BS EN 62563-1-2010 Medical electrical equipment - Medical image display systems - Evaluation methods《医疗电气设备 医用图像显示系统 评估方法》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Medical image display systemsPart 1: Evaluation methodsBS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Unc

2、ontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 62563-1:2010. It isidentical to IEC 62563-1:2009.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2,Diagnosti

3、c imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010ISBN 978 0 580 61145 2ICS 11.040.55C

4、ompliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 May 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 62563-1:2010Licensed

5、 Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 62563-1 NORME EUROPENNE EUROPISCHE NORM March 2010 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr El

6、ektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62563-1:2010 E ICS 11.040.55 English version Medical electrical equipment - Medical image displa

7、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 w

8、as approved by CENELEC on 2010-03-01. 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 su

9、ch national standards may be obtained on application to the Central Secretariat 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

10、language and notified to 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, Irelan

11、d, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSIEN 62563-1:2

12、010 - 2 - Foreword The text of document 62B/743/CDV, future edition 1 of IEC 62563-1, 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 was approved by CENELEC as EN 62563-1 on 2010-03-01. Atte

13、ntion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: latest date by which the EN has to be implemented at national

14、 level by publication of an identical national standard or by endorsement (dop) 2010-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2013-03-01 In this standard, the following print types are used: requirements and definitions: roman type; informa

15、tive 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. Annex ZA has been added by CENELEC. _ Endorsement notice The

16、text of the International Standard IEC 62563-1:2009 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: 1 ISO 9241-302 NOTE Harmonized as EN ISO 9241-302. 19 IEC 61223-2-

17、5 NOTE Harmonized as EN 61223-2-5. 20 ISO 9241-303 NOTE Harmonized as EN ISO 9241-303. 21 ISO 9241-305 NOTE Harmonized as EN ISO 9241-305. 22 ISO 9241-307 NOTE Harmonized as EN ISO 9241-307. _ BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled Cop

18、y, (c) BSI- 3 - EN 62563-1:2010 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For

19、undated 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/HD applies. Publication Year Title EN/HD Year IEC/TR 60788 2004 Medical electric

20、al equipment - Glossary of defined terms - - ISO 11664-1 2007 Colorimetry - Part 1: CIE standard colorimetric observers - - CIE S010/E 2004 Photometry - The CIE system of physical photometry - - BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled C

21、opy, (c) BSI 2 62563-1 IEC:2009 CONTENTS INTRODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms, definitions, symbols and abbreviations7 3.1 Terms and definitions 7 3.2 Symbols 10 3.3 Abbreviations 11 4 General 11 5 Prerequisites 11 6 Equipment and tools.12 6.1 LUMINANCE meter.12 6.2 ILLUMINANCE

22、 meter.12 6.3 Colour meter .12 6.4 TEST PATTERNS 13 7 Evaluation methods 14 7.1 General .14 7.2 Evaluation method table overview .14 7.3 Visual evaluation methods.16 7.3.1 General .16 7.3.2 Overall image quality evaluation 16 7.3.3 Greyscale resolution evaluation.17 7.3.4 LUMINANCE response evaluati

23、on.18 7.3.5 LUMINANCE uniformity evaluation19 7.3.6 Chromaticity evaluation .19 7.3.7 Pixel faults evaluation19 7.3.8 VEILING GLARE evaluation .20 7.3.9 Geometrical image evaluation20 7.3.10 Angular viewing evaluation 21 7.3.11 Clinical evaluation .22 7.4 Quantitative evaluation methods22 7.4.1 Basi

24、c LUMINANCE evaluation.22 7.4.2 Basic LUMINANCE evaluation without ambient light23 7.4.3 LUMINANCE response evaluation.23 7.4.4 LUMINANCE evaluation of multiple displays .26 7.4.5 Chromaticity evaluation .26 7.4.6 Chromaticity evaluation of multiple displays.26 7.4.7 LUMINANCE uniformity evaluation2

25、6 7.4.8 Viewing angle evaluation .26 Annex A (informative) Sample test reports .28 Annex B (informative) LUMINANCE measurement methods 43 Annex C (informative) Description of TEST PATTERNS 46 Bibliography55 Index of defined terms 57 BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STAND

26、ARDS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSI62563-1 IEC:2009 3 Figure 1 Overall image quality evaluation using the TG18-QC TEST PATTERN16 Figure 2 Overall image quality evaluation using the TG18-OIQ TEST PATTERN.17 Figure 3 Magnified view of TG18-MP TEST PATTERN showing the 8-bit and 10-bit ma

27、rkers 18 Figure 4 A close-up of the TG18-CT TEST PATTERN.19 Figure 5 The TG18-GV TEST PATTERN is displayed (left), a close-up of the centre of the TEST PATTERN when covered with a mask (right) 20 Figure 6 Geometrical evaluation using the GD pattern .21 Figure 7 Visual evaluation of viewing angle res

28、ponse 22 Figure 8 Example of the measured LUMINANCE in relation to the standard LUMINANCE response function according to GREYSCALE STANDARD DISPLAY FUNCTION (GSDF) .25 Figure 9 An example of the CONTRAST response computed from 18 grey levels as related to the expected CONTRAST response associated wi

29、th the DICOM 3.14 2 standard LUMINANCE response with a given tolerance limit (e.g. 15 %) 1025 Figure B.1 Method A, telescopic method 43 Figure B.2 Method B, near-range LUMINANCE meter in combination with an ILLUMINANCE meter 44 Figure B.3 Method C, frontal integrated LUMINANCE meter in combination w

30、ith ILLUMINANCE meter 44 Figure B.4 Method D, back integrated LUMINANCE meter in combination with ILLUMINANCE meter 45 Figure C.1 Example of TG-18 QC pattern for a matrix size of 1536 2048.54 Table 1 Overview to the definitions of physical parameters 10 Table 2 TEST PATTERNS used for display testing

31、 .13 Table 3 List of the evaluation methods that can be used for testing medical IMAGE DISPLAY SYSTEMS .15 Table A.1 Acceptance test sample report of a diagnostic display .29 Table A.2 Constancy test sample report of a diagnostic display .33 Table A.3 Acceptance test sample report of a monochrome re

32、viewing display .35 Table A.4 Constancy test sample report of a monochrome reviewing display .37 Table A.5 Acceptance test sample report of a colour reviewing display 39 Table A.6 Constancy test sample report of a colour reviewing display41 Table C.1 Description of multi-purpose TEST PATTERNS.47 Tab

33、le C.2 TG18-QC pattern: LUMINANCE levels with 8-bit and 12-bit pixel values and CX ratings50 Table C.3 The blurring characteristics of the CX reference set utilized in TG18-QC TEST PATTERNS 16 .51 Table C.4 Evaluation criteria for the examples of the CLINICAL REFERENCE IMAGES 52 Table C.5 Example de

34、scription of TG-18 QC pattern for a matrix size of 1536 2048 53 BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSI 6 62563-1 IEC:2009 INTRODUCTION This International Standard provides evaluation methods for testing IMAGE DISPLAY SYST

35、EMS used in MEDICAL ELECTRICAL EQUIPMENT and medical electrical systems for diagnostic imaging. On site or after installation, two types of testing can be carried out. An acceptance test is carried out after a new IMAGE DISPLAY SYSTEM has been installed, or major modifications have been made to the

36、existing IMAGE DISPLAY SYSTEM. Since an IMAGE DISPLAY SYSTEM may degrade over time, the constancy test is carried out by the user in a periodic cycle to verify that the performance is maintained for the intended use. The standard describes various evaluation methods without dictating what particular

37、 tests shall be used for acceptance and/or constancy tests. Rather, it is the intention of this standard to be a reference for other standards and guidelines specific to each modality or to be defined by national authorities who will refer to the evaluation methods of this standard and mention limit

38、ing values and frequencies for acceptance and constancy tests. Annex A shows sample reports of such a reference. To maintain the homogeneity in the IEC standards for MEDICAL ELECTRICAL EQUIPMENT, IEC 61223-2-5, Evaluation and routine testing in medical imaging departments Part 2-5: Constancy tests I

39、mage display devices should be reviewed. BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSI62563-1 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT MEDICAL IMAGE DISPLAY SYSTEMS Part 1: Evaluation methods 1 Scope This part of IEC 62563 descri

40、bes the evaluation methods for testing medical IMAGE DISPLAY SYSTEMS. The scope of this International Standard 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

41、these are beyond the scope of this document. 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 DISPLAYS, PROJECTION SYS

42、TEM). 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 re

43、quirements 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. It is not in the scope of this standard to define the requirements of acceptance and constancy tests no

44、r the frequencies of constancy tests. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendment

45、s) applies. IEC 60788:2004, Medical electrical equipment Glossary of defined terms ISO 11664-1:2007, Colorimetry Part 1: CIE standard colorimetric observers CIE S 010/E:2004 Photometry The CIE system of physical photometry 3 Terms, definitions, symbols and abbreviations 3.1 Terms and definitions For

46、 the purpose of this document, the terms and definitions given in IEC 60788:2004 and the following apply. 3.1.1 accuracy closeness of agreement between a test result and the accepted reference value ISO 5725-1:1994, definition 3.6 BS EN 62563-1:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDAR

47、DS, 01/09/2010 08:32, Uncontrolled Copy, (c) BSI 8 62563-1 IEC:2009 3.1.2 brightness LUMINANCE as perceived by the human visual system 3.1.3 cathode ray tube CRT picture tube component of an IMAGE DISPLAY SYSTEM in which images defined via electrical signals are visualized by means of an electron be

48、am striking a phosphor 3.1.4 clinical reference image specific medical image typical for the intended use of the IMAGE DISPLAY SYSTEM NOTE The anatomical patterns reported in Annex C are examples of CLINICAL REFERENCE IMAGE. 3.1.5 clock artefact artefact in form of distorted vertical bars or stripes

49、, visible on the screens of fixed-pixel type IMAGE DISPLAY DEVICES (e.g. LCD), when the frequency of the internal dot clock is different from that of the incoming analogue signal 3.1.6 contrast ratio of the difference of the LUMINANCE of two image areas, L1- L2, divided by the average of the two LUMINANCE values: CONTRAST = 2 .(L1- L2)/(L1+ L2) 3.1.7 digital driving level DDL digital value given as input