EN 61267:2006
(Main)Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined radiation conditions. Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation beam (for example by rare earth filters). This standard deals with methods for generating radiation beams with radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment. Examples of such radiation qualities are radiation beams emerging through the filtration from the X-ray source assembly. radiation conditions represent the more general case, where scattered radiation emerges from an exit surface of a patient or a phantom. This requires a well defined geometrical arrangement.
Medizinische diagnostische Röntgeneinrichtung - Bestrahlungsbedingungen zur Bestimmung von Kenngrößen
Equipement de diagnostic médical à rayonnement X - Conditions de rayonnement pour utilisation dans la détermination des caractéristiques
La présente Norme internationale est applicable aux procédures d'essais qui, pour la détermination des caractéristiques des systèmes ou des composants des équipements à rayonnement X de diagnostic médical, nécessitent des conditions de rayonnement bien définies. Exception faite de la mammographie, la présente norme n'est pas applicable aux conditions dans lesquelles des discontinuités dans l'absorption des rayonnements sont délibérément utilisées en vue de modifier les propriétés du faisceau de rayonnement (par exemple au moyen de filtres aux terres rares). La présente norme traite des méthodes de génération des faisceaux de rayonnement dans des conditions de rayonnement pouvant être utilisées dans les conditions d'essai généralement rencontrées dans les laboratoires d'essai ou dans les installations de fabrication pour la détermination des caractéristiques des équipements à rayonnement X de diagnostic médical. Des exemples de telles qualités de rayonnement sont les faisceaux de rayonnement provenant de la filtration de l'ensemble radiogène à rayonnement X. Les conditions de rayonnement représentent le cas le plus général, où le rayonnement diffusé provient de la surface de sortie d'un patient ou d'un fantôme. Cela nécessite des conditions géométriques bien définies.
Medicinska diagnostična rentgenska oprema - Sevalni pogoji pri ugotavljanju karakteristik (IEC 61267:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI SIST EN 61267:2006
STANDARD
junij 2006
Medicinska diagnostična rentgenska oprema - Sevalni pogoji pri ugotavljanju
karakteristik (IEC 61267:2005)
Medical diagnostic X-ray equipment - Radiation conditions for use in the
determination of characteristics (IEC 61267:2005)
ICS 11.040.50 Referenčna številka
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
EUROPEAN STANDARD
EN 61267
NORME EUROPÉENNE
January 2006
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 61267:1994
English version
Medical diagnostic X-ray equipment –
Radiation conditions for use in the determination of characteristics
(IEC 61267:2005)
Equipement de diagnostic médical Medizinische diagnostische
à rayonnement X – Röntgeneinrichtung –
Conditions de rayonnement Bestrahlungsbedingungen zur
pour utilisation dans la détermination Bestimmung von Kenngrößen
des caractéristiques (IEC 61267:2005)
(CEI 61267:2005)
This European Standard was approved by CENELEC on 2005-12-01. 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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and 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
© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61267:2006 E
Foreword
The text of document 62C/391/FDIS, future edition 2 of IEC 61267, 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 61267
on 2005-12-01.
This European Standard supersedes EN 61267:1994.
The main changes compared to EN 61267:1994 include:
a) introduction of “practical peak voltage” for measuring X-ray tube voltage;
b) introduction of a new procedure for establishing the radiation qualities;
c) inserting of an informative Annex B “Determination of the amount of additional filtration” and a
normative Annex C “Measurement of the practical peak voltage”;
d) revision of radiation qualities and radiation conditions;
e) addition of term definitions.
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) 2006-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-12-01
This European Standard makes reference to International Standards. Where the International Standard
referred to has been endorsed as a European Standard or a home-grown European Standard exists, this
European Standard shall be applied instead. Pertinent information can be found on the CENELEC web
site.
In this standard, the following print types are used:
– requirements proper: roman type;
– test specifications: italic type;
– notes and explanatory matter: small roman type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER
STANDARDS: SMALL CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 61267:2005 was approved by CENELEC as a European
Standard without any modification.
__________
NORME CEI
INTERNATIONALE
IEC
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2005-11
Equipement de diagnostic médical
à rayonnement X –
Conditions de rayonnement pour utilisation dans
la détermination des caractéristiques
Medical diagnostic X-ray equipment –
Radiation conditions for use in the
determination of characteristics
IEC 2005 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
X
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
61267 IEC:2005 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope and object.13
2 Normative references .19
3 Terms and definitions .19
4 Common aspects − Adjustment procedures .23
5 RQR – RADIATION QUALITIES in RADIATION BEAMS emerging from the X-RAY SOURCE
ASSEMBLY.25
6 RQA – RADIATION QUALITIES based on a PHANTOM made up of an aluminium ADDED
FILTER.31
7 RQC – RADIATION QUALITIES based on copper ADDED FILTER .35
8 RQT – RADIATION QUALITIES based on copper ADDED FILTER .37
9 Standard RADIATION CONDITIONS RQN.41
10 Standard RADIATION CONDITIONS RQB.45
11 Standard RADIATION CONDITION RQR-M .47
12 Standard RADIATION CONDITION RQA-M.49
13 Standard RADIATION CONDITIONS RQN-M.51
14 Standard RADIATION CONDITION RQB-M.53
Annex A (informative) Rationale.69
Annex B (informative) Determination of the amount of additional filtration.71
ANNEX C (normative) Measurement of the PRACTICAL PEAK VOLTAGE .75
Annex D (informative) Overview of radiation qualities and radiation conditions .79
Bibliography.81
Index of defined terms .83
61267 IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL DIAGNOSTIC X-RAY EQUIPMENT –
RADIATION CONDITIONS FOR USE IN THE
DETERMINATION OF CHARACTERISTICS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61267 has been prepared by subcommittee 62C: EQUIPMENT for
RADIOTHERAPY, nuclear medicine and RADIATION dosimetry, of IEC technical committee 62:
Electrical EQUIPMENT in medical practice.
This second edition cancels and replaces the first edition published in 1994. It constitutes a
technical revision. The main changes of the second edition of this standard include:
a) introduction of “practical peak voltage” for measuring X-ray tube voltage;
b) introduction of a new procedure for establishing the radiation qualities;
c) inserting of an informative Annex B “Determination of the amount of additional filtration”
and a normative Annex C “Measurement of the practical peak voltage”;
d) revision of radiation qualities and radiation conditions;
e) addition of term definitions.
61267 IEC:2005 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
62C/391/FDIS 62C/393/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– requirements proper: roman type;
– test specifications: italic type;
– notes and explanatory matter: small roman type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN
OTHER STANDARDS: SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
61267 IEC:2005 – 9 –
INTRODUCTION
To establish characteristics, aspects or properties of ASSOCIATED EQUIPMENT or to have
available RADIATION BEAMS for physical and medical investigations, sets of well-defined
RADIATION CONDITIONS can offer an important tool in many situations.
From a regulation and standardization point of view there is a need:
− to have available well-defined RADIATION CONDITIONS that can be used internationally to
specify standards of operation of X-RAY EQUIPMENT;
− to provide a basis for the harmonization of existing national standards;
− to provide uniform sets of RADIATION CONDITIONS (a dictionary of RADIATION CONDITIONS) to
describe and judge the performance of X-RAY EQUIPMENT for the benefit of
MANUFACTURERS, USERS, PATIENTS and health protection authorities;
− to solve
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.