1、 STD-BSI BS EN bL223-3-4-ENGL 2000 Lb24bb 08838bI 769 m BRITISH STANDARD Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment The European Standard EN 6122354:2000 has the status of a British Standard ICs 11.040.50
2、; 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT JAW BS EN 61223-3-4:2000 IEC 61223-342000 STD-BSI BS EN bL223-3-4-ENGL 2000 II Lb24bh9 O38b2 AT5 ai BS EN 61223-3-4:2000 been prepared under the direction of the Health and Environment Sector Committee, was published unde
3、r the authority of the Standards Committee and comes into effect on 15 December 2000 Amd.No. O BSI 12-2000 National foreword Date Comments This British Standard is the official English language version of EN 61223-3-42000. It is identical with IEC 6122334:2. The UK participation in its preparation w
4、as entrusted to Technical Committee CW3, X-ray equipment components, protection and utilization, which has the responsibity to: - aid enquirers to understand the text; - present to the responsible internatio - monitor related international and European developments and promulgate them in the UK. A l
5、ist of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, EC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numb
6、ering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. T
7、he British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does
8、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 itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside
9、 front cover, the EN title page, pages 2 to 35 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. ISBN O 580 36149 7 - - STD-BSI ES EN bL223-3-4-ENGL 2000 Lb24bb9 OB83Bb3 731 E EUROPEAN STANDARD EN 61223-3-4 NORME EUROPEENNE EUROPISCHE
10、NORM September 2000 ICs 11.040.50 English version Evaluation and routine testing in medical imaging departments Part 3-4: Acceptance tests Imaging performance of dental X-ray equipment (IEC 61 223-3-412000) Essais dvaluation et de routine dans les services dimagerie mdicale Partie 3-4: Essais daccep
11、tation Performance dimagerie des appareils de radiographie dentaire zahnrztlichen Rntgeneinrichtungen Bewertung und routinemige Prfung in Abteilungen fr medizinische Bildgebung Teil 3-4: Abnahmeprfungen Leistungsmerkmale zur Bildgebung von (CE1 61 223-3-4:2000) (IEC 61223-3-4:2000) This European Sta
12、ndard was approved by CENELEC on 2000-06-01. CENELEC members are bound to comply with the CENICENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Upto-date lists and bibliographical references concern
13、ing such 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 it
14、s own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Bdgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, P
15、ortugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Cornmittee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: me de Stassart 35,B - 1050 BIUSIS (9 2000 CENELEC - All right
16、s of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61223-3-4:2000 E STD-BSI BS EN b2223-3-4-ENGL 2000 iaa Lb2Libb9 08838b4 678 ai Page 2 EN 61223-3-42000 Foreword The text of document 626/393/FDIS, future edition 1 of IEC 61223-3-4, prepared by SC 626,
17、 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 61223-3-4 on 2000-06-01. The following dates were fixed: - latest date by which the EN has to be implemented at national level by p
18、ublication of an identical national standard or by endorsement - latest date by which the national standards conflicting with the EN have to be withdrawn (dop) 2001-03-01 (dw) 2003-06-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given f
19、or information only. In this standard, annexes A and ZA are normative and annexes B and C are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 61223-3-4:2000 was approved by CENELEC as a European Standard without any modification. In the
20、official version, for Bibliography, the following note has to be added for the standards indicated: IEC 60601-2-32 NOTE: Harmonized as EN 60601-2-32:1994 (not modified). STD-BSI BS EN b1223-3-4-ENGL 2000 lb24bb9 OBB3Bb5 504 = Page 3 EN 61223-3-42000 CONTENTS Page INTRODUCTION 6 Clause 1 2 3 4 5 6 Sc
21、ope and object . 6 1.1 Scope 6 1.2 Object 6 7 Normative references . Terminology 7 3.1 Degree of requirements 7 3.2 Use of terms 8 3.3 Defined terms . 8 General aspects Of ACCEPTANCE TESTS . 8 4.1 General conditions to be considered in test procedures . 8 4.2 Documents and data for the tests 9 4.3 T
22、est conditions 9 4.4 Scope of tests 10 4.5 Test equipment including PHANTOMS and TEST DEVICES 10 4.6 Evaluating the test results . 12 Test methods for dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR . 12 5.1 Visual and functional tests 12 5.2 *X-RAY TUBE VOLTAGE 12 5.3 *TOTAL FILTRATION
23、. 13 5.4 *FOCAL SPOT of the X-RAY TUBE 13 5.5 5.6 FOCAL SPOT TO SKIN DISTANCE 14 5.7 *Reproducibility Of RADIATION OUTPUT . 15 5.8 LINE PAIR RESOLUTION 15 5.9 LOW CONTRAST RESOLUTION 15 Test methods for dental panoramic X-RAY EQUIPMENT with extra-orai X-RAY IMAGE RECEPTOR 16 6.1 Visual and functiona
24、l tests 16 6.2 X-RAY TUBE VOLTAGE 16 6.3 TOTAL FILTRATION 16 6.4 FOCAL SPOT of the X-RAY TUBE . 16 16 6.5 Limitation and alignment of the X-RAY BEAM . 6.6 FOCAL SPOT TO SKIN DISTANCE 17 6.7 Reproducibility Of RADIATION OUTPUT 17 6.8 LINE PAIR RESOLUTION 18 6.9 LOW CONTRAST RESOLUTION 18 6.10 RADIOGR
25、APHIC FILM Cassettes With INTENSIFYING SCREENS . 18 6.1 1 Image homogeneity 18 6.1 2 19 . . . . . Limitation and alignment of the X-RAY BEAM . 14 Indicators for patients positioning . 19 6.13 Panoramic layer O BSI 12-2000 STD.BSI BS EN 61223-3-4-ENGL 2000 E 1b24bb9 O8838bb 440 m Page 4 EN 6 1223-3-4
26、:2000 Clause Page 7 Test methods for dental cephalometric X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR 19 7.1 Visual and functional tests 19 7.2 X-RAY TUBE VOLTAGE 19 7.3 TOTAL FILTRATION 19 7.4 FOCAL SPOT of the X-RAY TUBE . 19 7.5 Limitation and alignment of the X-RAY BEAM . 19 7.6 FOCAL S
27、POT TO SKIN DISTANCE 20 7.7 Reproducibility of RADIATION OUTPUT 20 7.8 LINE PAIR RESOLUTION 20 7.9 LOW CONTRAST RESOLUTION 20 7.1 O RADIOGRAPHIC FILM cassettes with INTENSIFYING SCREENS . 20 Test report and statement of compliance 20 8 Annex A (normative) Terminology - Index of defined terms 29 Anne
28、x B (informative) Examples of requirements (accuracy, tolerances, discrepancies) according to actual IEC standards or state of the art . 31 Annex C (informative) ACCEPTANCE TEST for processing of non-screen dental X-ray films (non-screen film) 33 Bibliography . 34 Annex ZA (normative) Normative refe
29、rences to international publications with their corresponding European pu bl cations . .35 Figure I - Dental X-RAY EQUIPMENT With intra-Oral X-RAY IMAGE RECEPTOR measuring arrangement for AIR ERMA and resolution 22 Figure 2 - Dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR measuring arra
30、ngement for AIR ERMA and resolution 23 measuring arrangement for AIR KERMA and resolution . 24 Figure 4 - Example of a dental panoramic X-RAY EQUIPMENT with extra-oral digital X-RAY IMAGE RECEPTOR measuring arrangement for AIR KERMA, resolution, image homogenity and panoramic layer 25 Figure 5 - Exa
31、mple of a cephalometric X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR measuring arrangement for AIR KERMA and resolution 26 Figure 6 - Dental PHANTOM (example) 27 Figure 3 - Dental panoramic X-RAY EQUIPMENT with extra-orai X-RAY IMAGE RECEPTOR Figure 7 - Dental PHANTOM for digital image acqui
32、sition or processing parts (example) . 28 Table B.1 - Typical Values Of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES. 32 O BSI 12-2000 STD-BSI BS EN 61223-3-4-ENGL 2000 = Lb24bb9 0883Bb7 387 Page 6 EN 61223-3-4:2000 INTRODUCTION This part of IEC 61223 is part of a series of International Stan
33、dards which gives methods of acceptance testing and constancy testing for subsystems and systems (for example, diagnostic X-RAY EQUIPMENT) including film processing. Some provisions or statements in this standard require additional information. Such information is presented in annex B. An asterisk i
34、n the left margin of a clause or subclause indicates the presence of such additional information. O BSI 12-2000 STDaBSI BS EN bL223-3-4-ENGL 2000 = Lb24bb9 08838b8 2L3 E Page 6 EN 61223-3-4:2000 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - Part 3-4: Acceptance tests - Imaging perf
35、ormance of dental X-ray equipment 1 Scope and object 1.1 Scope This part of IEC 61223 applies to those components of dental XRAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose. This standard applies to the performance of the ACCEPTANCE TEST on dental
36、X-RAY EQUIPMENT With intra-oral X-RAY IMAGE RECEPTOR and dental X-RAY EQUIPMENT with extra-orai X-RAY IMAGE RECEPTOR (for example, dental panoramic X-RAY EQUIPMENT or cephalometric X-RAY). This standard applies to dental film and digital image acquisition and processing. 1.2 Object This standard def
37、ines a) the essential parameters which describe the performance of the above-mentioned dental b) methods of testing and whether measured quantities related to those parameters comply with the specified tolerances. X-RAY EQUIPMENT with regard to imaging properties and PATIENT dose; These methods rely
38、 mainly on non-invasive measurements, using appropriate test equipment, performed during or after the installation is completed. Signed statements covering steps in the installation procedure may be used as part of the acceptance testing. The aim is to verify compliance of the installation with spec
39、ifications affecting the image quality and PATIENT dose, and to detect malfunctions that are not in agreement with those specifications. This standard does not in itself specify tolerances for the parameters under investigation. Neither is it intended to consider c) aspects of mechanical and electri
40、cal safety; d) aspects of mechanical, electrical and software performance, unless they are essential to the performance of the tests directly affecting image quality and PATIENT dose. O BSI 12-2000 STD-BSI BS EN b3223-3-V-ENGL 2000 W Lb24bb7 08838b9 157 = Page 7 EN 61223-3-4:2000 2 Normative referen
41、ces The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IEC 61223. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part
42、of IEC 61223 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and IS0 maintain registers of currently valid Internati
43、onal Standards. IEC 60336:1993, X-ray tube assemblies for medical diagnosis - Characteristics of focal spots IEC 60417-1:1998, Graphical symbols for use on equipment - Part 7: Overview and application IEC 6041 7-2: 1998, Graphical symbols for use on equipment - Part 2: Symbol originals IEC 60522: 19
44、99, Determination of the permanent filtration of X-ray tube assemblies IEC 60601-1 :1988, Medical electrical equipment - Part I: General requirements for safety IEC 60601 -2-28: 1993, Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ra
45、y tube assemblies for medical diagnosis IEC 60788: 1984, Medical radiology - Terminology IEC 60878:1988, Graphical symbols for electrical equipment in medical practice IEC 61 223-1 :I 993, Evaluation and routine testing in medical imaging departments - Part 7: General aspects IEC 61267994, Medical d
46、iagnostic X-ray equipment - Radiation conditions for use in the determina tion of characteristics IS0 2092:1981, Light metals and their alloys - Code of designation based on chemical symb ols 3 Terminology 3.1 Degree of requirements In this standard, certain terms which are not printed in SMALL CAPI
47、TALS have particular meanings, as follows: - “shall“ indicates a requirement that is mandatory for compliance; - “should“ - “may“ - “specific“ indicates a strong recommendation that is not mandatory for compliance: indicates a permitted manner of complying with a requirement or of avoiding the need
48、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 indicate definitive information stated by the MANUFACTUR
49、ER in under consideration, usually concerning its intended purposes, or the para- meters or conditions associated with its use or with testing to determine com p I ia nce. ACCOMPANYING DOCUMENTS or in other documentation relating to the EQUIPMENT O BSI 12-2000 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions in IEC 60601-1, in IEC 60788, in IEC 61223-1, or in this standard. NOTE definition given in one of the publications listed above, a corresponding term is printed in lower-
