EN 60627:2015

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

IEC 60627:2013 is applicable to anti-scatter grids used in medical diagnostic X-ray imaging equipment. Anti-Scatter Grids are used 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. This International Standard specifies the definitions, determination and indication of characteristics of anti-scatter grids. In this standard only linear grids are considered. Since at present only focused grids are used in mammography, this standard is restricted to focused grids where mammographic anti-scatter grids are concerned. This standard is not intended to be applied for acceptance tests. This standard does not cover the homogeneity of performance over the area of a grid. This standard is intended to be applied for the determination of the characteristics of anti-scatter grids under test conditions. These conditions are not usually available at the site of the responsible organization. This third edition cancels and replaces the second edition published in 2001, and constitutes a technical revision. In this revision calcium tungstate phosphor fluorescent screens, which are no longer available, have been replaced by gadolinium oxysulphide (GOS) fluorescent screens. Further, a new quality parameter is introduced: the Image Improvement Factor or Q-factor, which better describes the properties of the anti-scatter grid, especially for digital detector applications. Further differences between this third edition and the previous second edition are: - new instrumentation is prescribed for measurements of the transmission of primary radiation, the transmission of scattered radiation and the transmission of total radiation, because fluorescent screens made of calcium tungstate phosphors are outdated and are no longer available; - the definition of the phantom used for measurements of the transmission of primary radiation, the transmission of scattered radiation and the transmission of total radiation is modified and references to IEC 61267 are omitted; - and the radiation conditions used for the measurements have been adapted and are now the RQR and RQR-M conditions specified in IEC 61267:2005.

Bildgebende Geräte für die Röntgendiagnostik - Kenngrößen von Streustrahlenrastern für die allgemeine Anwendung und für die Mammographie

Équipements de diagnostic par imagerie à rayonnement X - Caractéristiques des grilles antidiffusantes d'usage général et de Mammographie

La CEI 60627:2013 s'applique aux grilles antidiffusantes utilisées dans les équipements médicaux de diagnostic par imagerie à rayonnement X. Les grilles antidiffusantes sont utilisées afin de réduire l'incidence du rayonnement diffusé, en particulier celui émis dans le corps du patient, sur la surface réceptrice de l'image et donc afin d'améliorer le contraste de l'image radiologique potentielle. La présente Norme internationale spécifie les définitions, la détermination et l'indication des caractéristiques des grilles antidiffusantes. La présente norme ne traite que des grilles linéaires. Puisqu'à présent, seules les grilles focalisées sont utilisées en mammographie, la présente norme se limite aux grilles focalisées comprenant des grilles antidiffusantes mammographiques. La présente norme n'est pas destinée à être appliquée aux essais de réception. La présente norme ne couvre pas l'homogénéité des performances sur la surface d'une grille. Il est prévu que la présente norme soit appliquée à la détermination des caractéristiques des grilles antidiffusantes dans des conditions d'essai. Ces conditions ne sont habituellement pas rencontrées sur le site de l'organisme responsable. Cette troisième édition annule et remplace la deuxième édition publiée en 2001 dont elle constitue une révision technique. Dans la présente révision, les écrans fluorescents constitués de phosphore au tungstate de calcium, qui ne sont désormais plus disponibles, ont été remplacés par des écrans fluorescents constitués d'oxysulfure de gadolinium (GOS). Par ailleurs, un nouveau paramètre de qualité est introduit: le facteur d'amélioration de l'image ou facteur Q, qui décrit de manière plus appropriée les propriétés de la grille antidiffusante, notamment pour les applications de détection numériques. Les autres différences entre cette troisième édition et la deuxième édition précédente sont les suivantes: - un nouveau dispositif de mesurage est spécifié pour les mesurages de la transmission du rayonnement primaire, la transmission du rayonnement diffuse et la transmission du rayonnement total, étant donné que les écrans fluorescents constitués de phosphores au tungstate de calcium sont démodés et ne sont dorénavant plus disponibles; - la définition du fantôme utilisé pour les mesurages de la transmission du rayonnement primaire, la transmission du rayonnement diffuse et la transmission du rayonnement total est modifiée et les références à la CEI 61267 sont omises; - et les conditions de rayonnement utilisées pour les mesurages ont été adaptées et constituent désormais les conditions RQR et RQR-M spécifiées dans la CEI 61267:2005.

Diagnostična oprema za rentgensko slikanje - Značilnosti splošnonamenske in mamografske protirazpršilne mrežice

Ta mednarodni standard se uporablja za PROTIRAZPRŠILNE MREŽICE, ki se uporabljajo pri medicinski diagnostični opremi za rentgensko slikanje. PROTIRAZPRŠILNE MREŽICE se uporabljajo za zmanjšanje pojavnosti RAZPRŠENEGA SEVANJA, ki nastaja zlasti v telesu PACIENTA, na SPREJEMNEM PREDELU, tako pa se izboljša kontrast RENTGENSKEGA VZORCA. Ta mednarodni standard določa definicije, določevanje in navedbo značilnosti PROTIRAZPRŠILNIH MREŽIC. V tem standardu so obravnavane samo LINEARNE MREŽICE. Ker se trenutno v mamografiji uporabljajo samo USMERJENE MREŽICE, je ta standard omejen na USMERJENE MREŽICE, ko gre za MAMOGRAFSKE PROTIRAZPRŠILNE MREŽICE. Ta standard ni namenjen uporabi za PRESKUSE SPREJEMLJIVOSTI. Ta standard ne obravnava homogenosti delovanja na predelu mrežice. Ta standard je namenjen uporabi za ugotavljanje značilnosti PROTIRAZPRŠILNIH MREŽIC pod preskusnimi pogoji. Ti pogoji običajno niso na voljo na kraju ODGOVORNE ORGANIZACIJE.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60627:2015 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

Relations

• Replaces: EN 60627:2001 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60627:2002
'LDJQRVWLþQDRSUHPD]DUHQWJHQVNRVOLNDQMH=QDþLOQRVWLVSORãQRQDPHQVNHLQ
PDPRJUDIVNHSURWLUD]SUãLOQHPUHåLFH
Diagnostic X-ray imaging equipment - Characteristics of general purpose and
mammographic anti-scatter grids
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
Ta slovenski standard je istoveten z: EN 60627:2015
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
May 2015
ICS 11.040.50 Supersedes EN 60627:2001
English Version
Diagnostic X-ray imaging equipment - Characteristics of general
purpose and mammographic anti-scatter grids
(IEC 60627:2013)
Équipements de diagnostic par imagerie à rayonnement X - Bildgebende Geräte für die Röntgendiagnostik -
Caractéristiques des grilles antidiffusantes d'usage général Kenngrößen von Streustrahlenrastern für die allgemeine
et de Mammographie Anwendung und für die Mammographie
(IEC 60627:2013) (IEC 60627:2013)
This European Standard was approved by CENELEC on 2015-04-14. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60627:2015 E
Foreword
The text of document 62B/914/FDIS, future edition 3 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 approved by CENELEC as EN 60627:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60627:2001.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60627:2013 was approved by CENELEC as a European
Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Publication Year Title EN/HD Year

IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance

+A1 2012 +A1 2013
+A1/AC 2014
+A12 2014
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance -
+A1 2013 +A1 2013
Collateral Standard: Radiation
+A1/AC 2014
protection in diagnostic X-ray equipment
IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics

Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers
all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling
within the scope of this standard.
IEC 60627 ®
Edition 3.0 2013-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Diagnostic X-ray imaging equipment –

Characteristics of general purpose and mammographic anti-scatter grids

Équipements de diagnostic par imagerie à rayonnement X –

Caractéristiques des grilles antidiffusantes d'usage général et de

mammographie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50 ISBN 978-2-8322-0917-2

– 2 – 60627 © IEC:2013
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
3.1 Grid definitions . 9
3.2 Geometric characteristics . 10
3.3 Physical characteristics . 10
3.4 Other terms . 11
4 Structure of ANTI-SCATTER GRIDS . 12
5 Measurement and determination of physical characteristics . 12
5.1 Method and arrangement for measurement . 12
5.1.1 Determination of physical characteristics . 12
5.1.2 Instrumentation . 13
5.1.3 Phantoms . 14
5.1.4 Arrangements . 14
5.1.5 Radiation conditions . 16
5.1.6 Constancy of source . 16
5.2 Physical characteristics . 16
5.2.1 Measurements for the TRANSMISSION OF PRIMARY RADIATION (T ). 16
p
5.2.2 Measurements for the TRANSMISSION OF SCATTERED RADIATION (T ) . 16
s
5.2.3 Measurements for the TRANSMISSION OF TOTAL RADIATION (T ) . 17
t
5.2.4 Calculation of the GRID SELECTIVITY (Σ) . 17
5.2.5 Calculation of the CONTRAST IMPROVEMENT RATIO (K) . 17
5.2.6 Calculation of the GRID EXPOSURE FACTOR (B) . 17
5.2.7 Calculation of the IMAGE IMPROVEMENT FACTOR (Q) . 17
5.2.8 Accuracy of measurements . 17
6 Requirements for ANTI-SCATTER GRIDS . 18
6.1 Manufacturing tolerances . 18
6.2 Determination of the APPLICATION LIMITS . 18
6.3 Accuracy of characteristics . 18
6.3.1 GRID SELECTIVITY . 18
6.3.2 CONTRAST IMPROVEMENT RATIO . 18
6.3.3 GRID EXPOSURE FACTOR . 18
6.3.4 IMAGE IMPROVEMENT FACTOR . 19
6.4 Markings and ACCOMPANYING DOCUMENTS . 19
6.4.1 Data in ACCOMPANYING DOCUMENTS . 19
6.4.2 Mandatory markings and indications for LINEAR GRIDS . 19
6.4.3 Mandatory markings and indications for FOCUSED GRIDS . 19
6.4.4 Additional mandatory markings and indications . 19
6.4.5 Further requirements . 20
Annex A (normative) Calculation of the APPLICATION LIMITS . 27
Annex B (informative) Influence of scatter fraction on the physical characteristics . 30
Bibliography . 32
Index of defined terms used in this standard . 33

60627 © IEC:2013 – 3 –
Figure 1 – Structure of ANTI-SCATTER GRIDS . 21
Figure 2 – RADIATION DETECTOR . 22
Figure 3 – Measurement arrangement for general purpose ANTI-SCATTER GRIDS with
NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION) . 23
Figure 4 – Measurement arrangement for general-purpose ANTI-SCATTER GRIDS with
BROAD BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION). 24
Figure 5 – Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with
NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION) . 25
Figure 6 – Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with
BROAD BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION). 26
Figure B.1 – Physical characteristics as function of scatter fraction: SELECTIVITY Σ
(dash-dotted line), CONTRAST IMPROVEMENT RATIO K (dotted line), GRID EXPOSURE
B (dashed line), and IMAGE IMPROVEMENT FACTOR Q (solid line) . 31
FACTOR
– 4 – 60627 © IEC:2013
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
DIAGNOSTIC X-RAY IMAGING EQUIPMENT –

Characteristics of general purpose and
mammographic anti-scatter grids

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
...