EN 62563-1-2010 en Medical electrical equipment - Medical image display systems - Part 1 Evaluation methods (Incorporates Amendment A1 2016)《医用电气设备 医用图像显示系统 第1部分 评价方法》.pdf

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1、BS EN 62563-1:2010+A1:2016Medical electrical equipment Medical image display systemsPart 1: Evaluation methods (IEC 62563-1:2009)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 62563-1:2010+A1:2016 BRITISH STANDARDNational forewordThis British Standard is the U

2、K implementation of EN 62563-1:2010+A1:2016. It is identical to IEC 62563-1:2009, incorporating amendment 1:2016. It supersedes BS EN 62563-1:2010 which will be withdrawn on 28 April 2019.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicatin

3、g changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipme

4、nt.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI

5、 Standards Limited 2016ISBN 978 0 580 86730 9ICS 11.040.55Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2010.Amendments/corrigenda issued since publicat

6、ionDate Text affected31 July 2016 Implementation of IEC amendment 1:2016 with CENELEC endorsement A1:2016EUROPEAN STANDARD EN 62563-1NORME EUROPENNE EUROPISCHE NORMMarch 2010CENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komit

7、ee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 62563-1:2010 EICS 11.040.55English versionMedical electricalequipment - Medical image displa

8、y systems - Part 1: Evaluation methods (IEC 62563-1:2009)Appareils lectromdicaux -Systmes dimagerie mdicale -Partie 1: Mthodes dvaluation(CEI 62563-1:2009)Medizinische elektrische Gerte -Medizinische Bildwiedergabesysteme -Teil 1: Bewertungsmethoden(IEC 62563-1:2009)This European Standard was approv

9、ed by CENELEC on 2010-03-01. CENELEC members are bound to complywith 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 nationa

10、l standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and

11、 notifiedto the Central Secretariat 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,Latvi

12、a, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,Spain, Sweden, Switzerland and the United Kingdom.BS EN 62563-1:2010EN 62563-1:2010+A1June 2016EN 62563-1:2010 - 2 -Foreword The text of document 62B/743/CDV, future edition 1 of IEC 62563-1, prep

13、ared by SC 62B, Diagnosticimaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 62563-1 on 2010-03-01.Attention is drawn to the possibilitythat some of the elements of this document may be the subject

14、 ofpatent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patentrights.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2010-12-01 latest d

15、ate by which the national standards conflictingwith the EN have to be withdrawn (dow) 2013-03-01In this standard, 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. N

16、ormative text oftables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THIS INTERNATIONAL STANDARD, OR AS NOTED: SMALL CAPITALS.Annex ZA has been added by CENELEC._Endorsement noticeThe text of the International Standard IEC 62563-1:2009 was approved by CENELEC as a European Standard without

17、 any modification.In the official version, for Bibliography, the following notes have to be added for the standards indicated:1ISO 9241-302 NOTE Harmonized as EN ISO9241-302.19 IEC 61223-2-5 NOTE Harmonized as EN 61223-2-5.20 ISO9241-303 NOTE Harmonized as EN ISO9241-303.21 ISO9241-305 NOTE Harmoniz

18、ed as EN ISO9241-305.22 ISO9241-307 NOTE Harmonized as EN ISO9241-307._BS EN 62563-1:2010 4 BS EN 62563-1:2010+A1:2016EN 62563-1:2010:2016+A1:2016 5 BS EN 62563-1:2010+A1:2016EN 62563-1:2010:2016+A1:2016EN 62563-1:2010/A1:2016 2 European foreword The text of document 62B/983/CDV, future IEC 62563-1:

19、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: latest date by which the document has to be implemented

20、 at national level by publication of an identical national standard or by endorsement (dop) 2017-01-28 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2019-04-28 Attention is drawn to the possibility that some of the elements of this document may

21、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. Foreword to ame

22、ndment A1- 3 -EN 62563-1:2010Annex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are indispensable for the application of this document. For dated references, onlythe edition cited applies. For undated

23、references, the latest edition of the referenced document (including any amendments) applies.NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HDapplies.Publication Year Title EN/HD YearIEC/TR60788 2004 Medical electrical equipment

24、-Glossary of defined terms - - ISO 11664-12007 Colorimetry -Part 1: CIE standard colorimetric observers- - CIE S010/E 2004 Photometry - The CIE system of physicalphotometry- - BS EN 62563-1:2010 6 BS EN 62563-1:2010+A1:2016EN 62563-1:2010:2016+A1:2016 2 62563-1 IEC:2009CONTENTSINTRODUCTION.61Scope.7

25、2Normative references.73Terms, definitions, symbolsand abbreviations73.1Terms and definitions73.2Symbols103.3Abbreviations114General115Prerequisites116Equipment and tools.126.1LUMINANCE meter.126.2ILLUMINANCE meter.126.3Colour meter.126.4TEST PATTERNS137Evaluation methods147.1General.147.2Evaluation

26、method table overview.147.3Visual evaluation methods.167.3.1General.167.3.2Overall image quality evaluation167.3.3Greyscale resolution evaluation.177.3.4LUMINANCE response evaluation.187.3.5LUMINANCE uniformity evaluation197.3.6Chromaticity evaluation.197.3.7Pixel faultsevaluation197.3.8VEILING GLAR

27、E evaluation.207.3.9Geometrical image evaluation207.3.10 Angular viewing evaluation217.3.11 Clinical evaluation.227.4Quantitative evaluation methods227.4.1Basic LUMINANCE evaluation.227.4.2Basic LUMINANCE evaluation withoutambient light237.4.3LUMINANCE response evaluation.237.4.4LUMINANCE evaluation

28、 of multiple displays.267.4.5Chromaticity evaluation.267.4.6Chromaticity evaluation of multiple displays.267.4.7LUMINANCE uniformity evaluation267.4.8Viewing angle evaluation.26Annex A(informative) Sample test reports.28Annex B (informative) LUMINANCE measurement methods 43Annex C (informative) Desc

29、ription of TEST PATTERNS46Bibliography55Indexof defined terms57BS EN 62563-1:2010 2 2563-1 IEC:2009CONTENTSINTRODUCTION.61Scope.72Normative references.73Terms, definitions, symbolsand abbreviations73.1Terms and definitions72Symbols 103Abbreviations114General5Prerequisites116Equipment and tools.126.1

30、LUMINANCE meter.122ILLUMINANCE meter3Colour meter.124TEST PATTERNS137Evaluation methods 147.1General.142Evaluationmethod table overview.3Visual evaluation methods. 167.3.1General2Overall image quality evaluation3Greyscale resolution evaluation.174LUMINANCE response 185L uniformity evaluation 196Chro

31、maticity evaluation.7Pixel faultsevaluation8VEILING GLARE evaluation. 209Geometrical image evaluation10 Angular viewing evaluation2111 Clinical evaluation 227.4Quantitative evaluation methods7.4.1Basic LUMINANCE evaluation.2B n withoutambient light 233LUMINANCE response evaluation.4L evaluation of m

32、ultiple displays.265Chromaticity evaluation.6C n of multiple displays.7LUMINANCE uniformity evaluation8Viewing angle evaluation.Annex A(informative) Sample test reports. 28Annex B (informative) LUMINANCE measurement methods 43Annex C (informative) Description of TEST PATTERNS46Bibliography55Indexof

33、defined terms57BS EN 62563-1:2010BS EN 62563-1:2010+A1:2016IEC 62563-1:2009+A1:2016 7 7.4.9 Greyscale chromaticity evaluation 91010101013141414151515151617171719191920212222222323242525252626292929292930314851606262563-1 IEC:2009 3 Figure 1 Overall image quality evaluation using the TG18-QC TEST PAT

34、TERN16Figure 2 Overall image quality evaluation using the TG18-OIQ TEST PATTERN.17Figure 3 Magnified view ofTG18-MP TEST PATTERN showing the 8-bit and 10-bitmarkers18Figure 4 A close-up of the TG18-CT TEST PATTERN.19Figure 5 The TG18-GV TEST PATTERN is displayed (left), a close-up ofthe centre ofthe

35、 TEST PATTERN whencovered with a mask (right)20Figure 6 Geometrical evaluation using theGD pattern.21Figure 7 Visual evaluation of viewing angle response22Figure 8 Example of the measured LUMINANCE in relation to the standard LUMINANCEresponse function according to GREYSCALE STANDARD DISPLAY FUNCTIO

36、N (GSDF).25Figure 9 An example ofthe CONTRAST responsecomputed from 18 greylevels asrelated to the expected CONTRAST response associated with the DICOM 3.14 2standard LUMINANCE response withagiven tolerance limit (e.g. 15 %) 1025Figure B.1 Method A, telescopic method43Figure B.2 Method B, near-range

37、 LUMINANCE meter in combination with anILLUMINANCE meter44Figure B.3 MethodC,frontal integrated LUMINANCE meter incombination with ILLUMINANCE meter44Figure B.4 MethodD, back integrated LUMINANCE meter incombination withILLUMINANCE meter45Figure C.1 Example of TG-18 QC pattern fora matrix size of 15

38、36 2048.54Table1Overview to the definitions of physical parameters10Table 2 TEST PATTERNS used for display testing.13Table 3 List of the evaluation methods that can be usedfortesting medical IMAGE DISPLAY SYSTEMS.15Table A.1 Acceptance test sample report ofa diagnostic display.29Table A.2 Constancy

39、test sample report of a diagnostic display.33Table A.3 Acceptance test sample report of a monochrome reviewing display.35Table A.4 Constancy test sample report of a monochrome reviewing display.37Table A.5 Acceptance test sample report of a colour reviewing display39Table A.6 Constancy test sample r

40、eport of a colourreviewing display41Table C.1 Description of multi-purpose TEST PATTERNS.47Table C.2 TG18-QC pattern:LUMINANCE levels with 8-bit and 12-bit pixel valuesand CX ratings50Table C.3 The blurring characteristics of the CX reference set utilized in TG18-QCTEST PATTERNS 16.51Table C.4 Evalu

41、ation criteria for the examplesof the CLINICAL REFERENCE IMAGES 52Table C.5 Example description of TG-18 QC pattern for a matrix sizeof1536 204853BS EN 62563-1:2010BS EN 62563-1:2010+A1:2016IEC 62563-1:2009+A1:2016 8 19202122232425282848494950591316183236394143465255565758 6 62563-1 IEC:2009INTRODUC

42、TION This International Standard providesevaluation methods for testing IMAGE DISPLAY SYSTEMSused in MEDICAL ELECTRICAL EQUIPMENT and medical electricalsystems for diagnostic imaging.On site or after installation, two types of testing can be carried out. An acceptance testis carried out after a new

43、IMAGE DISPLAY SYSTEM has been installed, or major modifications havebeen made to the existing IMAGE DISPLAY SYSTEM. Since an IMAGE DISPLAY SYSTEM maydegrade over time, the constancy test is carried out by the userin a periodic cycle to verifythat the performance is maintained for the intended use.Th

44、e standard describes various evaluation methods without dictating what particular testsshall be used for acceptance and/or constancytests.Rather, it is the intention of this standard to be a reference for other standards and guidelinesspecific to each modalityor to be defined by national authorities

45、 who will refer to the evaluation methods of this standard and mention limiting valuesand frequencies foracceptance and constancy tests. Annex A shows sample reports of sucha reference. To maintain the homogeneity in the IEC standards for MEDICAL ELECTRICAL EQUIPMENT, IEC 61223-2-5, Evaluation and r

46、outine testing in medical imaging departments Part 2-5:Constancy tests Image display devices should be reviewed.BS EN 62563-1:2010BS EN 62563-1:2010+A1:2016IEC 62563-1:2009+A1:2016 9 62563-1 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT MEDICAL IMAGE DISPLAY SYSTEMS Part 1: Evaluationmethods 1 Scope This

47、partof IEC62563 describes theevaluationmethods for testing medical IMAGE DISPLAY SYSTEMS. The scope of this International Standard is directed to practical tests thatcan be visuallyevaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on t

48、hese devices, but these are beyond the scope of thisdocument. This standard 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 DISPLAY

49、S, PROJECTION SYSTEM).This standard applies to medical IMAGE DISPLAY SYSTEMS used fordiagnostic (interpretation ofmedical imagestoward rendering clinical diagnosis) or viewing (viewing medical images formedical purposes other than for providing a medical interpretation) purposesand thereforehaving specific requirements in terms of image quality. Head mounted IMAGE DISPLAY SYSTEMSand IMAGE DISPLAY SYSTEMS usedfor confirming posi