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EN 60976:2007

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

Published date

07-12-2007

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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
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
Index of defined terms

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.

Committee
CLC/TC 62
DevelopmentNote
Supersedes HD 583. (11/2001) Together with IEC TR 60977, is to be read in conjunction with EN 60601-2-1. (02/2008)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

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
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
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
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
I.S. EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV))
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
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
EN 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
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
EN 60580:2000 Medical electrical equipment - Dose area product meters
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

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