• IEC 60976:2007

    Current The latest, up-to-date edition.

    Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

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

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

    Published date:  16-10-2007

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Environmental conditions
       4.1 General
       4.2 Transport and storage
       4.3 Power supply
    5 General information to the USER
       5.1 Functional performance characteristics
       5.2 Available nominal energies and ABSORBED DOSE RATES
       5.3 Available RADIATION FIELDS
       5.4 NORMAL TREATMENT DISTANCE
       5.5 Available WEDGE X-RAY FIELDS
       5.6 Available flattening FILTERS
       5.7 Availability
       5.8 Influencing quantities
       5.9 Maintenance
       5.10 Presentation
       5.11 Dimensions, clearances, within the RADIATION HEAD, and
            in the region RADIATION HEAD to ISOCENTRE, of BEAM
            LIMITING DEVICES
       5.12 IMRT
    6 Standardized test conditions
       6.1 General
       6.2 Angle settings
       6.3 Properties and positioning of the PHANTOM
       6.4 Positioning of measuring points
       6.5 RADIATION DETECTORS
       6.6 STANDARD MEASUREMENT DEPTHS
       6.7 RADIATION FIELDS
       6.8 Adjustments during test
       6.9 Use of RADIOGRAPHIC FILM or alternative imaging method
    7 DOSE MONITORING SYSTEM
       7.1 General
       7.2 Reproducibility
       7.3 Proportionality
       7.4 Dependence on angular positions
       7.5 Dependence on GANTRY rotation
       7.6 Dependence on the shape of the RADIATION FIELD
       7.7 Stability of calibration
       7.8 Stability in MOVING BEAM RADIOTHERAPY
    8 Depth ABSORBED DOSE characteristics
       8.1 X-RADIATION
       8.2 ELECTRON RADIATION
    9 Uniformity of RADIATION FIELDS
       9.1 X-RADIATION
       9.2 ELECTRON RADIATION
       9.3 PENUMBRA of RADIATION FIELDS
    10 Indication of RADIATION FIELDS
       10.1 X-RADIATION
       10.2 ELECTRON RADIATION
       10.3 Geometry and motion speeds of adjustable BLDs for
            X-RADIATION and ELECTRON RADIATION
       10.4 Illuminance and PENUMBRA of the LIGHT FIELD
    11 Indication of the RADIATION BEAM AXIS
       11.1 General
       11.2 Indication on entry to the PATIENT
       11.3 Indication on exit from the PATIENT
    12 ISOCENTRE
       12.1 Displacement of the RADIATION BEAM AXIS from the
            ISOCENTRE
       12.2 Indication of the ISOCENTRE
    13 Indication of distance along the RADIATION BEAM AXIS
       13.1 Indicating device
       13.2 Additional indicating device for equipment with
            variable distance between RADIATION SOURCE and
            ISOCENTRE and for non-isocentric equipment
    14 Zero position of rotational scales
       14.1 General
       14.2 Information to the USER
       14.3 Tests
    15 Congruence of opposed RADIATION FIELDS
       15.1 Information to the USER
       15.2 Test
    16 Movements of the PATIENT table
       16.1 General
       16.2 Vertical movement of the table
       16.3 ISOCENTRIC rotation of the table
       16.4 Parallelism of table rotational axes
       16.5 Rigidity of the table
    17 ELECTRONIC IMAGING DEVICE (e.g. EPID)
       17.1 Information to the USER
       17.2 Tests
    Annex A (informative) Format for presentation of functional
            performances values
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Applies to medical electron accelerators when used, for therapy purposes, in human medical practice.This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source.The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests.The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods.This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A.It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved.It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients.Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted.This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision.This second edition includes the addition of performance standards and test methods relating to the following new technologies:- dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields;- stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS);- use of electronic imaging devices.This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.

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

    Committee TC 62/SC 62C
    Development Note To be read in conjunction with IEC TR 60977 and IEC 60601-2-1. (10/2007) Stability Date: 2020. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    IEC 60601-2-68:2014 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 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
    BS EN 60601-2-1:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    CSA C22.2 No. 60601.2.1 : 2011 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
    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
    CEI EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    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
    08/30168475 DC : DRAFT APR 2008 BS EN 60601-2-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV
    ISO 16645:2016 Radiological protection — Medical electron accelerators — Requirements and recommendations for shielding design and evaluation
    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))
    10/30206860 DC : 0 BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
    PD IEC/TR 60977:2008 Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics
    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
    12/30246621 DC : 0 BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR 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
    BS EN 60731:2012 Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy
    EN 60601-2-1:2015 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
    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
    CSA C22.2 No. 60601.2.1 : 2011 : INC : AMD 1 : 2015 : R2016 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
    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
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    09/30194820 DC : 0 BS EN 60731 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    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
    I.S. EN 60601-2-1:2015 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
    I.S. EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV))
    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
    BS EN 61217:2012 Radiotherapy equipment. Coordinates, movements and scales
    UNE-EN 60601-2-1:2017 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
    DIN 6814-8:2016-08 TERMS IN THE FIELD OF RADIOLOGICAL TECHNIQUE - PART 8: RADIOTHERAPY
    15/30299908 DC : 0 BS ISO 16645 - RADIOLOGICAL PROTECTION - MEDICAL ELECTRON ACCELERATORS - REQUIREMENTS AND RECOMMENDATIONS FOR SHIELDING DESIGN AND EVALUATION
    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 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

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

    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 TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    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
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