equipment
    EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    ISO 9334:2007 Optics and photonics Optical transfer function Definitions and mathematical relationships
    EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
    EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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