SIST EN 62563-1:2010
(Main)Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (IEC 62563-1:2009)
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (IEC 62563-1:2009)
IEC 62563-1:2009 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard.
Medizinische elektrische Geräte - Medizinische Bildwiedergabesysteme - Teil 1: Bewertungsmethoden (IEC 62563-1:2009)
Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 1: Méthodes d’évaluation (CEI 62563-1:2009)
La CEI 62563-1:2009 décrit les méthodes d'évaluation utilisées pour les essais des systèmes d'imagerie médicale. Elle est destinée aux essais pratiques pouvant faire l'objet d'une évaluation ou d'une mesure visuelle en utilisant un appareillage d'essai de base. Des mesures plus approfondies ou plus quantitatives peuvent être effectuées sur ces dispositifs, ces mesures ne relevant toutefois pas du domaine d'application du présent document. La CEI 62563-1:2009 s'applique aux systèmes d'imagerie médicale qui peuvent afficher des informations sous forme d'images monochromes selon des valeurs d'échelle des gris sur des systèmes d'imagerie couleur et à échelle des gris (par exemple moniteurs a tubes cathodiques, écrans plats, système de projection). La présente norme s'applique aux systèmes d'imagerie médicale utilisés à des fins de diagnostic (interprétation des images médicales en vue d'un diagnostic clinique) ou d'observation (visualisation d'images médicales dans le cadre d'interventions autres que celles destinées à une interprétation médicale), auxquels sont par conséquent associées des exigences spécifiques en termes de qualité de l'image. Les systèmes d'imagerie de tête et les systèmes d'imagerie utilisés pour confirmer le positionnement et pour l'exploitation du système ne sont pas couverts par la présente norme.
Medicinska električna oprema - Sistemi za prikazovanje medicinskih slik - 1. del: Metode vrednotenja (IEC 62563-1:2009)
Ta del IEC 62563 opisuje metode vrednotenja za preskušanje SISTEMOV ZA PRIKAZOVANJE medicinskih SLIK. Področje uporabe tega mednarodnega standarda je usmerjeno v praktične preskuse, ki so lahko vidno ovrednoteni ali merjeni z uporabo osnovne preskusne opreme. Na teh napravah se lahko izvajajo naprednejše ali bolj kvantitativne meritve, vendar so te izven področja uporabe tega dokumenta. Ta standard velja za sisteme za prikazovanje medicinskih slik, ki lahko prikazujejo monokromatične informacije o sliki na način črno-belih vrednosti na barvnih in črno-belih SISTEMIH ZA PRIKAZOVANJE SLIK (npr. monitorji Z KATODNIMI CEVMI (CRT), PLOŠČATI ZASLONI, SISTEM PROJEKCIJE). Ta standard velja za SISTEME ZA PRIKAZOVANJE medicinskih SLIK, ki se uporabljajo za diagnozo (razlaga medicinskih slik za klinično diagnozo) ali ogledovanje (ogledovanje medicinskih slik za druge medicinske namene, kot je zagotavljanje medicinske razlage) in imajo zato določene zahteve glede kvalitete slike. SISTEMI ZA PRIKAZOVANJE SLIK na podstavkih in SISTEMI ZA PRIKAZOVANJE SLIK, ki se uporabljajo za potrjevanje pozicije in za delovanje sistema, niso zajeti v tem standardu. V področju uporabe tega standarda ni določitve zahtev sprejemnih in trajnostnih preskusov niti frekvenc trajnostnih preskusov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2010
0HGLFLQVNDHOHNWULþQDRSUHPD6LVWHPL]DSULND]RYDQMHPHGLFLQVNLKVOLNGHO
0HWRGHYUHGQRWHQMD ,(&
Medical electrical equipment - Medical image display systems - Part 1: Evaluation
methods (IEC 62563-1:2009)
Medizinische elektrische Geräte - Medizinische Bildwiedergabesysteme - Teil 1:
Bewertungsmethoden (IEC 62563-1:2009)
Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 1: Méthodes
d’évaluation (CEI 62563-1:2009)
Ta slovenski standard je istoveten z: EN 62563-1:2010
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 62563-1
NORME EUROPÉENNE
March 2010
EUROPÄISCHE NORM
ICS 11.040.55
English version
Medical electrical equipment -
Medical image display systems -
Part 1: Evaluation methods
(IEC 62563-1:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Systèmes d’imagerie médicale - Medizinische Bildwiedergabesysteme -
Partie 1: Méthodes d’évaluation Teil 1: Bewertungsmethoden
(CEI 62563-1:2009) (IEC 62563-1:2009)
This European Standard was approved by CENELEC on 2010-03-01. 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, Croatia, 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: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62563-1:2010 E
Foreword
The text of document 62B/743/CDV, future edition 1 of IEC 62563-1, 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 62563-1 on 2010-03-01.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
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) 2010-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-03-01
In this standard, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THIS INTERNATIONAL STANDARD, OR AS NOTED: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62563-1:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
[1] ISO 9241-302 NOTE Harmonized as EN ISO 9241-302.
[19] IEC 61223-2-5 NOTE Harmonized as EN 61223-2-5.
[20] ISO 9241-303 NOTE Harmonized as EN ISO 9241-303.
[21] ISO 9241-305 NOTE Harmonized as EN ISO 9241-305.
[22] ISO 9241-307 NOTE Harmonized as EN ISO 9241-307.
__________
- 3 - EN 62563-1:2010
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/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
ISO 11664-1 2007 Colorimetry - - -
Part 1: CIE standard colorimetric observers
CIE S010/E 2004 Photometry - The CIE system of physical - -
photometry
IEC 62563-1 ®
Edition 1.0 2009-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils électromédicaux – Systèmes d’imagerie médicale –
Partie 1: Méthodes d’évaluation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040.55 ISBN 2-8318-1073-5
– 2 – 62563-1 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms, definitions, symbols and abbreviations.7
3.1 Terms and definitions .7
3.2 Symbols .10
3.3 Abbreviations .11
4 General .11
5 Prerequisites .11
6 Equipment and tools.12
6.1 LUMINANCE meter .12
6.2 ILLUMINANCE meter.12
6.3 Colour meter .12
6.4 TEST PATTERNS .13
7 Evaluation methods .14
7.1 General .14
7.2 Evaluation method table overview .14
7.3 Visual evaluation methods.16
7.3.1 General .16
7.3.2 Overall image quality evaluation .16
7.3.3 Greyscale resolution evaluation.17
7.3.4 LUMINANCE response evaluation.18
7.3.5 LUMINANCE uniformity evaluation.19
7.3.6 Chromaticity evaluation .19
7.3.7 Pixel faults evaluation.19
7.3.8 VEILING GLARE evaluation .20
7.3.9 Geometrical image evaluation.20
7.3.10 Angular viewing evaluation .21
7.3.11 Clinical evaluation .22
7.4 Quantitative evaluation methods.22
7.4.1 Basic LUMINANCE evaluation.22
7.4.2 Basic LUMINANCE evaluation without ambient light .23
7.4.3 LUMINANCE response evaluation.23
7.4.4 LUMINANCE evaluation of multiple displays .26
7.4.5 Chromaticity evaluation .26
7.4.6 Chromaticity evaluation of multiple displays.26
7.4.7 LUMINANCE uniformity evaluation.26
7.4.8 Viewing angle evaluation .26
Annex A (informative) Sample test reports .28
Annex B (informative) LUMINANCE measurement methods .43
Annex C (informative) Description of TEST PATTERNS .46
Bibliography.55
Index of defined terms .57
62563-1 © IEC:2009 – 3 –
Figure 1 – Overall image quality evaluation using the TG18-QC TEST PATTERN.16
Figure 2 – Overall image quality evaluation using the TG18-OIQ TEST PATTERN.17
Figure 3 – Magnified view of TG18-MP TEST PATTERN showing the 8-bit and 10-bit
markers .18
Figure 4 – A close-up of the TG18-CT TEST PATTERN.19
Figure 5 – The TG18-GV TEST PATTERN is displayed (left), a close-up of the centre of
the TEST PATTERN when covered with a mask (right) .20
Figure 6 – Geometrical evaluation using the GD pattern .21
Figure 7 – Visual evaluation of viewing angle response .22
Figure 8 – Example of the measured LUMINANCE in relation to the standard LUMINANCE
response function according to GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) .25
Figure 9 – An example of the CONTRAST response computed from 18 grey levels as
related to the expected CONTRAST response associated with the DICOM 3.14 [2]
standard LUMINANCE response with a given tolerance limit (e.g. 15 %) [10].25
Figure B.1 – Method A, telescopic method .43
Figure B.2 – Method B, near-range LUMINANCE meter in combination with an
ILLUMINANCE meter .44
Figure B.3 – Method C, frontal integrated LUMINANCE meter in combination with
ILLUMINANCE meter .44
Figure B.4 – Method D, back integrated LUMINANCE meter in combination with
ILLUMINANCE meter .45
Figure C.1 – Example of TG-18 QC pattern for a matrix size of 1536 × 2048.54
Table 1 – Overview to the definitions of physical parameters .10
Table 2 – TEST PATTERNS used for display testing .13
Table 3 – List of the evaluation methods that can be used for testing medical IMAGE
DISPLAY SYSTEMS .15
Table A.1 – Acceptance test sample report of a diagnostic display .29
Table A.2 – Constancy test sample report of a diagnostic display .33
Table A.3 – Acceptance test sample report of a monochrome reviewing display .35
Table A.4 – Constancy test sample report of a monochrome reviewing display .37
Table A.5 – Acceptance test sample report of a colour reviewing display .39
Table A.6 – Constancy test sample report of a colour reviewing display.41
Table C.1 – Description of multi-purpose TEST PATTERNS.47
Table C.2 – TG18-QC pattern: LUMINANCE levels with 8-bit and [12-bit] pixel values
and CX ratings.50
Table C.3 – The blurring characteristics of the CX reference set utilized in TG18-QC
TEST PATTERNS [16] .51
Table C.4 – Evaluation criteria for the examples of the CLINICAL REFERENCE IMAGES .52
Table C.5 – Example description of TG-18 QC pattern for a matrix size of 1536 × 2048 .53
– 4 – 62563-1 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –
Part 1: Evaluation methods
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 62563-1 has been prepared by subcommittee 62B: Diagnostic
imaging equipment of technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
Enquiry draft Report on voting
62B/743/CDV 62B/768/RVC
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:
62563-1 © IEC:2009 – 5 –
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THIS INTERNATIONAL STANDARD, OR AS NOTED: SMALL
CAPITALS.
A list of all parts of the IEC 62563 series, published under the general title Medical electrical
equipment – Medical image display systems, can be found on the IEC website.
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.
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.
– 6 – 62563-1 © IEC:2009
INTRODUCTION
This International Standard provides evaluation methods for testing IMAGE DISPLAY SYSTEMS
used in MEDICAL ELECTRICAL EQUIPMENT and medical electrical systems for diagnostic imaging.
On site or after installation, two types of testing can be carried out. An acceptance test is
carried out after a new IMAGE DISPLAY SYSTEM has been installed, or major modifications have
been made to the existing IMAGE DISPLAY SYSTEM. Since an IMAGE DISPLAY SYSTEM may
degrade over time, the constancy test is carried out by the user in a periodic cycle to verify
that the performance is maintained for the intended use.
The standard describes various evaluation methods without dictating what particular tests
shall be used for acceptance and/or constancy tests.
Rather, it is the intention of this standard to be a reference for other standards and guidelines
specific to each modality or to be defined by national authorities who will refer to the
evaluation methods of this standard and mention limiting values and frequencies for
acceptance and constancy tests. Annex A shows sample reports of such a reference.
To maintain the homogeneity in the IEC standards for MEDICAL ELECTRICAL EQUIPMENT,
IEC 61223-2-5, Evaluation and routine testing in medical imaging departments – Part 2-5:
Constancy tests – Image display devices should be reviewed.
62563-1 © IEC:2009 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –
Part 1: Evaluation methods
1 Scope
This part of IEC 62563 describes the evaluation methods for testing medical IMAGE DISPLAY
SYSTEMS.
The scope of this International Standard is directed to practical tests that can be visually
evaluated or measured using basic test equipment. More advanced or more quantitative
measurements can be performed on these devices, but these are beyond the scope of this
document.
This standard applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome
IMAGE DISPLAY
image information in the form of greyscale values on colour and greyscale
SYSTEMS (e.g. CATHODE RAY TUBE (CRT) monitors, FLAT PANEL DISPLAYS, PROJECTION SYSTEM).
This standard applies to medical IMAGE DISPLAY SYSTEMS used for diagnostic (interpretation of
medical images toward rendering clinical diagnosis) or viewing (viewing medical images for
medical purposes other than for providing a medical interpretation) purposes and therefore
having specific requirements in terms of image quality. Head mounted IMAGE DISPLAY SYSTEMS
IMAGE DISPLAY SYSTEMS used for confirming positioning and for operation of the system
and
are not covered by this standard.
It is not in the scope of this standard to define the requirements of acceptance and constancy
tests nor the frequencies of constancy tests.
2 Normative references
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.
IEC 60788:2004, Medical electrical equipment – Glossary of defined terms
ISO 11664-1:2007, Colorimetry – Part 1: CIE standard colorimetric observers
CIE S 010/E:2004 Photometry – The CIE system of physical photometry
3 Terms, definitions, symbols and abbreviations
3.1 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60788:2004 and the
following apply.
3.1.1
accuracy
closeness of agreement between a test result and the accepted reference value
[ISO 5725-1:1994, definition 3.6]
– 8 – 62563-1 © IEC:2009
3.1.2
brightness
LUMINANCE as perceived by the human visual system
3.1.3
cathode ray tube
CRT
picture tube
component of an IMAGE DISPLAY SYSTEM in which images defined via electrical signals are
visualized by means of an electron beam striking a phosphor
3.1.4
clinical reference image
specific medical image typical for the intended use of the IMAGE DISPLAY SYSTEM
NOTE The anatomical patterns reported in Annex C are examples of CLINICAL REFERENCE IMAGE.
3.1.5
clock artefact
artefact in form of distorted vertical bars or stripes, visible on the screens of fixed-pixel type
IMAGE DISPLAY DEVICES (e.g. LCD), when the frequency of the internal dot clock is different
from that of the incoming analogue signal
3.1.6
contrast
ratio of the difference of the LUMINANCE of two image areas, L - L ,
1 2
divided by the average of the two LUMINANCE values:
.
CONTRAST = 2 (L - L )/(L + L )
1 2 1 2
3.1.7
digital driving level
DDL
digital value given as input to an IMAGE DISPLAY SYSTEM producing a LUMINANCE
3.1.8
display controller
electronic component of an IMAGE DISPLAY SYSTEM that provides the analogue or digital
interface between the computer hardware and the IMAGE DISPLAY DEVICE
3.1.9
flat panel display
IMAGE DISPLAY DEVICE that is flat and thin
NOTE E.g. liquid crystal display (LCD), plasma display (PDP), field emission display (FED), surface-conduction
electron-emitter display (SED), carbon-nano-tube display (CNT), organic light-emitting display (OLED).
3.1.10
flicker
perception of unintentional fluctuations of the LUMINANCE over time
3.1.11
greyscale standard display function
GSDF
mathematically defined mapping of input, DIGITAL DRIVING LEVEL (DDL) to LUMINANCE values
based on the Barten model
62563-1 © IEC:2009 – 9 –
1)
[Source: DICOM PS 3.14:2007, see [2 ] ]
3.1.12
illuminance
measurement of the luminous flux incident on a surface per unit area (unit: Lux (lx),
lx = lm/m )
3.1.13
image display device
monitor
specific hardware/medium used to display images presented through an analogue or digital
interface
3.1.14
image display system
workstation consisting of an IMAGE DISPLAY DEVICE, DISPLAY CONTROLLER and computer
hardware and software, capable of displaying images
3.1.15
luminance
ratio of luminous flux penetrating (impinging on) a surface area in a specified direction to the
product of the irradiated solid angle and the projection of the surface area onto a plane
perpendicular to the viewing direction (unit: candela per square meter (cd/m ))
NOTE This definition has been derived from the term in DIN 5031-3:1982-03 [18] and is equivalent to the
definition in the International Electrotechnical Vocabulary (IEV).
3.1.16
phase artefact
artefact in form of blurred edges of displayed objects (letters, lines, etc.), visible on the
screens of fixed-pixel type IMAGE DISPLAY DEVICES (e.g. LCD), when the phase setting of the
internal dot clock is different from that of the incoming analogue signal
3.1.17
precision
closeness of agreement between independent test results obtained under stipulated
conditions
[ISO 5725-1:1994, definition 3.12]
3.1.18
projection system
large-screen IMAGE DISPLAY DEVICE which enlarges the small image generated on a plane by
central projection to a second plane
3.1.19
resolution addressability ratio
RAR
measured pixel at 50 % point of LUMINANCE at peak or nominal rating expressed as a
percentage of addressable space available
3.1.20
spatial resolution
measure of the ability of an IMAGE DISPLAY SYSTEM to distinguish spatial features of interest
within an image
—————————
1)
Figures in square brackets refer to the Bibliography.
– 10 – 62563-1 © IEC:2009
NOTE Systems designed with adequate SPATIAL RESOLUTION characteristics are necessary to assure that spatial
details of interest are preserved when a medical image is displayed. Portraying image data on a IMAGE DISPLAY
DEVICE with insufficient resolution will compromise the ACCURACY of the radiological interpretation.
3.1.21
test image
test pattern
image for testing or verifying the IMAGE DISPLAY SYSTEMS
3.1.22
veiling glare
enhancement of the LUMINANCE measurable on the IMAGE DISPLAY DEVICE caused by internal
scatter processes
NOTE The value of the LUMINANCE enhancement is dependent on the illuminated portion of the image displayed.
3.1.23
window setting
display of a subset of the pixel values existing in the digital image
NOTE The WINDOW SETTING is determined by the window width and level (centre) and serves for CONTRAST
enhancement.
3.2 Symbols
The symbols of physical parameters used in this standard are listed in Table 1. All
IMAGE DISPLAY DEVICE. Note that
measurements referred to in Table 1 are in the centre of the
LUMINANCE may also be measured at other locations according to the methodologies
described in this document.
Table 1 – Overview to the definitions of physical parameters
Abbreviation Mathematically derived Definition and explanation
L LUMINANCE generated by the ambient light on the surface of an
amb
IMAGE DISPLAY DEVICE when the IMAGE DISPLAY DEVICE is off.
L Minimum LUMINANCE generated by a IMAGE DISPLAY DEVICE at
min
DIGITAL DRIVING LEVEL (DDL) = 0 measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used for
measurement. It is measured with ambient light totally switched off
(in the dark).
L Maximum LUMINANCE generated by a IMAGE DISPLAY DEVICE at
max
DIGITAL DRIVING LEVEL (DDL) = max measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used for
measurement. It is measured with ambient light totally switched off
(in the dark).
L′ L + L LUMINANCE that will be perceived by the human eye at the centre of
min min amb
the screen at DIGITAL DRIVING LEVEL (DDL) = 0. It contains VEILING
GLARE and L
amb
L + L LUMINANCE produced by the IMAGE DISPLAY DEVICE at the maximum
L′
max amb
max
DIGITAL DRIVING LEVEL (DDL) measured at the centre of the screen.
It contains VEILING GLARE and L
amb.
R Diffuse reflection coefficient (provided by manufacturer with a
d
specific measurement method, ideally following the methods
described in Reference [10] using a CIE standard illuminant A and
an aperture size 20 to 30 % larger than the diameter of the
LUMINANCE meter).
r' LUMINANCE ratio of an IMAGE DISPLAY DEVICE containing VEILING
L′ /L′
max min
GLARE and ambient LUMINANCE.
E ILLUMINANCE.
a L /L′ Safety factor.
amb min
2 2 1/2
Δu'v' ((u ’-u ’) + (v ’-v ’) ) Maximum distance in u'-v' space.
1 2 1 2
62563-1 © IEC:2009 – 11 –
3.3 Abbreviations
The following abbreviations are used in this standard.
CRT cathode ray tube
CT computed tomography
DDL digital driving level
DICOM digital imaging and communication in medicine
LCD liquid crystal display
MR magnetic resonance
4 General
In IMAGE DISPLAY SYSTEMS, every individual component can limit or reduce the image quality of
the system. Therefore it is necessary to adopt suitable measures for quality monitoring. If
IMAGE DISPLAY SYSTEMS are correctly adjusted and maintained, these devices can consistently
generate similar images.
Simple test equipment is used (LUMINANCE meter, TEST IMAGES) with PRECISION appropriate for
the purpose of a test. Before a test, all test equipment shall be checked for its functioning
according to the manufacturer’s specifications.
The manufacturer's data (e.g. requirements on operating voltage, humidity etc.) are required
for the correct setting of the IMAGE DISPLAY SYSTEM and for correct installation. The
manufacturer's data shall be enclosed with the technical documentation of the IMAGE DISPLAY
SYSTEM.
The tests listed in this International Standard are a compilation of all the evaluation methods
that may be used for testing an IMAGE DISPLAY SYSTEM. A subset of these test items or test
methods may be selected and applied in any order depending on the intended purpose of the
IMAGE DISPLAY SYSTEM.
For mobile systems, a fixed location for these tests shall be determined and used so that it is
representative for the locations where such mobile systems may be used. Care should be
taken to ensure that the ambient lighting in these areas can be adequately controlled.
5 Prerequisites
Prior to testing an IMAGE DISPLAY SYSTEM, the following shall be considered:
a) The testing of an IMAGE DISPLAY SYSTEM shall include the complete system including
software, hardware and settings involved in image handling.
b) For all IMAGE DISPLAY SYSTEMS to be tested, all components including computer, IMAGE
DISPLAY DEVICE, display card, display software, and software version shall be traceable.
TEST IMAGES and the clinical images shall be presented in the same way on the IMAGE
c) The
DISPLAY SYSTEM.
d) Before starting the tests, the front surface of the IMAGE DISPLAY DEVICE shall be cleaned
according to the instructions for use.
e) It shall be ensured that no prior nominal settings have been changed.
f) Room lights, windows, viewing devices etc. shall not cause any disturbing reflections on
IMAGE DISPLAY DEVICE. Methods to prevent reflections are described in the standards
the
ISO 9241-302, ISO 9241-303, ISO 9241-305 and ISO 9241-307.
g) The ambient lighting in the room shall be maintained at normally used conditions.
– 12 – 62563-1 © IEC:2009
h) Before initiating a test, the IMAGE DISPLAY SYSTEM shall be installed and started up
according to the manufacturer’s recommendations; to ensure stable performance, the
IMAGE DISPLAY DEVICE shall be switched on before the test for a period as specified by the
manufacturer (e.g. 30 min). The IMAGE DISPLAY SYSTEM should be set to the desired display
function. The GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) is recommended and is a
necessary prerequisite for some tests.
6 Equipment and tools
6.1 LUMINANCE meter
A LUMINANCE meter shall have the following specifications. The range of the LUMINANCE meter
shall cover at least the range of LUMINANCE of the IMAGE DISPLAY SYSTEM with a PRECISION of at
most 5 % (repeatability), and an ACCURACY of at most 10 %, with a calibration traceable to a
primary standards laboratory. The manufacturer of the meter shall provide a clear calibration
program. The aperture angle shall not exceed 5°. The relative spectral sensitivity shall
correspond to the BRIGHTNESS CIE standard photopic spectral response (CIE S 010/E:2004).
The influence of the photopic response shall be within the overall ±10 % ACCURACY described
in this paragraph.
For near range LUMINANCE meters, a predefined angle and distance of measurement result in
a defined measurement field size. During a measurement, the area to be measured shall be
displayed by a field (or patch) that is significantly bigger than the defined measurement field
size.
A LUMINANCE meter can be integrated into the IMAGE DISPLAY SYSTEM or be a stand-alone
device.
6.2 ILLUMINANCE meter
An ILLUMINANCE meter may be required for testing IMAGE DISPLAY SYSTEMS with a range of 1 to
1 000 lux with an ACCURACY of at most 10 % and a PRECISION of at most 5 % (repeatability).
The device calibration shall be traceable to a primary standards laboratory and shall have a
clear calibration program. It shall have a uniform response to a Lambertian light source.
In measurement method B, C and D (described in A nne x B ) , the ILLUMINANCE meter is ideally
located at the centre of the screen facing outward. Side locations will also be acceptable as
long as they provide similar measured values.
6.3 Colour meter
A colour meter may be required for testing IMAGE DISPLAY SYSTEMS. The meter shall be able to
evaluate the CIE-specified (ISO11664-1:2007) colour coordinate with better than ±0,004
ACCURACY in the u’,v’ space (0,007 in the x,y space) for a standard illuminant, within the
LUMINANCE range of the IMAGE DISPLAY SYSTEM. The device calibration shall be traceable to a
primary measurement standard and shall have a clear calibration program.
62563-1 © IEC:2009 – 13 –
6.4 TEST PATTERNS
Table 2 – TEST PATTERNS used for display testing
TG18-QC for overall
testing CATHODE RAY TUBE
OIQ for overall testing
(CRT and LCD)
TG18-MP for LUMINANCE TG18-LN8-01 for
(LCD)
resolution
LUMINANCE
TG18-LN8-18 for TG18-UN10 for LUMINANCE TG18-UN80 for LUMINANCE TG18-CT for LUMINANCE
LUMINANCE uniformity uniformity response
ANG for angular response GD for geometrical TG18-UNL80 for TG18-GVN for VEILING
properties LUMINANCE uniformity GLARE
TG18-GV for VEILING GLARE
TG18-CH as example TG18-KN as example TG18-MM1 as example
mammogram
chest radiograph extremity radiograph
– 14 – 62563-1 © IEC:2009
TG18-MM2 as example BN01 for LUMINANCE (LCD) BN18 for LUMINANCE (LCD)
mammogram
A subset of these examples or elements from these examples may be used to form composite
TEST PATTERNS depending on the intended use of each modality being tested (see A n nex C f o r
more information).
7 Evaluation methods
7.1 General
This clause describes a number of evaluation methods (tests) that can be used for testing
medical IMAGE DISPLAY SYSTEMS. The number and order of these evaluation methods are not
mandatory; a modality standard can refer to a subset of these tests in any order with a
preference for limiting values and evaluation criteria.
7.2 Evaluation method table overview
Table 3 shows an overview of all evaluation methods described in this standard. Not all of
these tests may be required or be appropriate for a specific IMAGE DISPLAY SYSTEM. A subset
of test items or test methods to be performed can be chosen from these lists that are relevant
to a particular IMAGE DISPLAY SYSTEM. These tests can be performed in any appropriate order.
62563-1 © IEC:2009 – 15 –
Table 3 – List of the evaluation methods that can be used
for testing medical IMAGE DISPLAY SYSTEMS
Evaluation method Equipment, tools
Visual evaluation methods
Overall image quality evaluation TG18-QC TEST PATTERN
– Verify overall performance.
Greyscale resolution evaluation TG18-MP TEST PATTERN
– Verify sufficient greyscale resolution based on 8-
and 10-bit markers
LUMINANCE response evaluation (more complete TG18-CT TEST PATTERN
solution than overall image quality evaluation)
LUMINANCE uniformity evaluation TG18-UN80 TEST PATTERN
– Look for non-uniformities
Chromaticity evaluation TG18-UN80 TEST PATTERN
– Verify colour uniformity
Pixel faults evaluation TG18-UN10 and TG18-UN80 TEST PATTERN
– Look for dark (TG18-UN80) and bright (TG18-UN10)
pixel defects
VEILING GLARE evaluation TG18-GVN and TG18-GV TEST PATTERN, mask
– Look for low CONTRAST objects on 2 TEST PATTERNS
Geometrical image evaluation GD TEST PATTERN, ruler (CATHODE RAY TUBE (CRT) only)
– Verify geometry, phase/clock correction, clipping
Angular viewing evaluation ANG TEST PATTERN
– Verify viewing angle
Clinical evaluation Clinical TEST PATTERNS (examples see TG18-CH, TG18-
KN, TG18-MM1 and TG18-MM2)
Quantitative evaluation methods
Basic LUMINANCE evaluation LUMINANCE meter, ILLUMINANCE meter
Basic LUMINANCE evaluation without ambient light LUMINANCE meter
LUMINANCE response evaluation LUMINANCE meter, ILLUMINANCE meter
The GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) is
prerequisite for this test
LUMINANCE evaluation of multiple displays LUMINANCE meter
Chromaticity evaluation Colour meter
Chromaticity evaluation of multiple displays Colour meter
LUMINANCE uniformity evaluation LUMINANCE meter
Viewing angle evaluation (Provided by manufacturer)
– 16 – 62563-1 © IEC:2009
7.3 Visual evaluation methods
7.3.1 General
All visual tests shall be performed from the customary viewing distance unless specified
differently.
7.3.2 Overall image quality evaluation
The elements in the TG18-QC TEST IMAGE may be used to assess the overall performance of
IMAGE DISPLAY SYSTEMS as described in Figure 1.
Evaluate black-to-
white and white-to-
black transitions
Evaluate the appearance of
Evaluate the
the high CONTRAST line-pair
continuous
patterns at the centre and
appearance of
the four corners of the
ramp bars
pattern (the use of the low
CONTRAST patterns is
optional)
Evaluate the
appearance of all
16 LUMINANCE
patches
Evaluate the
appearance of the
5 % and 95 %
patches
Evaluate the
Evaluate the appearance of the
appearance of the low borders and lines
contrast letters (straight) of the
("quality control") in pattern and the
the 3 areas centring of the
pattern in the active
area of the IMAGE
DISPLAY DEVICE
IEC 2493/09
Figure 1 – Overall image quality evaluation using the TG18-QC TEST PATTERN
For CATHODE RAY TUBES (CRT) the SPATIAL RESOLUTION shall be included: Evaluate the CX
patterns at the centre and corners of the pattern and grade them compared to the reference
score (see A n nex C) .
As an alternative, the OIQ (overall image quality) TEST IMAGE may be used to assess overall
performance of LCDs as described in Figure 2.
62563-1 © IEC:2009 – 17 –
Evaluate black-to-
white and white-to-
black transitions
Evaluate the appearance of
the high CONTRAST line-pair
Evaluate the
patterns at the centre and
continuous
the four corners of the
appearance of
pattern (the use of the low
ramp bars
CONTRAST patterns is
optional)
Evaluate the
appearance of all
16 LUMINANCE
patches
Evaluate the
appearance of the
5 % and 95 %
patches
Evaluate the
Evaluate the appearance of the
appearance of the low borders and lines
contrast letters (straight) of the pattern
("quality control") in and the centring of the
the 3 areas pattern in THE ACTIVE
AREA OF THE IMAGE
DISPLAY DEVICE
IEC 2494/09
TEST PATTERN
Figure 2 – Overall image quality evaluation using the TG18-OIQ
During this test, also evaluate the overall appearance of the TEST PATTERN. Look for sufficient
SPATIAL RESOLUTION details, possible FLICKER, cross-talk, noise and video artefacts. Note that
a TEST PATTERN specifically designed to evaluate each of these items may also be used.
For the overall image quality evaluation the SMPTE TEST PATTERN can also be used with
similar criteria.
NOTE While not yet considered to be crucial for general display performance characteristics of medical displays,
dynamic display performance (also called temporal response) might be important for certain medical applications.
Other relevant documents may be consulted for applicable procedures to test the dynamic performance of medical
displays [1 5 ].
7.3.3 Greyscale resolution evaluation
The greyscale resolution of the IMAGE DISPLAY DEVICE shall be evaluated using the TG18-MP
TEST PATTERN as described in Figure 3. It might be good to magnify the pattern about 200 %
when doing the test.
– 18 – 62563-1 © IEC:2009
Carefully scan the vertical ramps for any
sign of horizontal contouring lines and
their relative locations. If such lines are
present, their location relative to 8-bit
These arrows point to 8-
bit t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...