EN 62563-1:2010
(Main)Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
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
Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 1: Méthodes d'évaluation
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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2010
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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 – Ac
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