EN 60976:2007
(Main)Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
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.
Medizinische elektrische Geräte - Medizinische Elektronenbeschleuniger - Apparative Qualitätsmerkmale
Appareils électromédicaux - Accélérateurs médicaux d'électrons - Caractéristiques fonctionnelles de performance
S'applique aux accélérateurs médicaux d'électrons utilisés à des fins thérapeutiques, en médecine humaine. Cette norme s'applique aux accélérateurs médicaux d'électrons délivrant un faisceau de rayonnement soit rayonnement X soit rayonnement électronique avec des énergies nominales comprises dans l'intervalle de 1 MeV à 50 MeV avec un débit de dose absorbée maximum de 0,001 Gy s-1 à 1 Gy s-1 à 1 m de la source de rayonnement et à une distance normale de traitement entre 50 cm et 200 cm de la source de rayonnement. La présente norme décrit des mesures et des méthodes d'essai à réaliser par le fabricant au moment de la conception et de la construction d'un accélérateur médical d'électrons mais elle ne spécifie pas les essais de réception devant être effectués après l'installation sur le site de l'acheteur. Cependant, le rapport d'accompagnement CEI 60977 suggère que de nombreuses méthodes d'essai sont applicables aux essais de réception. Les conditions de mesure décrites dans la présente norme ne sont pas identiques à celles précédemment en usage. Cela s'applique en particulier à la position du fantôme pour les mesures et à la mesure des distances à partir de l'isocentre. Il convient que ces nouvelles conditions remplacent les précédentes et ne s'y ajoutent pas. Cette norme spécifie les méthodes d'essai pour la détermination et la déclaration des caractéristiques fonctionnelles dont la connaissance est nécessaire pour une application et une utilisation correctes d'un accélérateur médical d'électrons. Elles doivent être déclarées dans les documents d'accompagnement ainsi que les écarts ou variations maximum auxquels on peut s'attendre dans les conditions définies d'utilisation normale. Un modèle pour la présentation des valeurs des caractéristiques fonctionnelles est donné à l'Annexe A. Il est nécessaire de tenir compte de l'imprécision des méthodes de mesure dans la détermination des caractéristiques. Cependant, il n'a pas semblé souhaitable d'inclure les erreurs dans une tolérance globale, mais de les séparer, espérant que des méthodes de mesure plus précises soient mises au point. Il n'est pas dans le but de cette norme d'empêcher, de quelque façon que ce soit le développement futur d'équipements de conception nouvelle qui pourraient avoir des modes de fonctionnement et des paramètres différents de ceux décrits ci-après, à condition que de tels équipements conduisent à des caractéristiques fonctionnelles de niveau équivalent pour le traitement des patients. Sauf indication contraire, la présente norme s'applique aux accélérateurs médicaux d'électrons avec support isocentrique. Si l'équipement est non isocentrique, la description des caractéristiques et les méthodes d'essai peuvent nécessiter d'être convenablement adaptées. Cette deuxième édition annule et remplace la première édition publiée en 1989 dont elle constitue une révision technique. Cette deuxième édition comprend l'ajout de normes de performances et de méthodes d'essai en rapport avec les technologies nouvelles suivantes: - techniques de transmission du faisceau dynamiques, telles que la radiothérapie cinétique, la radiothérapie de conformation avec modulation d'intensité de dose (IMRT), la radiothérapie assistée par imagerie médicale (IGRT), et les faisceaux avec filtres en coin programmables (PWF); - radiotherapie stéréotaxique (SRT)/ radiochirurgie stéréotaxique (SRS); - utilisation de dispositifs d'imagerie électroniques. Il convient de lire cette norme ainsi que la CEI TR 60977 conjointement à la CEI 60601-2-1.
Medicinska električna oprema - Medicinski elektronski pospeševalniki - Funkcijske tehnične karakteristike (IEC 60976:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2008
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SIST EN 60976:2002
SIST EN 60976:2002/A1:2002
0HGLFLQVNDHOHNWULþQDRSUHPD0HGLFLQVNLHOHNWURQVNLSRVSHãHYDOQLNL)XQNFLMVNH
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Medical electrical equipment - Medical electron accelerators - Functional performance
characteristics (IEC 60976:2007)
Medizinische elektrische Geräte - Medizinische Elektronenbeschleuniger - Apparative
Qualitätsmerkmale (IEC 60976:2007)
Appareils électromédicaux - Accélérateurs médicaux d'électrons - Caractéristiques
fonctionnelles (IEC 60976:2007)
Ta slovenski standard je istoveten z: EN 60976:2007
ICS:
11.040.50
13.280
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60976
NORME EUROPÉENNE
December 2007
EUROPÄISCHE NORM
ICS 11.040.50; 13.280 Supersedes EN 60976:1999 + A1:2000
English version
Medical electrical equipment -
Medical electron accelerators -
Functional performance characteristics
(IEC 60976:2007)
Appareils électromédicaux - Medizinische elektrische Geräte -
Accélérateurs médicaux d'électrons - Medizinische Elektronenbeschleuniger -
Caractéristiques fonctionnelles
Apparative Qualitätsmerkmale
de performance (IEC 60976:2007)
(CEI 60976:2007)
This European Standard was approved by CENELEC on 2007-11-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60976:2007 E
Foreword
The text of document 62C/429/FDIS, future edition 2 of IEC 60976, prepared by SC 62C, Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical
practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60976
on 2007-11-01.
This European Standard supersedes EN 60976:1999 + A1:2000.
new technologies:
– dynamic beam delivery techniques, such as
• MOVING BEAM RADIOTHERAPY,
• INTENSITY-MODULATED RADIATION THERAPY (IMRT),
• IMAGE-GUIDED RADIOTHERAPY (IGRT) and
• PROGRAMMABLE WEDGE FIELDS (PWF);
STEREOTACTIC RADIOTHERAPY STEREOTACTIC RADIOSURGERY
– (SRT) / (SRS);
– use of ELECTRONIC IMAGING DEVICES.
This standard, together with IEC/TR 60977, is to be used in conjunction with EN 60601-2-1.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-11-01
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, general statements, exceptions and notes: in small roman type;
– test specifications and headings of sub-clauses: in italic type;
TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED
–
TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60976:2007 was approved by CENELEC as a European
Standard without any modification.
__________
– 3 – EN 60976:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60580 2000 Medical electrical equipment - Dose area EN 60580 2000
product meters
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC 60601-2-1 1998 Medical electrical equipment - EN 60601-2-1 1998
A1 2002 Part 2-1: Particular requirements for the A1 2002
safety of electron accelerators in the range of
1 MeV to 50 MeV
IEC/TR 60788 2004 Medical electrical equipment - Glossary of – –
defined terms
1)
IEC 60977 – Medical electrical equipment - Medical – –
electron accelerators in the range of 1 MeV to
50 MeV - Guidelines for functional
performance characteristics
1) 2)
IEC 61217 – Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
IEC 61223-1 1993 Evaluation and routine testing in medical – –
imaging departments -
Part 1: General aspects
1)
Undated reference.
2)
Valid edition at date of issue.
IEC 60976
Edition 2.0 2007-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Medical electron accelerators – Functional
performance characteristics
Appareils électromédicaux – Accélérateurs médicaux d’électrons –
Caractéristiques fonctionnelles de performance
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XD
CODE PRIX
ICS 11.040.50; 13.280 ISBN 2-8318-9314-3
– 2 – 60976 © IEC:2007
CONTENTS
FOREWORD.6
INTRODUCTION.8
1 Scope.9
2 Normative references .10
3 Terms and definitions .10
4 Environmental conditions.14
4.1 General .14
4.2 Transport and storage .14
4.3 Power supply.14
5 General information to the USER .14
5.1 Functional performance characteristics .14
5.2 Available nominal energies and ABSORBED DOSE RATES .14
5.3 Available RADIATION FIELDS .15
5.4 NORMAL TREATMENT DISTANCE.15
5.5 Available WEDGE X-RAY FIELDS .15
5.6 Available flattening FILTERS .15
5.7 Availability.16
5.8 Influencing quantities .16
5.9 Maintenance.16
5.10 Presentation.16
5.11 Dimensions, clearances, within the RADIATION HEAD, and in the region
RADIATION HEAD to ISOCENTRE, of BEAM LIMITING DEVICES .16
5.12 IMRT .16
6 Standardized test conditions.17
6.1 General .17
6.2 Angle settings .17
6.3 Properties and positioning of the PHANTOM .17
6.4 Positioning of measuring points.17
6.5 RADIATION DETECTORS .17
6.6 STANDARD MEASUREMENT DEPTHS.18
6.7 RADIATION FIELDS .18
6.8 Adjustments during test.18
6.9 Use of RADIOGRAPHIC FILM or alternative imaging method.18
7 DOSE MONITORING SYSTEM .18
7.1 General .18
7.2 Reproducibility .19
7.3 Proportionality.20
7.4 Dependence on angular positions.21
7.5 Dependence on GANTRY rotation.22
7.6 Dependence on the shape of the RADIATION FIELD .22
7.7 Stability of calibration .23
7.8 Stability in MOVING BEAM RADIOTHERAPY.25
8 Depth ABSORBED DOSE characteristics .26
8.1 X-RADIATION.26
8.2 ELECTRON RADIATION .28
60976 © IEC:2007 – 3 –
9 Uniformity of RADIATION FIELDS .31
9.1 X-RADIATION.31
9.2 ELECTRON RADIATION .36
9.3 PENUMBRA of RADIATION FIELDS.38
10 Indication of RADIATION FIELDS.39
10.1 X-RADIATION.39
10.2 ELECTRON RADIATION .45
10.3 Geometry and motion speeds of adjustable BLDs for X-RADIATION and
ELECTRON RADIATION .46
10.4 Illuminance and PENUMBRA of the LIGHT FIELD.47
11 Indication of the RADIATION BEAM AXIS.48
11.1 General .48
11.2 Indication on entry to the PATIENT .49
11.3 Indication on exit from the PATIENT .51
12 ISOCENTRE .52
12.1 Displacement of the RADIATION BEAM AXIS from the ISOCENTRE .52
12.2 Indication of the ISOCENTRE .53
13 Indication of distance along the RADIATION BEAM AXIS .53
13.1 Indicating device .53
13.2 Additional indicating device for equipment with variable distance between
RADIATION SOURCE and ISOCENTRE a
...
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