• IEC 62083:2009

    Current The latest, up-to-date edition.

    Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French, Spanish, Castilian

    Published date:  23-09-2009

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviations
       3.1 Terms and definitions
       3.2 Abbreviations
    4 General
       4.1 Development
       4.2 Testing during installation
    5 ACCOMPANYING DOCUMENTS
    6 General requirements for operational safety
       6.1 Distances and linear and angular dimensions
       6.2 RADIATION quantities
       6.3 Date and time format
       6.4 Protection against unauthorized use
       6.5 Data limits
       6.6 Protection against unauthorized modification
       6.7 Correctness of data transfer
       6.8 Coordinate systems and scales
       6.9 Saving and archiving data
    7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and
       BRACHYTHERAPY SOURCE MODELLING
       7.1 EQUIPMENT MODEL
       7.2 BRACHYTHERAPY SOURCE MODEL
       7.3 Dosimetric information
       7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
            acceptance
       7.5 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
            deletion
    8 ANATOMY MODELLING
       8.1 Data acquisition
       8.2 Coordinate systems and scales
       8.3 Contouring of regions of interest
       8.4 PATIENT ANATOMY MODEL acceptance
       8.5 PATIENT ANATOMY MODEL deletion
    9 TREATMENT PLANNING
       9.1 General requirements
       9.2 TREATMENT PLAN preparation
       9.3 TREATMENT PLAN identification
       9.4 TREATMENT PLAN deletion
       9.5 Electronic signatures
    10 ABSORBED DOSE distribution calculation
       10.1 Algorithms used
       10.2 Accuracy of algorithms
    11 TREATMENT PLAN report
       11.1 Incomplete TREATMENT PLAN report
       11.2 Information on the TREATMENT PLAN report
       11.3 Transmitted TREATMENT PLAN information
    12 General hardware diagnostics
    13 Data and code
    14 Human errors in software design
    15 Change in software versions
    16 USE ERRORS
    Annex A (normative) - Hardware safety
    Annex B (informative) - Imported and exported data
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems:
    - for use in radiotherapy treatment planning in human medical practice;
    - that imports data either through input by the operator or directly from other devices;
    - that outputs data either in printed form for review or directly to other devices;
    and which is intended to be:
    a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
    b) maintained in accordance with the recommendations given in the instructions for use, and
    c) used within the environmental and electrical supply conditions specified in the technical description.
    This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.

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

    Committee TC 62/SC 62C
    Development Note Stability Date: 2019. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    10/30206488 DC : 0 BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    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
    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    BS EN 60601-2-68:2015 Medical electrical equipment 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
    CEI EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
    I.S. 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
    10/30206860 DC : 0 BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    02/564070 DC : DRAFT SEP 2002 BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CSA C22.2 No. 60601-2-68 : 2015 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
    CEI EN 60601-2-17 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    BS EN 60601-2-17:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    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
    I.S. EN 62274:2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    BS EN 62274:2005 Medical electrical equipment. Safety of radiotherapy record and verify systems
    BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
    EN 60601-2-68:2015 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
    EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
    IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
    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
    I.S. EN 60601-2-68:2015 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
    NF EN 60601-2-68 : 2015 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
    EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
    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

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 61000-4-1:2006 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    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
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    IEC 60601-2-11:2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
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