EN 62563-1:2010/A1:2016

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

IEC 62563-1:2009 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 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 (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard.

Medizinische elektrische Geräte - Medizinische Bildwiedergabesysteme - Teil 1: Bewertungsmethoden

Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 1: Méthodes d’évaluation

Medicinska električna oprema - Sistemi za prikazovanje medicinskih slik - 1. del: Metode vrednotenja - Dopolnilo A1

General Information

• Status: Published
• Publication Date: 02-Jun-2016
• Withdrawal Date: 27-Apr-2019
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-Jun-2016
• Completion Date: 03-Jun-2016
• Ref Project: SIST EN 62563-1:2010/A1:2016 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

Relations

• Amends: EN 62563-1:2010 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
• Effective Date: 26-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2016
0HGLFLQVNDHOHNWULþQDRSUHPD6LVWHPL]DSULND]RYDQMHPHGLFLQVNLKVOLNGHO
0HWRGHYUHGQRWHQMD'RSROQLOR$
Medical electrical equipment - Medical image display systems - Part 1: Evaluation
methods
Ta slovenski standard je istoveten z: EN 62563-1:2010/A1:2016
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 62563-1:2010/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2016
ICS 11.040.55
English Version
Medical electrical equipment - Medical image display systems -
Part 1: Evaluation methods
(IEC 62563-1:2009/A1:2016)
Appareils électromédicaux - Systèmes d'imagerie médicale - Medizinische elektrische Geräte - Medizinische
Partie 1: Méthodes d'évaluation Bildwiedergabesysteme - Teil 1: Bewertungsmethoden
(IEC 62563-1:2009/A1:2016) (IEC 62563-1:2009/A1:2016)
This amendment A1 modifies the European Standard EN 62563-1:2010; it was approved by CENELEC on 2016-04-28. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62563-1:2010/A1:2016 E

European foreword
The text of document 62B/983/CDV, future IEC 62563-1:2009/A1, 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/A1:2016.
The following dates are fixed:
(dop) 2017-01-28
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-04-28
• latest date by which the national standards conflicting with
the 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 [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 62563-1:2009/A1:2016 was approved by CENELEC as a
European Standard without any modification.
IEC 62563-1 ®
Edition 1.0 2016-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment – Medical image display systems –

Part 1: Evaluation methods
Appareils électromédicaux – Systèmes d’imagerie médicale –

Partie 1: Méthodes d’évaluation

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-3243-9

– 2 – IEC 62563-1:2009/AMD1:2016
© IEC 2016
FOREWORD
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:
CDV Report on voting
62B/983/CDV 62B/995/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
Introduction to Amendment 1
This amendment is published to introduce colour measurement.
Since publication of IEC 62563-1:2009, IEC 61223-2-5, Evaluation and routine testing in
medical imaging departments Part 2-5: Constancy tests – Image display devices has been
reviewed and withdrawn.
IEC 62563-1:2009/AMD1:2016 – 3 –
© IEC 2016
1 Scope
Replace the first sentence of the third paragraph with the following:
This standard applies to medical IMAGE DISPLAY SYSTEMS, which can display image information
on greyscale and colour IMAGE DISPLAY SYSTEMS.
Add, at the end of the third paragraph, the following new sentence:
Handheld IMAGE DISPLAY SYSTEMS might require additional or modified versions of the
procedures described in this standard.
Replace, in the fourth paragraph, the word “nor” with “or”.
3.2 Symbols
Table 1 – Overview to the definitions of physical parameters
Add, before the last row, the following new row:
a L /L Alternative safety factor. This factor
R amb min
is defined to provide consistency
with other relevant documents
(e.g. ACR–AAPM–SIIM Technical
Standard For Electronic Practice Of
Medical Imaging, Amended 2014,
Resolution 39).
Replace, in the last row, third column, “Maximum distance” by “Distance”.
7.2 Evaluation method table overview
Table 3 – List of the evaluation methods that can be used for testing medical IMAGE
DISPLAY SYSTEMS
Replace, in the fourth but last row, first column, “Chromaticity evaluation” by “Chromaticity
uniformity evaluation”.
Replace, in the third but last row, “Chromaticity evaluation of multiple displays” by
“Chromaticity evaluation across multiple displays”.
Add, at the end of Table 3, the following new row:
Greyscale chromaticity evaluation Colour meter

7.4.4
...