EN 61223-3-1-1999 en Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1 Acceptance Tests - Imaging Performance of X-Ray Equipment for Radiographic and Radiosc.pdf

1、STD.BSI BS EN bL223-3-L-ENGL L999 Lb24bb9 0789282 792 BRITISH STANDARD Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging peformance of X-ray equipment for radiographic and radioscopic systems The European Standard EN 6122331:1!3!35 has the status of

2、 a British Standasd ICs 11.040.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 61223-3-1:1999 IEC 61223-3-1:1999 STD.BSI BS EN bL223-3-1-ENGL 1999 Lb24bb9 0789283 b29 9 direction of the Health and Amd. No. Date Environment Sector Committee, was published under the aut

3、hority of the Standards Comniitee and comes into effect on 15 August 1999 O BSI 08-1999 BS EN 61223-3-1:1999 Comments National foreword This British Standard is the English language version of EN 61223-3-1: 1999. It is identical with IEC 612233-1:lW. The UK participation in its preparation was entru

4、sted to Technical Committee Cw73, X-ray equipment, components, protection and utilization, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible internationallEuropean committee any enquiries on the interpretation, or proposals for change, and keep the

5、 LJK interests informed; - monitor related intemational and European developments and promulgate them in the UK A list of organizations represented on this committee can be obtained on request to its secretary. From 1 Januaq 1997, all IEC publications have the number 60000 added to the old number. F

6、or instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contah identierc from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex

7、which lists nonnative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspond

8、ence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of

9、itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 49 and a back cover. The BSI copyright notice displayed throughout this document indicates when the document was last issued ISBN O 580 32753 1

10、I l STDmBSI BS EN b1223-3-1-ENGL 1999 1624669 0787284 565 D EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61 223-311 May 1999 ICs 11.040.50 English version Evaluation and routine testing in medical imaging departments Part 3-1 : Acceptance tests - Imaging performance of X-ray equipment for ra

11、diographic and radioscopic systems (IEC 61 223-3-1 :1999) Essais dvaluation et de routine dans les services dimagerie mdicale Partie 3-1 : Essais dacceptation Performance dimagerie des appareils rayonnement X pour systmes radiographiques et radioscopiques (CE1 6 1 223-3-1 : 1 999) Bewertung und rout

12、inemige Prfung in Abteilungen fr medizinische Bildgebung Teil 3-1 : Abnahmeprfungen Bildgebungsleistung der Rntgeneinrichtung bei radiographischen und Durchleuchtungs-Systemen (IEC 61 223-3-1 1999) This European Standard was approved by CENELEC on 1999-05-01. CENELEC members are bound to comply with

13、 the CENICENELEC 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 Central Secretaria

14、t 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 Central Secretariat has the same status as the of

15、ficial versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee

16、for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 1999 CENELEC - Ail rights of exploitation in any form and by any means reserved worldwide for CENELEC membe

17、rs. Ref. No. EN 61 223-3-1 :1999 E STD*BSI BS EN bL223-3-l-ENGL L999 W lb24bb9 0789285 4Tl Page 2 EN 61223-3-1: 1999 Foreword The text of document 6281361 /FDIS, future edition 1 of IEC 61 223-3-1, prepared by SC 626, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practi

18、ce, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 6 1 223-3-1 on 1999-05-01. The following dates were fixed: - latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2000-02-01 -

19、latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2002-05-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annexes A and ZA are normative and annexes

20、 B, C, D and E are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 61 223-3-1 :I 999 was approved by CENELEC as a European Standard without any modification. Page 3 EN 61223-3-1:1999 CONTENTS Page INTRODUCTION 5 Clause Scope and object .

21、 6 1.1 Scope . 6 1.2 Object . 6 Normative references . 7 Terminology . 8 3.1 Degree of requirements . 8 3.2 Use of terms . 8 3.3 Defined terms . 8 General aspects Of ACCEPTANCE TESTS . 9 4.1 General conditions to be considered in test procedures . 9 4.2 Documents and data for the tests 9 4.3 Test co

22、nditions 9 4.4 Test parameters 10 Evaluating the test results . 12 Visual and functional tests . 13 X-RAY TUBE VOLTAGE . 13 FOCAL SPOT of the X-RAY TUBE 14 Limitation and indication of the extent of the X-RAY BEAM 15 4.5 Test equipment including PHANTOMS (ATTENUATION devices) and TEST DEVICES . 11 4

23、.6 Test methods for RADIOGRAPHY EQUIPMENT . 13 5.1 5.2 5.3 TOTAL FILTRATION . 14 5.4 5.5 5.6 Linearity and reproducibility Of TRANSMISSION KERMA Or RADIATION OUTPUT . 17 5.7 5.8 5.9 ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 18 AUTOMATIC EXPOSURE CONTROL (AEC) 18

24、LINE PAIR RESOLUTION for DIRECT RADIOGRAPHY . 20 5.10 AIR KERMA area product indicator 20 6.1 Visual and functional tests . 20 6.3 TOTAL FILTRATION 21 6.4 FOCAL SPOT of the X-RAY TUBE . 21 Test methods for RADIOSCOPY EQUIPMENT . 20 6.2 X-RAY TUBE VOLTAGE 21 6.5 Functioning Of the AUTOMATIC EXPOSURE

25、RATE CONTROL (AERC) . 21 6.6 Limitation of the extent of the X-RAY BEAM . 22 Q BSI 08-1999 STD.BS1 BS EN b2223-3-L-ENGL 2999 Lb24669 0789287 274 m Page 4 EN 61223-3-1:1999 Clause 6.7 6.0 6.9 6.10 6.1 1 6.12 6.13 6.14 Page ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR

26、 23 for RADIOSCOPY . 23 *AIR KERMA RATE at the ENTRANCE PLANE Of the X-RAY IMAGE INTENSIFIER *Entrance AIR KERMA RATE for RADIOSCOPY with X-RAY IMAGE INTENSIFIER 24 AIR KERMA at the ENTRANCE PLANE Of the X-RAY IMAGE INTENSIFIER for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY SyStemS (excluding dig

27、ital systems) . 25 (excluding digital systems) 25 systems) . 26 systems ) . 27 AIR KERMA area product indicator . 28 Entrance AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY SyStemS *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY 01 other INDIREC

28、T RADIOGRAPHY Systems (excluding digital LOW CONTRAST RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital 7 Additional tests required for TOMOGRAPHY EQUIPMENT 28 7.1 Requirements . 28 7.2 Test method . 29 Test report

29、 and statement of compliance 29 8 Annex A (normative) Terminology . Index of defined terms . 36 Annex B (informative) Test parameters. symbols and units . 39 Annex C (informative) Examples of low contrast TEST DEVICES . 40 Annex D (informative) Examples of requirements (accuracy. tolerances. discrep

30、ancies) according to actual IEC standards or state of the art . 42 Annex E (informative) Bibliography . 46 Annex ZA (normative) Normative references to international publications with their corresponding European publications . 48 Tables B.l Test parameters. symbols and units . 39 D.2 Values for the

31、 discrepancy parameters X. Y and Z according to IEC 60601 -1 -3 43 0.3 Typical values for the TRANSMISSION KERMA index . 43 0.4 44 D.l Typical values Of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES 42 Typical values for the ATTENUATION RATIO Of material between the PATIENT and the X-RAY IMAGE

32、 RECEPTOR Figures 1 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT for AIR KERMA measurements . 31 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT to test geometry and resolutions 32 4 TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE . 34 5 Discrepancies in visual indicatio

33、n of the X-RAY FIELD 35 2 3 LINE PAIR RESOLUTION TEST ZfVICE . 33 6 Discrepancies in Covering the IMAGE RECEPTION AREA . 35 O BSI 08-1999 Page 5 EN 61223-3-1:1999 INTRODUCTION This standard is part of a series of International Standards which give methods of acceptance testing and constancy testing

34、for subsystems and systems (for example diagnostic X-RAY EQUIPMENT), including film processing, used in medical imaging departments. Some provisions or statements in this standard require additional information. Such information is presented in annex D. An asterisk in the left margin of a clause or

35、subclause indicates the presence of such additional information. STD-BSI BS EN 61223-3-1-ENGL 1999 1b24bb9 0789289 047 = Page 6 EN 61223-3-1:1999 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - Part 3-1 : Acceptance tests - Imaging performance of X-ray equipment for radiographic and

36、radioscopic systems 1 Scope and object 1.1 Scope This part of IEC 61223 applies to those components of X-RAY EQUIPMENT which influence the image quality and PATIENT dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems. This standard applies to the performance of X-RAY

37、EQUIPMENT in the ACCEPTANCE TEST On the f0llOWing medical diagnostic X-RAY EQUIPMENT and ASSOCIATED EQUIPMENT: - radiography equipment, for example: Stationary radiography EQUIPMENT; mobile radiography EQUIPMENT; S kull radiography EQUIPMENT; lung radiography EQUIPMENT; TOMOGRAPHY EQUIPMENT - exclud

38、ing COMPUTED TOMOGRAPHY; radiography devices (SPOTFILM DEVICES) in RADIOSCOPY EQUIPMENT; angiography EQUIPMENT (excluding DSA function); CINERADIOGRAPHY equipment; - RADIOSCOPY EQUIPMENT, including: combined radiographic and radioscopic EQUIPMENT. This standard applies to the generation of X-RADIATI

39、ON and ACCESSORIES of digital systems. it does not apply to any digital image acquisition or image processing parts of the above mentioned diagnostic X-RAY EQUIPMENT. NOTE - Since the characterization of digital detectors and image processing is still under development, this will be included in a la

40、ter edition of this standard. This standard does not apply to mammographic X-RAY EQUIPMENT, RADIOTHERAPY SfnUlatOrS, nor to dental X-RAY EQUIPMENT. 1.2 Object This standard defines: a) the parameters which describe the performance of X-RAY EQUIPMENT with regard to imaging properties and PATIENT dose

41、; b) methods of testing whether measured quantities related to those parameters comply with the specified tolerances. STDIBSI BS EN bL223-3-3-ENGL L999 lb24bb9 0789290 - “should“ - “may“ - “specific“ indicates a strong recommendation that is not mandatory for compliance; indicates a permitted manner

42、 of complying with a requirement or of avoiding the need to comply; is used to indicate definitive information stated in this standard or referenced in other standards, usually concerning particular operating conditions, test arrangements or values connected with compliance; - “specified“ is used to

43、 indicate definitive information stated by the MANUFACTURER in under consideration, usually concerning its intended purposes, or the parameters or conditions associated with its use or with testing to determine compliance. ACCOMPANYING DOCUMENTS or in other documentation relating to the EQUIPMENT 3.

44、2 Use of terms In this standard, terms printed in SMALL CAPITALS are used as defined in IEC 60601-1, IEC 60788, IEC 61 223-1 and in 3.3 of this standard (see annex A). NOTE - Attention is drawn to the fact, that, in cases where the concept addressed is not strongly confined to the definition given i

45、n one of the publications listed above, a corresponding term is printed in lower case letters. 3.3 Defined terms 3.3.1 ARTIFACT apparent structure visible in the image which does not represent a structure within the object and which cannot be explained by noise or the MODULATION TRANSFER FUNCTION Of

46、 the SyStem 3.3.2 LINE PAIR RESOLUTION highest spatial frequency of the specified line-group test pattern imaged under specified conditions which is distinguishable in the image. The unit is Ip/rnm NOTE - LINE PAIR RESOLUTION is used here as a practical substitute for spatial resolution. 3.3.3 lowes

47、t contrast detail object of a specified shape and area that can be resolved from an u niform background LOW CONTRAST RESOLUTION 3.3.4 RADIATION OUTPUT AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in the prtTIary X-RAY BEAM 3.3.5 TRANSMISSION KERMA (TRANSMISSIO

48、N KERMA RATE) AIR KERMA (AIR KERMA RATE) in the central X-RAY BEAM behind the specified attenuating laler STD-BSI BS EN bL223-3-1-ENGL 1999 m 1624669 0789272 b3L Page 9 EN 61223-3-1:1999 4 General aspects Of ACCEPTANCE TESTS 4.1 The aim of an ACCEPTANCE TEST is to demonstrate that the specified char

49、acteristics of the equipment lie within the specified tolerances. Some requirements are enforced by legislation. Other requirements and specifications may be in the order contract, in the suppliers brochure or in other standards, for example in the IEC 60601 series. General conditions to be considered in test procedures Before any ACCEPTANCE TEST according to this standard is carried out, the EQUIPMENT has to be installed and put into service according to the set-up procedure as given in the MANUFACTURERS documentation. An inventory Of the EQUIPMENT u