EN IEC 62563-2:2021
(Main)Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
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.
Medizinische elektrische Geräte - Medizinische Bildschirmsysteme - Akzeptanz- und Konstanzprüfungen
Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 2 : Essais d’acceptation et de constance des systèmes d’imagerie médicale
L'IEC 62563-2:2021 établit les CRITÈRES de performance et les fréquences d’essai pour les ESSAIS D’ACCEPTATION et les ESSAIS DE CONSTANCE. Les méthodes d’évaluation sont définies dans l’IEC 62563-1. Le présent document est destiné aux essais pratiques qui peuvent faire l’objet d’une évaluation ou d’un mesurage visuels en utilisant un matériel d’essai de base. Le présent document s’applique aux SYSTÈMES D’IMAGERIE médicale qui peuvent afficher des informations d’images monochromes sous forme de valeurs à échelle des gris sur les SYSTÈMES D’IMAGERIE à échelle des gris et couleur. Le présent document ne s’applique pas aux écrans d’affichage d’informations et aux écrans d’affichage utilisés uniquement pour le contrôle des configurations techniques de toutes les informations médicales.
Medicinska električna oprema - Sistemi za prikazovanje medicinskih slik - 2. del: Preskusi sprejemljivosti in konstantnosti za prikazovanje medicinskih slik (IEC 62563-2:2021)
Ta del standarda IEC 62563 določa KRITERIJE delovanja in preskusne frekvence za PREVZEMNE PREIZKUSE in PRESKUSE NESPREMENLJIVOSTI. Te metode ocenjevanja so določene v standardu IEC 62563-1. Področje uporabe tega dokumenta je namenjeno praktičnim preskusom, ki jih je mogoče vizualno oceniti ali izmeriti s pomočjo osnovne preskusne opreme. Ta dokument se navezuje na SISTEME ZA PRIKAZ MEDICINSKE SLIKE, ki lahko prikažejo informacije na enobarvnih slikah v obliki vrednosti sivin na barvnih in sivinskih SISTEMIH ZA PRIKAZ MEDICINSKE SLIKE. Ta dokument se ne uporablja za informacijske zaslone in zaslone, ki se uporabljajo izključno za nadzor tehničnih nastavitev vseh medicinskih informacij.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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
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
– 2 – IEC 62563-2:2021 © IEC:2021
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
IEC 62563-2:2021 © IEC:2021 – 3 –
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
– 4 – IEC 62563-2:2021 © IEC:2021
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 entru
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