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SLOVENSKI STANDARD
01-november-2021
Medicinska električna oprema - Sistemi za prikazovanje medicinskih slik - 1. del:
Metode vrednotenja - Dopolnilo A2 (IEC 62563-1:2009/AMD2:2021)
Medical electrical equipment - Medical image display systems - Part 1: Evaluation
methods (IEC 62563-1:2009/AMD2:2021)
Medizinische elektrische Geräte - Medizinische Bildwiedergabesysteme - Teil 1:
Bewertungsmethoden (IEC 62563-1:2009/AMD2:2021)
Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 1: Méthodes
d'évaluation (IEC 62563-1:2009/AMD2:2021)
Ta slovenski standard je istoveten z: EN 62563-1:2010/A2:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 62563-1:2010/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2021
ICS 11.040.55
English Version
Medical electrical equipment - Medical image display systems -
Part 1: Evaluation methods
(IEC 62563-1:2009/AMD2:2021)
Appareils électromédicaux - Systèmes d'imagerie médicale Medizinische elektrische Geräte - Medizinische
- Partie 1: Méthodes d'évaluation Bildwiedergabesysteme - Teil 1: Bewertungsmethoden
(IEC 62563-1:2009/AMD2:2021) (IEC 62563-1:2009/AMD2:2021)
This amendment A2 modifies the European Standard EN 62563-1:2010; it was approved by CENELEC on 2021-08-23. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62563-1:2010/A2:2021 E
European foreword
The text of document 62B/1168/CDV, future IEC 62563-1/AMD2, 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 approved by CENELEC as EN 62563-1:2010/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–05–23
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–08–23
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 62563-1:2009/AMD2:2021 was approved by CENELEC as
a European Standard without any modification.
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 62563-1:2009/AMD2:2021 – 3 –
© 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 /members_experts/refdocs. The main document types developed by IEC are
described in greater detail at /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 62563-1:2009/AMD2:2021 – 5 –
© 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 62563-1:2009/AMD2:2021 – 7 –
© 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,
locatio
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