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,
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
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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
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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)
...