IEC 62563-1:2009/AMD2:2021

Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

Amendement 2 - Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 1: Méthodes d'évaluation

General Information

• Status: Published
• Publication Date: 18-Jul-2021
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 51 - TC 62/SC 62B/WG 51
• Current Stage: PPUB - Publication issued
• Start Date: 03-Aug-2021
• Completion Date: 19-Jul-2021

Relations

• Amends: IEC 62563-1:2009 - 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 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)

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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always
committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 000 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 18 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc

If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: [e-mail].
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Recherche de publications IEC - IEC online collection - oc.iec.ch
webstore.iec.ch/advsearchform Découvrez notre puissant moteur de recherche et consultez
La recherche avancée permet de trouver des publications IEC gratuitement tous les aperçus des publications. Avec un
en utilisant différents critères (numéro de référence, texte, abonnement, vous aurez toujours accès à un contenu à jour
comité d’études, …). Elle donne aussi des informations sur adapté à vos besoins.
les projets et les publications remplacées ou retirées.

Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
Le premier dictionnaire d'électrotechnologie en ligne au
Restez informé sur les nouvelles publications IEC. Just
monde, avec plus de 22 000 articles terminologiques en
Published détaille les nouvelles publications parues.
anglais et en français, ainsi que les termes équivalents dans
Disponible en ligne et une fois par mois par email.
16 langues additionnelles. Egalement appelé Vocabulaire

Electrotechnique International (IEV) en ligne.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
[e-mail].
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
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 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)
...