SIST EN 60627:2015

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

This International Standard is applicable to ANTI-SCATTER GRIDS used in medical diagnostic Xray
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 ANTISCATTER
GRIDS under test conditions. These conditions are not usually available at the site of
the RESPONSIBLE ORGANIZATION.

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

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: 16-Aug-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 17-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60627:2015 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

Relations

• Replaces: SIST EN 60627:2002 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60627:2002 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
• Effective Date: 01-Sep-2015
• Replaces: SIST EN 60627:2002 - Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60627:2015
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
SIST EN 60627:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60627:2015

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SIST EN 60627:2015


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

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SIST EN 60627:2015
EN 60627:2015
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.
2

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SIST EN 60627:2015
EN 60627:2015
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

3

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SIST EN 60627:2015
EN 60627:2015
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.
4

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SIST EN 60627:2015




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



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60627:2015
– 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

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SIST EN 60627:2015
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

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SIST EN 60627:2015
– 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 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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 60627 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
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.
IMAGE IMPROVEMENT FACTOR or Q-factor,
Further, a new quality parameter is introduced: the
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:
– some definitions have been modified and others added to improve clarity, harmonization
or generality;

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SIST EN 60627:2015
60627 © IEC:2013 – 5 –
– 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;
– the RADIATION CONDITIONS used for the measurements have been adapted and are now the
RQR and RQR-M conditions specified in IEC 61267:2005;
– tolerances are specified for the dimensions in the arrangements for the measurements of
the TRANSMISSION OF PRIMARY RADIATION, the TRANSMISSION OF SCATTERED RADIATION and
the TRANSMISSION OF TOTAL RADIATION.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/914/FDIS 62B/922/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 and definitions: roman type.
– Test specifications: italic type.
Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative text of
–
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR IN OTHER IEC PUBLICATIONS REFERENCED IN
THIS STANDARD: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g., Clause 5 includes subclauses 5.1, 5.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 5.1, 5.2 and 5.2.1 are all
subclauses of Clause 5).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or”, so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.

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SIST EN 60627:2015
– 6 – 60627 © IEC:2013
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests.
It is the recommendation of the committee that the content of this publication be adopted for implementation
nationally not earlier than 36 months from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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SIST EN 60627:2015
60627 © IEC:2013 – 7 –
INTRODUCTION
The first edition of IEC 60627 was intended for ANTI-SCATTER GRIDS used in general
radiography and is not appropriate for ANTI-SCATTER GRIDS used in mammography. As a
consequence, a complementary standard IEC 61953 was published. Later, it was decided to
revise and merge together the two standards covering ANTI-SCATTER GRIDS. Wherever
possible, a harmonized approach has been used. This constituted the second edition of
IEC 60627 published in 2001.
This third edition is a revision of the second edition. This revision was initiated by the fact that
calcium tungstate phosphors have become obsolete, and are no longer available.
Instrumentation with FLUORESCENT SCREENS made of gadolinium oxysulphide (GOS) is the
present state of the art.
Further, a new quality parameter is introduced: the IMAGE IMPROVEMENT FACTOR Q. This factor
better describes the properties of ANTI-SCATTER GRIDS than the GRID EXPOSURE FACTOR B and
the CONTRAST IMPROVEMENT FACTOR K, especially for digital detector applications. Namely, the
signal-to-noise ratio (SNR) for digital X-ray detectors is increased proportionally with the
square root of the factor Q when an ANTI-SCATTER GRID is applied. This effect is due to the
efficient reduction of SCATTERED RADIATION and overcompensates the loss of PRIMARY
RADIATION when using an ANTI-SCATTER GRID in situations where a considerable amount of
SCATTERED RADIATION is present. The name IMAGE IMPROVEMENT FACTOR is chosen to reflect
the improved image quality (characterized by SNR and other parameters) under equal
RADIATION dose conditions.
Special laboratory provisions and carefully controlled test conditions are needed for the
measurements described here.

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SIST EN 60627:2015
– 8 – 60627 © IEC:2013
DIAGNOSTIC X-RAY IMAGING EQUIPMENT –

Characteristics of general purpose and
mammographic anti-scatter grids



1 Scope
This International Standard 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.
2 Normative references
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.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic
X-ray equipment
Amendment 1:2013
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61267:2005, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012, IEC 60601-1-3:2008+A1:2013, IEC/TR 60788:2004 and the
following apply.

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SIST EN 60627:2015
60627 © IEC:2013 – 9 –
3.1 Grid definitions
3.1.1
ANTI-SCATTER GRID
device to be placed before the IMAGE RECEPTION AREA in order to reduce the incidence of
SCATTERED RADIATION upon that area and thus increase the contrast in the X-RAY PATTERN
3.1.2
LINEAR GRID
ANTI-SCATTER GRID composed of highly absorbing strips and highly transmitting interspaces
which are parallel in their longitudinal direction
3.1.3
PARALLEL GRID
LINEAR GRID in which the planes of the absorbing strips are parallel to each other and
perpendicular to the incident face
3.1.4
FOCUSED GRID
LINEAR GRID in which the planes of the absorbing strips converge to a straight line at the
FOCUSING DISTANCE
3.1.5
TAPERED GRID
LINEAR GRID in which the height of the absorbing strips decreases as the distance between the
absorbing strips and the TRUE CENTRAL LINE increases. This decrease is symmetrical about
the TRUE CENTRAL LINE
3.1.6
CROSS-GRID
ANTI-SCATTER GRID composed of two LINEAR GRIDS built together in such a way that the
directions of their absorbing strips form an angle
3.1.7
ORTHOGONAL CROSS-GRID
CROSS-GRID in which the directions of the absorbing strips form an angle of 90°
3.1.8
OBLIQUE CROSS-GRID
CROSS-GRID in which the directions of the absorbing strips form an angle other than 90°
3.1.9
STATIONARY GRID
ANTI-SCATTER GRID used in such a way that it does not move in relation to the RADIATION BEAM
3.1.10
MOVING GRID
ANTI-SCATTER GRID used in an ACCESSORY that enables the ANTI-SCATTER GRID to be moved,
when irradiated by a RADIATION BEAM, in order to avoid the imaging of the absorbing strips and
the consequent loss of information
3.1.11
MAMMOGRAPHIC ANTI-SCATTER GRID
FOCUSED GRID specially designed for mammography
Note 1 to entry: In this standard the term "general purpose ANTI-SCATTER GRID" is used to describe any ANTI-
SCATTER GRID not specially designed for mammography.

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SIST EN 60627:2015
– 10 – 60627 © IEC:2013
3.2 Geometric characteristics
3.2.1
STRIP FREQUENCY
N
–1
number of absorbing strips per unit length of a LINEAR GRID (unit: cm )
3.2.2
GRID RATIO
r
ratio between the height of the absorbing strips and the distance between the absorbing strips
in the centre of a LINEAR GRID
3.2.3
FOCUSING DISTANCE
f
0
distance between the incident face of a FOCUSED GRID and the line into which the planes of the
absorbing strips of the grid converge (unit: cm)
Note 1 to entry: Attention is drawn to the differences between "FOCUSING DISTANCE", "FOCAL SPOT to grid distance"
and "FOCAL SPOT to film distance".
3.2.4
APPLICATION LIMITS
f , f
1 2
lower, f , and upper, f , limits of the distance from the FOCAL SPOT to the incident face of a
1 2
FOCUSED GRID or a PARALLEL GRID between
...