IEC 62563-1:2009

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.

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.

General Information

• Status: Published
• Publication Date: 18-Jul-2021
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 36 - TC 62/SC 62B/WG 36
• Current Stage: PPUB - Publication issued
• Start Date: 15-Mar-2010
• Completion Date: 10-Dec-2009

Relations

• Amended By: IEC 62563-1:2009/AMD1:2016 - Amendment 1 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
• Effective Date: 05-Sep-2023
• Amended By: IEC 62563-1:2009/AMD2:2021 - Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
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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 978-2-88910-764-3
– 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-
...

IEC 62563-1 ®
Edition 1.1 2016-03
CONSOLIDATED VERSION
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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IEC 62563-1 ®
Edition 1.1 2016-03
CONSOLIDATED VERSION
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
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-3270-5

IEC 62563-1 ®
Edition 1.1 2016-03
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils électromédicaux – Systèmes d’imagerie médicale –
Partie 1: Méthodes d’évaluation

– 2 – IEC 62563-1:2009+AMD1:2016 CSV
 IEC 2016
CONTENTS
FOREWORD. 4
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 7
1 Scope . 8
2 Normative references . 8
3 Terms, definitions, symbols and abbreviations . 8
3.1 Terms and definitions . 8
3.2 Symbols . 11
3.3 Abbreviations . 12
4 General . 12
5 Prerequisites . 12
6 Equipment and tools . 13
6.1 LUMINANCE meter . 13
6.2 ILLUMINANCE meter . 13
6.3 Colour meter . 13
6.4 TEST PATTERNS . 14
7 Evaluation methods . 15
7.1 General . 15
7.2 Evaluation method table overview . 15
7.3 Visual evaluation methods . 17
7.3.1 General . 17
7.3.2 Overall image quality evaluation . 17
7.3.3 Greyscale resolution evaluation . 18
7.3.4 LUMINANCE response evaluation . 19
7.3.5 LUMINANCE uniformity evaluation . 20
7.3.6 Chromaticity evaluation . 20
7.3.7 Pixel faults evaluation . 20
7.3.8 VEILING GLARE evaluation . 21
7.3.9 Geometrical image evaluation . 21
7.3.10 Angular viewing evaluation . 22
7.3.11 Clinical evaluation . 23
7.4 Quantitative evaluation methods . 23
7.4.1 Basic LUMINANCE evaluation . 23
7.4.2 Basic LUMINANCE evaluation without ambient light . 24
7.4.3 LUMINANCE response evaluation . 24
7.4.4 LUMINANCE evaluation of multiple displays . 27
7.4.5 Chromaticity uniformity evaluation . 27
7.4.6 Chromaticity evaluation of across multiple displays . 27
7.4.7 LUMINANCE uniformity evaluation . 27
7.4.8 Viewing angle evaluation . 28
7.4.9 Greyscale chromaticity evaluation . 28
Annex A (informative) Sample test reports . 29
Annex B (informative) LUMINANCE measurement methods . 48
Annex C (informative) Description of TEST PATTERNS . 51
Bibliography . 60

 IEC 2016
Index of defined terms . 62

Figure 1 – Overall image quality evaluation using the TG18-QC TEST PATTERN . 17
Figure 2 – Overall image quality evaluation using the TG18-OIQ TEST PATTERN . 18
Figure 3 – Magnified view of TG18-MP TEST PATTERN showing the 8-bit and 10-bit
markers . 19
Figure 4 – A close-up of the TG18-CT TEST PATTERN . 20
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) . 21
Figure 6 – Geometrical evaluation using the GD pattern . 22
Figure 7 – Visual evaluation of viewing angle response . 23
Figure 8 – Example of the measured LUMINANCE in relation to the standard LUMINANCE
response function according to GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) . 26
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] . 26
Figure B.1 – Method A, telescopic method . 48
Figure B.2 – Method B, near-range LUMINANCE meter in combination with an
ILLUMINANCE meter . 49
Figure B.3 – Method C, frontal integrated LUMINANCE meter in combination with
ILLUMINANCE meter . 49
Figure B.4 – Method D, back integrated LUMINANCE meter in combination with
ILLUMINANCE meter . 50
Figure C.1 – Example of TG-18 QC patt
...

IEC 62563-1 ®
Edition 1.2 2021-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils electromedicaux – Systemes d'imagerie medicale –
Partie 1: Méthodes d’évaluation

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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IEC 62563-1 ®
Edition 1.2 2021-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils electromedicaux – Systemes d'imagerie medicale –
Partie 1: Méthodes d’évaluation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-5336-6

IEC 62563-1 ®
Edition 1.2 2021-07
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils electromedicaux – Systemes d'imagerie medicale –
Partie 1: Méthodes d’évaluation

– 2 – IEC 62563-1:2009+AMD1:2016
+AMD2:2021 CSV  IEC 2021
CONTENTS
FOREWORD. 5
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope . 8
2 Normative references . 8
3 Terms, definitions, symbols and abbreviations . 8
3.1 Terms and definitions . 8
3.2 Symbols . 11
3.3 Abbreviations . 12
4 General . 12
5 Prerequisites . 12
6 Equipment and tools . 13
6.1 LUMINANCE meter . 13
6.2 ILLUMINANCE meter . 13
6.3 Colour meter . 13
6.4 TEST PATTERNS . 14
7 Evaluation methods . 15
7.1 General . 15
7.2 Evaluation method table overview . 15
7.3 Visual evaluation methods . 17
7.3.1 General . 17
7.3.2 Overall image quality evaluation . 17
7.3.3 Greyscale resolution evaluation . 18
7.3.4 LUMINANCE response evaluation . 19
7.3.5 LUMINANCE uniformity evaluation . 20
7.3.6 Chromaticity evaluation . 20
7.3.7 Pixel faults evaluation . 20
7.3.8 VEILING GLARE evaluation . 21
7.3.9 Geometrical image evaluation . 21
7.3.10 Angular viewing evaluation . 22
7.3.11 Clinical evaluation . 23
7.4 Quantitative evaluation methods . 23
7.4.1 Basic LUMINANCE evaluation . 23
7.4.2 Basic LUMINANCE evaluation without ambient light . 24
7.4.3 LUMINANCE response evaluation . 24
7.4.4 LUMINANCE evaluation of multiple displays . 27
7.4.5 Chromaticity uniformity evaluation . 27
7.4.6 Chromaticity evaluation of across multiple displays . 27
7.4.7 LUMINANCE uniformity evaluation . 27
7.4.8 Viewing angle evaluation . 28
7.4.9 Greyscale chromaticity evaluation . 28
Annex A (informative) Sample test reports . 29
Annex B (informative) LUMINANCE measurement methods . 48
Annex C (informative) Description of TEST PATTERNS . 51

+AMD2:2021 CSV  IEC 2021
Annex D (informative)  Evaluation methods for handheld display devices . 60
Bibliography . 70
Index of defined terms . 72

Figure 1 – Overall image quality evaluation using the TG18-QC TEST PATTERN . 17
Figure 2 – Overall image quality evaluation using the TG18-OIQ TEST PATTERN . 18
Figure 3 – Magnified view of TG18-MP TEST PATTERN showing the 8-bit and 10-bit
markers . 19
Figure 4 – A close-up of the TG18-CT TEST PATTERN . 20
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) . 21
Figure 6 – Geometrical evaluation using the GD pattern . 22
Figure 7 – Visual evaluation of viewing angle response . 23
Figure 8 – Example of the measured LUMINANCE in relation to the standard LUMINANCE
response function according to GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) . 26
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] . 26
Figure B.1 – Method A, telescopic method . 48
Figure B.2 – Method B, near-range LUMINANCE meter in combination with an
ILLUMINANCE meter . 49
Figure B.3 – Method C, frontal integrated LUMINANCE meter in combination with
ILLUMINANCE meter . 49
Figure B.4 – Method D, back integrated LUMINANCE meter in combination with
ILLUMINANCE meter . 50
Figure C.1 – Example of TG-18 QC pattern for a matrix size of 1536 × 2048 . 59
Figure D.1 – Hh-Ctr TEST PATTERN . 64
Figure D.2 – Grey level emphasized angular target . 64

Table 1 – Overview to the definitions of physical parameters . 11
Table 2 – TEST PATTERNS used for display testing . 14
Table 3 – List of the evaluation meth
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