SIST EN IEC 62563-2:2022

SLOVENSKI STANDARD
SIST EN IEC 62563-2:2022
01-februar-2022
Medicinska električna oprema - Sistemi za prikazovanje medicinskih slik - 2. del:
Preskusi sprejemljivosti in konstantnosti za prikazovanje medicinskih slik (IEC
62563-2:2021)
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and
constancy tests for medical image displays (IEC 62563-2:2021)
Medizinische elektrische Geräte - Medizinische Bildschirmsysteme - Akzeptanz- und
Konstanzprüfungen (IEC 62563-2:2021)
Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 2 : Essais
d’acceptation et de constance des systèmes d’imagerie médicale (IEC 62563-2:2021)
Ta slovenski standard je istoveten z: EN IEC 62563-2:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 62563-2:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 62563-2:2022


EUROPEAN STANDARD EN IEC 62563-2

NORME EUROPÉENNE

EUROPÄISCHE NORM December 2021
ICS 11.040.55; 31.120

English Version
Medical electrical equipment - Medical image display systems -
Part 2: Acceptance and constancy tests for medical image
displays
(IEC 62563-2:2021)
Appareils électromédicaux - Systèmes d'imagerie médicale Medizinische elektrische Geräte - Medizinische
- Partie 2 : Essais d'acceptation et de constance des Bildschirmsysteme - Akzeptanz- und Konstanzprüfungen
systèmes d'imagerie médicale (IEC 62563-2:2021)
(IEC 62563-2:2021)
This European Standard was approved by CENELEC on 2021-12-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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 IEC 62563-2:2021 E

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EN IEC 62563-2:2021 (E)
European foreword
The text of document 62B/1254/FDIS, future edition 1 of IEC 62563-2, 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 IEC 62563-2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–09–15
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–12–15
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 62563-2:2021 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
ISO/CIE 11664-1:2019 NOTE Harmonized as EN ISO/CIE 11664-1:2019 (not modified)
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified) +A11:2011
2

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EN IEC 62563-2:2021 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 62563-1 2009 Medical electrical equipment - Medical EN 62563-1 2010
image display systems - Part 1: Evaluation
methods
/AMD1 2016  /A1 2016


3

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IEC 62563-2

®


Edition 1.0 2021-11




INTERNATIONAL



STANDARD




NORME


INTERNATIONALE











Medical electrical equipment – Medical image display systems –

Part 2: Acceptance and constancy tests for medical image displays



Appareils électromédicaux – Systèmes d’imagerie médicale –

Partie 2: Essais d’acceptation et de constance des systèmes d’imagerie

médicale















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.55; 31.120 ISBN 978-2-8322-1039-8




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms, definitions, symbols and abbreviated terms . 7
3.1 Terms and definitions . 7
3.2 Symbols . 8
3.3 Abbreviated terms . 9
4 General . 9
5 Categories . 10
6 ACCEPTANCE TEST . 11
6.1 General . 11
6.2 When to test . 11
6.3 Evaluation items and CRITERIA for ACCEPTANCE TEST . 11
6.4 ACCEPTANCE TEST result . 15
7 CONSTANCY TEST . 16
7.1 General . 16
7.2 Frequency of CONSTANCY TEST . 16
7.3 Evaluation items and CRITERIA . 16
7.4 CONSTANCY TEST result . 16
Annex A (informative) Sample test reports . 17
A.1 General . 17
A.2 ACCEPTANCE TEST sample report of a category I-A diagnostic display . 17
A.2.1 General information . 17
A.2.2 Displays . 17
A.2.3 Test results. 17
A.3 CONSTANCY TEST sample report of a category I-A diagnostic display . 21
A.3.1 General information . 21
A.3.2 Displays . 21
A.3.3 Test results. 21
Annex B (informative) Ambient light control . 24
Annex C (informative) Evaluation CRITERIA examples of clinical images . 29
C.1 General . 29
C.2 Chest image . 29
Bibliography . 34
Index of defined terms . 35

Figure B.1 – L and E relationship when r' ≥ 250 . 24
min
Figure B.2 – Possible deviation range of E conforming to GSDF ±10 % . 26
Figure B.3 (1 of 2) – Example charts of possible deviation ranges of ILLUMINANCE (E),
calibrated at four different ambient LUMINANCE (L ) levels (shown at right) . 27
amb
Figure B.3 (2 of 2) – Example charts of possible deviation ranges of ILLUMINANCE (E),
calibrated at four different ambient LUMINANCE (L ) levels (shown at right) . 28
amb
Figure C.1 – Chest clinical image . 29

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Figure C.2 – Visually sharp reproduction of the vessel from hilum to peripheral area . 30
Figure C.3 – Visibility of vessels under retro-cardiac area and under diaphragm . 30
Figure C.4 – Visually sharp reproduction of trachea and proximal bronchia . 31
Figure C.5 – Distinct reproduction of frame of spine, lateral protrusion, and spinous
process . 31
Figure C.6 – Distinct reproduction of edge of heart . 31
Figure C.7 – Excellent graininess (no artefacts or significant noise) of thorax and

underarm soft tissue . 32
Figure C.8 – Distinct reproduction of the border of rib and peripheral lung, border of
lower edge of lung . 33

Table 1 – Overview to the definitions of physical parameters . 8
Table 2 – Tests and TEST ITEMs for quantitative evaluation . 11
Table 3 – Tests and TEST ITEMs for visual evaluation . 13
Table 4 – Quantitative acceptance and CONSTANCY TESTs . 14
Table 5 – Visual acceptance and CONSTANCY TESTs . 15

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –

Part 2: Acceptance and constancy tests
for medical image displays

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 IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 62563-2 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this International Standard is based on the following documents:
Draft Report on voting
62B/1254/FDIS 62B/1262/RVD

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 International Standard is English.

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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.
In this document, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THIS INTERNATIONAL STANDARD, OR AS NOTED: SMALL CAPITALS.
A list of all parts in the IEC 62563 series, published under the general title Medical electrical
equipment – Medical image display systems, can be found on the IEC website.
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.

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INTRODUCTION
This document defines ACCEPTANCE and CONSTANCY TESTS for medical image displays. It defines
TEST ITEMS for the ACCEPTANCE and CONSTANCY TESTS, as well as the performance CRITERIA and
the test frequency for each TEST ITEM, elements of the measurement method related to an image
quality parameter in an IMAGE DISPLAY SYSTEM. The evaluation methods of the TEST ITEMS are
not described in this document; rather, evaluation methods, along with prerequisites, equipment
and tools for the TEST ITEMS, are defined in IEC 62563-1.
ACCEPTANCE and CONSTANCY TESTS are performed on site at the installation facility. An
ACCEPTANCE TEST is carried out after a new IMAGE DISPLAY SYSTEM has been installed or major
modifications have been made to the existing IMAGE DISPLAY SYSTEM. Since an IMAGE DISPLAY
SYSTEM can degrade over time, CONSTANCY TESTS are carried out periodically to verify that the
performance is maintained.
This document describes appropriate TEST ITEMS and CRITERIA that are considered appropriate
as an international standard based on survey of quality control testing standards and guidelines
across the world. Although other existing standards and guidelines have been defined by other
standard organizations and can be given priority over this document, national authorities are
encouraged to adopt or harmonize to this document.

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MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –

Part 2: Acceptance and constancy tests
for medical image displays



1 Scope
This part of IEC 62563 establishes the performance CRITERIA and test frequencies for the
ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1.
The scope of this document is directed to practical tests that can be visually evaluated or
measured using basic test equipment. This document 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. This document does not apply to information displays and to
displays used solely for control of technical settings of all medical information.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 62563-1:2009, Medical electrical equipment – Medical image display systems – Part 1:
Evaluation methods
IEC 62563-1:2009/AMD1:2016
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions in IEC TR 60788:2004,
IEC 62563-1:2009/AMD1:2016 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1.1
ACCEPTANCE TEST
test carried out after equipment has been installed or major modifications have been made to
existing equipment to verify compliance with manufacturer's specifications or requirements
3.1.2
CONSTANCY TEST
test carried out to confirm that the functional performance of equipment meets established
CRITERIA and to enable the early recognition of changes in the properties of components of the
equipment

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3.1.3
LUMINANCE STABILIZER
embedded functionality of IMAGE DISPLAY SYSTEM which detects LUMINANCE deviation of light
source by sensor (e.g. at bootup, degradation over time, or temperature change) caused by the
IMAGE DISPLAY SYSTEM characteristics itself or its environments and adjusts light source
LUMINANCE
automatically to stabilize display
3.1.4
CRITERIA
acceptable deviation or limit defined for each test described in this document for the results of
an ACCEPTANCE or a CONSTANCY TEST which signal a conforming performance of the equipment
tested
3.1.5
TEST ITEM
element of the measurement method related to an image quality parameter in an IMAGE DISPLAY
SYSTEM
3.1.6
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a medical electrical (ME) equipment or a
medical electrical (ME) system
[SOURCE: IEC 60601-1:2005, 3.101]
3.2 Symbols
The symbols of physical parameters described in IEC 62563-1 are listed in Table 1. All
measurements referred to in Table 1 are in the centre of the IMAGE DISPLAY DEVICE; LUMINANCE
can also be measured at other locations according to the methodologies described in this
document.
Table 1 – Overview to the definitions of physical parameters
Symbol Mathematically derived Definition and explanation
L LUMINANCE generated by the ambient light on the surface of an
amb
IMAGE DISPLAY DEVICE when the IMAGE DISPLAY DEVICE is off.
L Minimum LUMINANCE generated by an IMAGE DISPLAY DEVICE at
min
DIGITAL DRIVING LEVEL (DDL) = 0 measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used
for measurement. It is measured with ambient light totally
switched off (ambient ILLUMINANCE lower than 5 lux at the face of
the IMAGE DISPLAY).
L Maximum LUMINANCE generated by an IMAGE DISPLAY DEVICE at
max
DIGITAL DRIVING LEVEL (DDL) = max. measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used
for measurement. It is measured with ambient light totally
switched off (ambient ILLUMINANCE lower than 5 lux at the face of
the IMAGE DISPLAY).
L′ L + L LUMINANCE that shall be perceived by the human eye at the
min min amb
centre of the screen at DIGITAL DRIVING LEVEL (DDL) = 0. It
contains VEILING GLARE and L .

amb
L + L LUMINANCE produced by the IMAGE DISPLAY DEVICE that shall be
L′
max amb
max
perceived by the human eye at the maximum DIGITAL DRIVING
LEVEL (DDL) measured at the centre of the screen. It contains
VEILING GLARE and L .
amb
L’ Target LUMINANCE at maximum DIGITAL DRIVING LEVEL (DDL) being
target
the IMAGE DISPLAY DEVICE vendor recommended value or the
value used during calibration (including the ambient light
contribution).

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Symbol Mathematically derived Definition and explanation
ΔL’ (L' – L' )/L' [%] Percentage of difference from L’ and measured actual L’
max max target target target max
at maximum DDL.
a L /L’ Safety factor
amb min
R Diffuse reflection coefficient (provided by manufacturer with a
d
specific measurement method, ideally following the methods
1
described in [1] using a CIE standard illuminant A and an
aperture size 20 % to 30 % larger than the diameter of the
LUMINANCE meter).
r' L′ /L′ LUMINANCE ratio of an IMAGE DISPLAY DEVICE containing VEILING
max min
GLARE and ambient LUMINANCE.
E ILLUMINANCE
2 2 1/2
Δu'v' Distance between two points (u ,v ) and (u ,v ) in u'-v' space.
((u ’-u ’) + (v ’-v ’) )
1 1 2 2
1 2 1 2

3.3 Abbreviated terms
CT computed tomography
DDL digital driving level
DICOM digital imaging and communication in medicine
GSDF greyscale standard display function
LCD liquid crystal display
MR magnetic resonance
QC quality control

4 General
In IMAGE DISPLAY SYSTEMS, every individual component can limit or reduce the image quality of
the system. Therefore, it is necessary to adopt suitable measures for quality monitoring. If IMAGE
DISPLAY SYSTEMS are correctly adjusted and maintained, these devices can consistently
generate similar images.
Simple test equipment is used (LUMINANCE meter, TEST IMAGES) with PRECISION appropriate for
a test. Before a test, all test equipment shall be checked for its functioning according to the
MAGE DISPLAY DEVICE should be placed in a likely clinical position
manufacturer’s specifications. I
while performing the measurements.
According to Clause 5, IMAGE DISPLAY DEVICES shall be categorized, and ACCEPTANCE TEST and
CONSTANCY TEST shall be performed respectively. ACCEPTANCE TEST shall be performed after a
new IMAGE DISPLAY SYSTEMS installation or major modification of an existing IMAGE DISPLAY
SYSTEM. The CONSTANCY TEST shall be performed periodically to confirm that the performance
is maintained.
The results of ACCEPTANCE and CONSTANCY TESTING shall be recorded. If the test did not meet
the CRITERIA, immediate response (e.g., as recommended by the IMAGE DISPLAY DEVICE
manufacturer) such as repair service, re-calibration, or replace of IMAGE DISPLAY DEVICE (s) shall
be performed. It is optimal to manage systems properly and not fail the tests. If tests fail,
analysis of results or more frequent testing is advisable. Testing conditions, test instruments,
TEST PATTERNS and evaluation methods are defined in IEC 62563-1. Annex A shows a sample
ACCEPTANCE and CONSTANCY TEST report.
___________
1
 Numbers in square brackets refer to the Bibliography.

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5 Categories
IMAGE DISPLAY DEVICES shall be categorized in three categories: I, II and III. Category I is further
categorized in 2 subcategories: I-A and I-B.
The following application categories and subcategories are defined.
Category I-A: IMAGE DISPLAY DEVICE which has at least a 2 048 × 2 048 pixel array size and
a GSDF LUMINANCE response. This category is recommended if consistent
visibility of subtle contrast and finest detail is required for accurate diagnosis.
Application examples include mammography and digital breast
tomosynthesis.

Category I-B: IMAGE DISPLAY DEVICE which has at least a 1 024 × 1 024 pixel array size and
a GSDF LUMINANCE response. This category is recommended if consistent
visibility of low contrast and fine detail is required for the clinical application.
Application examples include images such as chest X-ray, CT and MR, and
breast biopsy.
Category II: IMAGE DISPLAY DEVICE which has a GSDF LUMINANCE response. This category
is reco
...