DIN 6868-157-2014 Image quality assurance in diagnostic X-ray departments - Part 157 X-ray ordinance acceptance and constancy test of image display systems in their environment《X射线.pdf

1、November 2014DEUTSCHE NORM English price group 20No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.50!%Q“24695

2、92www.din.deDIN 6868-157Image quality assurance in diagnostic Xray departments Part 157: Xray ordinance acceptance and constancy test of image display systems in their environment,English translation of DIN 6868-157:2014-11Sicherung der Bildqualitt in rntgendiagnostischen Betrieben Teil 157: Abnahme

3、 und Konstanzprfung nach RV an Bildwiedergabesystemen in ihrer Umgebung,Englische bersetzung von DIN 6868-157:2014-11Assurance de la qualit des images en diagnostic radiographique Partie 157: Test dacceptance et contrle de constance selon RV des systmes de visualisation des images dans leur environn

4、ement,Traduction anglaise de DIN 6868-157:2014-11SupersedesDIN V 686857:200102www.beuth.deDocument comprises 56 pagesDDIN-Normenausschuss Radiologie (NAR)DIN-Sprachendienst08.16 DIN 6868-157:2014-11 2 A comma is used as the decimal marker. Content Page Foreword . 4 1 Scope 6 2 Normative references 6

5、 3 Terms and definitions . 7 4 Symbols and abbreviations . 13 5 Test conditions . 14 6 Test equipment 15 6.1 General 15 6.2 Luminance meter . 15 6.2.1 Luminance meter for the acceptance test . 15 6.2.2 Luminance meter for the constancy test . 15 6.3 Illuminance meter / luxmeter 15 6.4 Test images 16

6、 7 Room classes . 17 8 Acceptance test for image display systems with diagnostic quality . 19 8.1 Scope of testing . 19 8.2 Visual tests . 20 8.2.1 General 20 8.2.2 Overall image quality . 20 8.2.3 Greyscale resolution of the IMAGE DISPLAY DEVICE . 22 8.2.4 LUMINANCE uniformity (visual) . 23 8.2.5 C

7、olour impression and uniformity 23 8.2.6 Pixel errors 24 8.2.7 Image geometry 24 8.2.8 Test based on clinical reference images . 25 8.2.9 Additional tests for mammography image display systems 25 8.3 Metrological tests 25 8.3.1 Minimum luminance 25 8.3.2 Maximum luminance 25 8.3.3 Ambient luminance

8、. 25 8.3.4 Illuminance 25 8.3.5 Maximum luminance ratio . 25 8.3.6 Uniformity of the image display device . 26 8.3.7 Uniformity of multiple image display devices 27 8.3.8 Luminance response curve 27 8.4 Minimum requirements (without mammography) . 28 8.5 Additional requirements for image display sys

9、tems used for mammography . 30 8.6 Mobile systems . 31 9 Reference values for the constancy test 31 10 Constancy test for image display systems with diagnostic quality . 31 DIN 6868-157:2014-11 3 11 Significant changes to an image display system . 33 12 Image display systems with review quality . 33

10、 Annex A (normative) Methods of measuring luminance 34 A.1 General 34 A.2 Measurement methods 34 A.2.1 Method A: Telescopic method . 34 A.2.2 Method B: Close-range luminance meter in combination with a luxmeter . 35 A.2.3 Method C: Front-integrated luminance meter in combination with a luxmeter . 36

11、 A.2.4 Method D: Back-integrated luminance meter in combination with an illuminance meter/luxmeter 37 A.3 Notes on the measuring methods 37 Annex B (informative) Typical errors 38 Annex C (informative) Test report templates . 39 C.1 Example of a test report template for the acceptance test . 39 C.2

12、Example of a test report template for the constancy test . 50 C.3 Example of a test report template for the daily constancy test 52 Bibliography . 53 Keyword index. 55 Figures Figure 1 Test images for use on image display systems (images a) through f) according to DIN EN 62563-1:2014-01, Table 2, an

13、d images g) through l) according to AAPM). 16 Figure 2 Overall image quality test using test image TG18-OIQ 22 Figure 3 Enlarged view of test image TG18-MP, depicting the 8-bit and 10-bit markers 23 Figure 4 Positions of the measuring points for the luminance uniformity test . 26 Figure A.1 Method A

14、 Telescopic method . 34 Figure A.2 Method B Close-range luminance meter in combination with a luxmeter 35 Figure A.3 Method C Front-integrated luminance meter in combination with luxmeter . 36 Figure A.4 Method D Back-integrated luminance meter in combination with a luxmeter . 37 Tables Table 1 Defi

15、nition of room classes with their respective requirements 18 Table 2 Visual tests for acceptance testing 19 Table 3 Metrological tests for acceptance testing . 20 Table 4 Minimum requirements for image display devices 28 Table 5 Additional requirements for image display systems used in mammography a

16、nd stereotactic mammography 30 Table 6 Visual tests for the constancy test . 32 Table 7 Metrological test items in the constancy test 32 DIN 6868-157:2014-11 4 Foreword This standard has been prepared by Working Committee NA 080-00-06 AA Bildgebende Systeme of DIN-Normenausschuss Radiologie (NAR) (D

17、IN Standards Committee Radiology) together with the Deutsche Rntgengesellschaft (German Radiological Society) and in collaboration with the Deutsche Gesellschaft fr Medizinische Physik (DGMP) (German Society for Medical Physics), the Deutsche Gesellschaft fr Nuklearmedizin (DGN) (German Society for

18、Nuclear Medicine), and the Deutsche Gesellschaft fr Radioonkologie (DEGRO) (German Society for Radiation Oncology). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such

19、patent rights. This standard contains specifications within the meaning of the Rntgenverordnung (German X-ray Ordinance) 21 and the Richtlinie zur Durchfhrung der Qualittssicherung bei Rntgeneinrichtungen zur Untersuchung oder Behandlung von Menschen nach den 16 und 17 der Rntgenverordnung (QS-RL) (

20、German Guidelines on quality assurance procedures for X-ray equipment used to examine or treat humans in accordance with sections 16 and 17 of the Rntgenverordnung (X-ray Ordinance) 22. In accordance with IEC practice, defined concepts are written in small capitals in this standard. A keyword index

21、at the end of the standard contains all defined concepts, including source(s) and a German translation. DIN 6868 consists of the following parts, under the general title Image quality assurance in X-ray departments Part 1: General Part 2: Constancy testing of film processing Part 3: Constancy testin

22、g in direct radiography Part 4: Constancy testing of medical X-ray equipment for fluoroscopy Part 5: RV constancy testing of dental radiographic equipment Part 7: Constancy testing of mammographic X-ray equipment Part 12: Constancy tests for hard copy cameras Part 13: RV constancy test of projection

23、 radiography systems with digital image receptors Part 14: RV constancy testing of X-ray installations for digital mammography Part 15: RV constancy testing of X-ray installations for dental radiographic equipment for digital cone-beam computed tomography Part 55: Acceptance testing in direct radiog

24、raphic and fluoroscopic X-ray-systems including film processing Part 56: Acceptance testing for hard copy cameras Part 150: RV acceptance test of medical radiographic and fluoroscopic X-ray equipment DIN 6868-157:2014-11 5 Part 151: Acceptance testing of dental radiographic equipment according to RV

25、 Rules for the inspection of image quality after installation, maintenance and modification Part 152: RV acceptance test of X-ray installations for screen/film mammography Part 157: X-ray Ordinance acceptance and constancy test of image display systems in their environment Part 159: Acceptance and c

26、onstancy testing in teleradiology according to RV Part 160: Quality requirements for diagnostic non-transparent X-ray pictures in dental radiology Part 161: RV acceptance testing of dental radiographic equipment for digital cone-beam computed tomography Part 162: RV acceptance test of X-ray installa

27、tions for digital mammography In addition to the legal units of measurement, this standard also uses the unit “inch”. It is important to note that according to the German law on units in metrology, the use of the unit “inch” is not permitted in official or business communications within Germany. Con

28、version: 1 inch 25,4 mm. Amendments This standard differs from DIN V 6868-57:2001-02 as follows: a) the prestandard status has been changed to that of a full standard; b) the title has been changed; the title now includes the environment of the IMAGE DISPLAY DEVICE; c) the CONSTANCY TEST has been ad

29、ded; d) the standard has been brought in line with the current state of the art; e) room classes have been introduced for the use of IMAGE DISPLAY SYSTEMS; f) the DICOM characteristic curve has been made obligatory for IMAGE DISPLAY SYSTEMS with DIAGNOSTIC QUALITY, with the exception of dental medic

30、ine; g) limits for PIXEL errors have been added; h) measuring methods and TEST IMAGES have been brought in line with DIN EN 62563-1; i) the scope has been extended to include dental medicine, and magnetic resonance tomography has been removed. Previous editions DIN V 6868-57: 2001-02 DIN 6868-157:20

31、14-11 6 1 Scope This standard contains defining parameters for the ACCEPTANCE and CONSTANCY TESTING of IMAGE DISPLAY SYSTEMS in the context of the Rntgenverordnung RV (German X-ray Ordinance); it describes test methods and defines LIMITING VALUES as well as test intervals. This standard applies to m

32、edical IMAGE DISPLAY SYSTEMS with DIAGNOSTIC QUALITY that reproduce colour or greyscale image information on IMAGE DISPLAY DEVICES. This includes the monochrome or colour IMAGE DISPLAY DEVICES used on modalities in the medical diagnostic procedures computed tomography (CT), radiography (including de

33、ntistry, mammography and stereotactic mammography), fluoroscopy, digital subtraction angiography (DSA) as well as those used at workplaces where DIAGNOSTIC QUALITY of IMAGE DISPLAY SYSTEMS is required, usually in conjunction with a PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS). Minimum requireme

34、nts are specified for IMAGE DISPLAY SYSTEMS with REVIEW QUALITY. This standard does not describe test methods that would permit an evaluation of colour reproduction. This standard defines the required identification of IMAGE DISPLAY DEVICES. This standard does not apply to IMAGE DISPLAY SYSTEMS that

35、 use CATHODE RAY TUBE (CRT) or head-mounted IMAGE DISPLAY DEVICES. Furthermore, this standard does not apply to IMAGE DISPLAY DEVICES intended solely for the depiction of alpha-numeric characters and graphics. 2 Normative references The following documents, in whole or in part, are normatively refer

36、enced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest version of the referenced document (including any amendments) applies. DIN 5032-7, Photometry; classification of illuminance meters and luminance

37、 meters DIN EN 62563-1:2014-01, Medical electrical equipment Medical image display systems Part 1: Evaluation methods (IEC 62563-1:2009) American Association of Physicists in Medicine (AAPM), Task Group 18, Assessment of Display Performance for Medical Imaging Systems, http:/deckard.mc.duke.edu/same

38、i/tg18 DIN 6868-157:2014-11 7 3 Terms and definitions For the purposes of this document, the terms and definitions in the keyword index and the following apply. NOTE Text in angle brackets (e.g., ) before the definition restricts the scope of the definition to a specific field. 3.1 acceptance test f

39、or X-RAY EQUIPMENT intended for the examination of humans, a test to determine that, during its intended use, the requisite image quality is achieved with the lowest possible radiation exposure, and to determine the reference values for the CONSTANCY TEST Note 1 to entry: This definition, derived fr

40、om 16 RV 21, restricts the term, which can have various meanings. In the German X-ray Ordinance, the term is not limited to X-RAY EQUIPMENT for imaging. In addition, it is also used for tests agreed between a manufacturer or supplier and a customer. SOURCE: DIN 6868-162:2013-06, 3.1 3.2 analog inter

41、face an INTERFACE for forwarding analog SIGNALS defined by the cabling and video standard applied 3.3 application software software used as a component of a medical device or at workplaces to display medical images 3.4 artefact structure visible in the image that does not represent a structure in th

42、e object SOURCE: DIN EN 61223-3-4:2001-10, 3.3.1 3.5 diagnostic quality characteristic of an IMAGE DISPLAY SYSTEM that enables the detection, description and evaluation of image contents containing organ-typical image features, details and critical structures in order to answer diagnostic questions,

43、 and that serves as the basis for medical decisions 3.6 illuminance E ratio of the LUMINOUS FLUX incident on a surface to the area of the illuminated surface Note 1 to entry: The unit for ILLUMINANCE is the lux (lx). SOURCE: DIN 5031-3:1982-03, 3.1.6, modified, Note 1 to entry added 3.7 review quali

44、ty characteristic of an IMAGE DISPLAY SYSTEM that facilitates the detection of image features and content of previously diagnosed images for the purpose of medical information, demonstration and review DIN 6868-157:2014-11 8 Note 1 to entry: In REVIEW QUALITY displays, the presentation of image cont

45、ent may be limited by reduced spatial and contrast resolution and/or reduced LUMINANCE. 3.8 picture archiving and communication system PACS system that can be used, among other things, for the viewing, diagnosis and archiving of medical content, such as images 3.9 image display device IDD display fu

46、nctional unit of an IMAGE DISPLAY SYSTEM, based on active or passive display elements, that receives SIGNALS from an analog or DIGITAL INTERFACE and presents them as a matrix of PIXELS Note 1 to entry: IMAGE DISPLAY DEVICES can be implemented, for example, as liquid crystal displays (LCD), plasma di

47、splay panels (PDP), field emission displays (FED), screens with surface-conductive electron-emitter displays (SED), carbon nanotube screens (CNT display) or displays with organic light-emitting diodes (OLED). 3.10 image display system IDS workplace comprising one or more IMAGE DISPLAY DEVICES and a

48、display control unit, as well as computer hardware and software, that can display images Note 1 to entry: A display control unit may take the form of a DISPLAY CONTROLLER (graphics card). 3.11 digital interface an INTERFACE for forwarding digital SIGNALS, defined by the cabling, the data transmissio

49、n protocols and the encoding of image information 3.12 digital driving level DDL digital value input to an IMAGE DISPLAY SYSTEM to produce a LUMINANCE 3.13 window setting display of a contiguous subset of the pixel values present in the digital image Note 1 to entry: The WINDOW SETTING is determined by the window width and window level (centre) and can be u