EN 60627:2001
(Main)Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
Deals with the definitions, determination and indication of characteristics of anti-scatter grids used in diagnostic X-ray imaging equipment, in order to reduce the incidence of scattered radiation, produced particularly in the body of the patient, upon the image reception area and thus to improve the contrast of the X-ray pattern. Only linear grids are considered in this standard. This standard is intended to be applied for the demonstration of the characteristics of anti-scatter grids under test conditions.
Bildgebende Geräte für die Röntgendiagnostik - Kenngrößen von Streustrahlenrastern für die allgemeine Anwendung und für die Mammographie
Equipements de diagnostic par imagerie à rayonnement X - Caractéristiques des grilles antidiffusantes d'usage général et de mammographie
Traite des définitions, de la détermination et de l'indication des caractéristiques des grilles antidiffusantes utilisées dans les équipements de diagnostic par imagerie à rayonnement X, afin de réduire l'influence du rayonnement diffusé produit en particulier dans le corps du patient, sur la surface réceptrice de l'image et d'améliorer ainsi le contraste de l'image radiologique potentielle. Cette norme ne traite que des grilles linéaires. Il est prévu que cette norme soit appliquée à la démonstration des caractéristiques des grilles antidiffusantes dans des conditions d'essai.
Diagnostična oprema za rentgensko slikanje – Značilnosti splošnonamenske in mamografske protirazpršilne mrežice (IEC 60627:2001)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2002
1DGRPHãþD
SIST EN 61953:1998
'LDJQRVWLþQDRSUHPD]DUHQWJHQVNRVOLNDQMH±=QDþLOQRVWLVSORãQRQDPHQVNHLQ
PDPRJUDIVNHSURWLUD]SUãLOQHPUHåLFH,(&
Diagnostic X-ray imaging equipment - Characteristics of general purpose and
mammographic anti-scatter grids (IEC 60627:2001)
Bildgebende Geräte für die Röntgendiagnostik - Kenngrößen von Streustrahlenrastern
für die allgemeine Anwendung und für die Mammographie (IEC 60627:2001)
Equipements de diagnostic par imagerie à rayonnement X - Caractéristiques des grilles
antidiffusantes d'usage général et de mammographie (IEC 60627:2001)
Ta slovenski standard je istoveten z: EN 60627:2001
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60627
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2001
ICS 11.040.50
English version
Diagnostic X-ray imaging equipment -
Characteristics of general purpose and mammographic anti-scatter grids
(IEC 60627:2001)
Equipements de diagnostic par imagerie Bildgebende Geräte
à rayonnement X - für die Röntgendiagnostik -
Caractéristiques des grilles antidiffusantes Kenngrößen von Streustrahlenrastern
d'usage général et de mammographie für die allgemeine Anwendung
(CEI 60627:2001) und für die Mammographie
(IEC 60627:2001)
This European Standard was approved by CENELEC on 2001-11-01. 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, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, 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
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60627:2001 E
Foreword
The text of document 62B/436A/FDIS, future edition 2 of IEC 60627, prepared by SC 62B, Diagnostic
imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-
CENELEC parallel vote and was approved by CENELEC as EN 60627 on 2001-11-01.
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) 2002-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-11-01
Annexes designated "normative" are part of the body of the standard.
In this standard, annexes A, B and ZA are normative.
Annex ZA has been added by CENELEC.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, notes, general statements, exceptions and references: in smaller roman type;
– test specifications: in italic type;
– TERMS DEFINED IN EN 60601-1, IN EN 60788, IN CLAUSE 3 OF THIS STANDARD OR IN OTHER IEC
PUBLICATIONS REFERENCED IN ANNEX B: IN SMALL CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 60627:2001 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60627:2001
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
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 60417 Series Graphical symbols for use on equipment EN 60417 Series
1) 2)
IEC 60601-1 - Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
+ A13 1996
1) 2)
IEC 60788 - Medical radiology - Terminology HD 501 S1 1988
1)
IEC 61223-1 - Evaluation and routine testing in --
medical imaging departments
Part 1: General aspects
1) 2)
IEC 61267 - Medical diagnostic X-ray equipment - EN 61267 1994
Radiation conditions for use in the
determination of characteristics
1)
Undated reference.
2)
Valid edition at time of issue.
NORME CEI
INTERNATIONALE IEC
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2001-08
Equipements de diagnostic par imagerie
à rayonnement X –
Caractéristiques des grilles antidiffusantes
d'usage général et de mammographie
Diagnostic X-ray imaging equipment –
Characteristics of general purpose and
mammographic anti-scatter grids
IEC 2001 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
utilisée sous quelque forme que ce soit et par aucun procédé, any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission in
microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
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Pour prix, voir catalogue en vigueur
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60627 © IEC:2001 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope and object.11
2 Normative references .11
3 Terminology .13
3.1 Degree of requirements .13
3.2 Use of terms.13
3.3 Defined terms.13
4 Structure of ANTI-SCATTER GRIDS .19
5 Measurement and determination of physical characteristics.21
5.1 Method and arrangement for measurement .21
5.2 Physical characteristics .27
6 Requirements for ANTI-SCATTER GRIDS.31
6.1 Manufacturing tolerances .31
6.2 Determination of the APPLICATION LIMITS for PARALLEL GRIDS and FOCUSED GRIDS .31
6.3 Accuracy of characteristics.31
6.4 Marking and ACCOMPANYING DOCUMENTS .33
6.5 Statement of compliance .35
Annex A (normative) Calculation of the APPLICATION LIMITS.49
Annex B (normative) Terminology – Index of defined terms.51
Bibliography.55
Figure 1 – Structure of ANTI-SCATTER GRIDS .37
Figure 2 – RADIATION DETECTOR.39
Figure 3a – Measurement arrangement for general purpose ANTI-SCATTER GRIDS
with NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION).41
Figure 3b – Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with
NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION).43
Figure 4a – Measurement arrangement for general purpose ANTI-SCATTER GRIDS
with BROAD-BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) .45
Figure 4b – Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS
with BROAD-BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) .47
60627 © IEC:2001 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
DIAGNOSTIC X-RAY IMAGING EQUIPMENT –
Characteristics of general purpose and mammographic
anti-scatter grids
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60627 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1978, and constitutes a
technical revision. It also cancels and replaces IEC 61953 published in 1997 which is
incorporated in this standard technically unchanged.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/436A/FDIS 62B/441/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.
Annexes A and B form an integral part of this standard.
60627 © IEC:2001 – 7 –
In this standard, the following print types are used:
– requirements, compliances with which can be tested, and definitions: in roman type;
– explanations, advice, notes, general statements, exceptions and references: in smaller roman type;
– test specifications: in italic type;
– TERMS DEFINED IN IEC 60601-1, IN IEC 60788, IN CLAUSE 3 OF THIS STANDARD OR IN OTHER IEC
PUBLICATIONS REFERENCED IN ANNEX B: IN SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged
until 2007. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
60627 © IEC:2001 – 9 –
INTRODUCTION
The first edition of IEC 60627 was intended for ANTI-SCATTER GRIDS used in general radio-
graphy and is not appropriate for ANTI-SCATTER GRIDS used in mammography. As a
consequence, a complementary standard IEC 61953 was published. During the preparation of
this latter standard, it became clear that a revision of IEC 60627 itself was necessary, and it
was decided to merge together the two standards covering ANTI-SCATTER GRIDS. Wherever
possible, a harmonized approach has been used. Where there are differences in this standa
...
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