IEC 62563-1:2009/AMD2:2021

IEC 62563-1 ®
Edition 1.0 2021-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils electromedicaux – Systemes d'imagerie medicale –
Partie 1: Méthodes d’évaluation

IEC 62563-1:2009-12/AMD2:2021-07(en-fr)

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IEC 62563-1 ®
Edition 1.0 2021-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
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 978-2-8322-9970-8

– 2 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT – MEDICAL IMAGE DISPLAY
SYSTEMS –
Part 1: Evaluation methods
AMENDMENT 2
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,
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interested IEC National Committees.
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9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
Draft Report on voting
62B/1168/CDV 62B/1203/RVC
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.

© IEC 2021
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 4 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
INTRODUCTION to Amendment 2
This amendment is intended to introduce evaluation methods for handheld display devices.
Add, after the existing Annex C, the following new Annex D:
Annex D
(informative)
Evaluation methods for handheld display devices
D.1 General
This annex describes the evaluation methods that apply to handheld display devices. Handheld
display devices are defined as portable (carry-along) image display devices that are typically
small and lightweight including smartphones and tablet and notebook computers not specifically
for medical use. Handheld devices are convenient, easy to access, and can be of use in
emergency situations (including for example natural disasters) and for remote consultation.
Current handheld viewing technologies with limited workspaces are unlikely to replace
dedicated medical IMAGE DISPLAY SYSTEMS in this document better suited for conventional
radiology workflow and standard primary reporting. However, mobile devices are enabling
timely patient management and collaboration in care. Clear procedures to promote improved
practices in the use of handhelds in emergency situations and for remote consultation are
required. The major characteristics of typical handheld device and IMAGE DISPLAY SYSTEMS as
defined in this document are listed in Table D.1.
Table D.1 – Major characteristics of typical handheld devices
compared to IMAGE DISPLAY SYSTEMS
Characteristics Handheld device Medical IMAGE DISPLAY
SYSTEM (for diagnosis)
Calibration of the LUMINANCE Unspecified or not possible DICOM GSDF
response
LUMINANCE stability Uncontrolled Controlled
Ambient illumination Variable and uncontrolled Fixed or controlled
Viewing angle and distance Variable and uncontrolled Fixed or limited
QC software None Available
D.2 TEST PATTERNS for handheld devices
Table D.2 shows the TEST PATTERNS for handheld devices. Handheld devices can differ from
medical IMAGE DISPLAY SYSTEMS in terms of resolution, aspect ratio and screen size. Therefore
simple TEST PATTERNS are required. The proposed TEST PATTERNS are described in Table D.4.

© IEC 2021
Table D.2 – TEST PATTERNS for handheld device

Hh-Rmp_1H: Hh-Rmp_1V: Hh-Rmp_3H: Hh-Rmp_3V:
Ramp delta 1 (horizontal) Ramp delta 1 (vertical) Ramp delta 3 (horizontal) Ramp delta 3 (vertical)

Hh-Ctr (Landscape):
Hh-Ctr (Portrait): Hh-SpR: Hh-ANG(64):
CONTRAST -4/+4
CONTRAST -4/+4 SPATIAL RESOLUTION Angular response (64)
(emphasized)
– 6 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
Hh-ANG(204): Hh-L01(0): Hh-L09(120): Hh-L18(255):
LUMINANCE response01(0) LUMINANCE LUMINANCE
Angular response(204)
response09(120) response18(255)
(emphasized)
Hh-UN10(26): Hh-UN80(204):
Uniformity-10(26) Uniformity-80(204)

D.3 Evaluation methods for handheld devices
D.3.1 General
To perform visual evaluation described in D.3.4 and quantitative evaluation described in D.3.5
by reference to D.3.2, appropriate TEST PATTERNS that have the same display resolutions of
handheld device under test shall be used. LUMINANCE response should be evaluated prior to
use by performing a visual greyscale test. LUMINANCE uniformity should be evaluated only for
handheld devices with 10 inches (25,4 cm) or larger screen size (diagonal). Prior to use,
CONTRAST should be evaluated using Hh-Ctr, and pixel resolution should be evaluated using
Hh-SpR TEST PATTERN.
D.3.2 Recommended TEST ITEMS
TEST ITEMS recommended are listed in Table D.3.

© IEC 2021
Table D.3 – Recommended TEST ITEMS for handheld devices

TEST ITEM Prior to use Acceptance and TEST PATTERN
constancy testing
Greyscale evaluation R HR Hh-Rmp_1H, 1V
Greyscale (CONTRAST) resolution R HR Hh-Rmp_3H, 3V
evaluation
CONTRAST evaluation HR HR Hh-Ctr
Pixel resolution evaluation HR HR Hh-SpR
Angular viewing evaluation R R Hh-ANG(64), (204)
LUMINANCE response test - HR Hh-L01(0)-L18(255)
LUMINANCE uniformity test - HR Hh-UN10(26),
(for devices larger UN80(204)
than 10 inches (25,4
cm) diagonal)
Key
HR Highly recommended
R Recommended
D.3.3 Conditions of viewing test
Evaluation should be conducted using actual use conditions either in portrait or landscape mode.
Scaling shall not be performed in TEST PATTERNS Hh-SpR, Hh-ANG(64), (204). If such TEST
PATTERNS are scaled up or down, it should be recognized due to the lack of one or more borders,
location of border, or unevenness of line spacing of Hh-SpR.
D.3.4 Visual evaluation method
D.3.4.1 Greyscale evaluation
Evaluate Hh-Rmp_1H, 1V TEST PATTERNS for continuous appearance of greyscale.
D.3.4.2 Greyscale (CONTRAST) resolution evaluation
Evaluate Hh-Rmp_3H, 3V TEST PATTERNS for appearance of greyscale steps of staircase.
D.3.4.3 CONTRAST evaluation
Evaluate Hh-Ctr TEST PATTERN for visibility of two rectangles inside each of the 52 rectangles.
The following diagram (Figure D.1) schematically shows the arrangement of the patches in the
Hh-Ctr TEST PATTERN. A full textual description of Hh-Ctr TEST PATTERNS is provided in Table
D.4.
Measurement Visual
– 8 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
Figure D.1 – Hh-Ctr TEST PATTERN
D.3.4.4 Pixel resolution evaluation
Evaluate the equal interval appearance of Hh-SpR TEST PATTERNS at 3on/3off, 2on/2off and
1on/1off each for horizontal and vertical respectively.
D.3.4.5 Angular viewing evaluation
Read the target in the centre of Hh-ANG(64), (204) TEST PATTERNS (Figure D.2) at perpendicular
viewing, and then determine the maximum angle in off-normal directions (for example, in the
horizontal and vertical directions) where the number of visible lines is not fewer compared to
the perpendicular viewing direction. Both numbers of lines are always between 0 and 10 as
shown in Figure D.2.
Figure D.2 – Grey level emphasized angular target

© IEC 2021
D.3.5 Quantitative evaluation methods
UMINANCE response test
D.3.5.1 L
Using a calibrated LUMINANCE meter and the Hh-L01(0)-L18(255) TEST PATTERNS, the LUMINANCE
DIGITAL DRIVING LEVEL (DDL) P-values, L(P), by
L in the test region shall be measured for all 18
the measurement methods in Annex B. Evaluate the plot appearance (by comparison with ideal
curve) and variation from last test.
D.3.5.2 LUMINANCE uniformity test
Measure the LUMINANCE at five locations on the faceplate of the handheld device (centre and
four corners) using the Hh-UN10(26), UN80(204) TEST PATTERNS and method A or B in Annex
B. The maximum LUMINANCE deviation is calculated as a percent difference between the highest
and lowest LUMINANCE values relative to their average value, 200 × (L - L / (L +
highest lowest) highest
).
Llowest
D.4 Description of TEST PATTERNS for handheld devices
The TEST PATTERN’s matrix size shall fit into the screen matrix size of the handheld device and
it is essential to make a one-on-one relationship between the image pixels and the display
pixels. Pixel dimensions, locations and pixel values of each feature are described in Table D.4.
The width of borders within patterns except for Hh-Ctr and Hh-UN10(26), UN80(204) are set to
0,5 % of the long side of the handheld device. The border is used to see if borders are on the
edges of the screen correctly or not, to make sure TEST PATTERNS are not scaled. The
parameters indicated in the Table D.4 show the number of pixels. For example the value of Hh-
Rmp_1H with a matrix size of 1 080 × 1 920 for handheld device. Short side: S = 1 080, Long
side: L = 1 920, Border: B = 10, Width of a ramp: NH=1 060, Width of a patch: PH=4 or 5.
Table D.4 – Description of TEST PATTERNS for handheld devices
TEST Pixel dimensions and location Pixel values
PATTERN/features 8-bit
Hh-Rmp_1H
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP (L × 0,5 %)
LUMINANCE ramp A LUMINANCE ramp is arranged to the right side from the left side in the 0, 1, …, 255
area except for border from background of a display. n=256
Ramp width
N = S - B × 2.
H
Width of a patch Width of a patch
P = N / 256
H H
Adjust the width as appropriate.
Hh-Rmp_1V
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP (L × 0,5 %)
LUMINANCE ramp A LUMINANCE ramp is arranged to the lower side from the upper side in 0, 1, …, 255
the area except for border from background of a display. n=256
Ramp width
N = L – B × 2
V
– 10 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
TEST Pixel dimensions and location Pixel values
PATTERN/features 8-bit
Width of a patch Width of a patch
P = N / 256
V V
Adjust the width as appropriate
Hh-Rmp_3H
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP(L × 0,5 %)
CONTRAST resolution A CONTRAST resolution pattern is arranged at equal intervals to the right 0, 3, …, 255
pattern side from the left side except for border from background of a display.
Pattern width
N = S – B × 2
H
Width of  Width of a patch
a patch P = N / 86
H H
Adjust the width as appropriate.
Hh-Rmp_3V
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP(L × 0,5 %)
CONTRAST resolution A CONTRAST resolution pattern is arranged at equal intervals to the 0, 3, …, 255
pattern lower side from the upper side except for border from background of a
display.
Pattern width
N = L – B × 2
V
Width of  Width of a patch
a patch P = N / 86
V V
Adjust the width as appropriate.
Hh-Ctr (Portrait)
Border Border thickness is at least 0,5 % of the long size of the pattern. If 0
needed, the thickness of the vertical borders shall be increased until
the width of the central area is a multiple of 4 pixels. If needed, the
thickness of the horizontal borders shall be increased until the height of
the central area is a multiple of 13 pixels.
Background 52 background rectangles are arranged in a grid of 4 columns and 13 0, 5, …, 255
rectangles rows. The first rectangle with pixel value 0 is located at the top left
position (0, 0) in the grid. The following rectangles are following
diagonal lines with the following positions (horizontal, vertical) in the
grid: (1,0), (0,1), (2,0), (1,1), (0,2), (3,0), (2,1), (1,2), (0,3), (3,1), (2,2),
(1,3), (0,4), (3, 2), …
Foreground Inside each background rectangle, two smaller foreground rectangles -4/+4
rectangles are present: one foreground rectangle (left) with pixel value
(background rectangle pixel value - 4) and one foreground rectangle
(right) with pixel value (background rectangle pixel value + 4). Inside
the first background rectangle, where the background pixel value is 0,
the left foreground rectangle has pixel value 0. Inside the last
background rectangle, where the background pixel value is 255, the
right foreground rectangle has pixel value 255. The two foreground
rectangles inside each background rectangle should be separated
vertically and horizontally from the border of the background rectangle,
and horizontally from each other, with a distance which is approximately
25 % of the height of the background rectangle.

© IEC 2021
TEST Pixel dimensions and location Pixel values
PATTERN/features 8-bit
Hh-Ctr (Landscape)
Border Border thickness is at least 0,5 % of the long size of the pattern. If 0
needed, the thickness of the horizontal borders shall be increased until
the width of the central area is a multiple of 4 pixels. If needed, the
thickness of the vertical borders shall be increased until the height of
the central area is a multiple of 13 pixels.
Background 52 background rectangles are arranged in a grid of 13 columns and 4 0, 5, …, 255
rectangles rows. The first rectangle with pixel value 0 is located at the top left
position (0, 0) in the grid. The following rectangles are following
diagonal lines with the following positions (horizontal, vertical) in the
grid: (1,0), (0,1), (2,0), (1,1), (0,2), (3,0), (2,1), (1,2), (0,3), (4,0), (3,1),
(2,2), (1,3), (5,0), …
Foreground Inside each background rectangle, two smaller foreground rectangles -4/+4
rectangles are present: one foreground rectangle (top) with pixel value
(background rectangle pixel value - 4) and one foreground rectangle
(bottom) with pixel value (background rectangle pixel value + 4). Inside
the first background rectangle, where the background pixel value is 0,
the top foreground rectangle has pixel value 0. Inside the last
background rectangle, where the background pixel value is 255, the
bottom foreground rectangle has pixel value 255. The two foreground
rectangles inside each background rectangle should be separated
vertically and horizontally from the border of the background rectangle,
and vertically from each other, with a distance which is approximately
25 % of the width of the background rectangle.
Hh-SpR
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP (L × 0,5 %)
– 12 – IEC 62563-1:2009/AMD2:2021
© IEC 2021
TEST Pixel dimensions and location Pixel values
PATTERN/features 8-bit
Line pairs The area except for border is divided in upper half containing five 0,255
groups of vertical line-pairs and lower half containing five groups of
(vertical and
horizontal line-pairs.
horizontal line-pair
groups) Vertical line-pair groups (3 on, 3 off), (2 on, 2 off), (1 on, 1 off), (2 on, 2
off), (3 on, 3 off) are arranged from the left.

Vertical line-pair (3 on, 3 off): 3 vertical lines off, 3 vertical lines
on …(repeat from left to right)
Vertical line-pair (2 on, 2 off): 2 vertical lines off, 2 vertical lines
on …(repeat from left to right)
Vertical line-pair (1 on, 1 off): 1 vertical line off, 1 vertical line
on …(repeat from left to right)

Width of vertical line-pair groups (3 on, 3 off) area W , vertical line-pair
groups (2 on, 2 off) area W , vertical line-pair groups (1 on, 1 off) area
W
W , W , W = ROUNDDOWN(S – B × 2) / 5.
3 2 1
Under the above conditions, the optimum values of W , W , and W are
1 2 3
obtained.
Horizontal line-pair groups (3 on, 3 off), (2 on, 2 off), (1 on, 1 off), (2
on, 2 off), (3 on, 3 off) are arranged from the left in half of lower part.

Horizontal line-pair (3 on, 3 off): 3 horizontal lines off, 3 horizontal lines
on …(repeat from top to bottom)
Horizontal line-pair (2 on, 2 off): 2 horizontal lines off, 2 horizontal lines
on …(repeat from top to bottom)
Horizontal line-pair (1 on, 1 off): 1 horizontal line off, 1 horizontal line
on …(repeat from top to bottom)

Width of each horizontal line-pair groups is the same as the width of
vertical line-pair group W , W , W .
3 2 1
The height H of each vertical line-pair group is equal.
L
H = ROUNDDOWN(L - B × 2) / 2
L
The height H of each horizontal line-pair group is equal.
D
H = (L - B × 2) - H
D L
Hh-ANG (64), Hh-ANG(204)
Background S × L 64 or 204
Border The width of the border (equal for both the long and the short side of 128
the display) is 0,5 % of the number of pixels in the long direction –
rounded up to the nearest integer value.
B = ROUNDUP (L × 0,5 %)
© IEC 2021
TEST P
...