BS EN 61223-3-1-1999 Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic syste.pdf

1、BRITISH STANDARD BS EN 61223-3-1:1999 IEC 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 radioscopic systems The European Standard EN 61223-3-1:1995 has the status of a British Stand

2、ard ICS 11.040.50BSEN61223-3-1:1999 This British Standard, having been prepared under the directionof the Health and Environment Sector Committee,was published underthe authorityof the Standards Committee and comesintoeffecton 15 August 1999 BSI 03-2000 ISBN 0 580 32753 1 National foreword This Brit

3、ish Standard is the English language version of EN61223-3-1:1999. It is identical with IEC61223-3-1:1999. The UK participation in its preparation was entrusted to Technical Committee CH/73, X-ray equipment, components, protection and utilization, which has the responsibility to: aid enquirers to und

4、erstand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented o

5、n this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number60000added to the old number. For instance, IEC27-1 has been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publicatio

6、ns 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. The British Standards which implement

7、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 not purport to include all the necess

8、ary 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 front cover, pagesi andii, theEN tit

9、le page, pages2 to 38 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN61223-3-1:1999 BSI 03-2000 i Co

10、ntents Page National foreword Inside front cover Foreword 2 Text of EN 61223-3-1 5ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61223-3-1 May 1999 ICS 11.040.50 English version Evaluation and routine testing in medical imaging departments Part 3-1: Acceptance tests Imaging performance

11、 of X-ray equipment for radiographic and radioscopic systems (IEC 61223-3-1:1999) 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 (CEI 61223-3-1:1999)

12、Bewertung und routinemige Prfung in Abteilungen fr medizinische Bildgebung Teil 3-1: Abnahmeprfungen Bildgebungsleistung der Rntgeneinrichtung bei radiographischen und Durchleuchtungs-Systemen (IEC 61223-3-1:1999) This European Standard was approved by CENELEC on1999-05-01. CENELEC members are bound

13、 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 such national standards may be obtained on application to the Cen

14、tral 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 language and notified to the Central Secretariat has the same s

15、tatus as the official 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 Euro

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

17、NELEC members. Ref. No. EN 61223-3-1:1999 EEN61223-3-1:1999 BSI 03-2000 2 Foreword The text of document 62B/361/FDIS, future edition1 of IEC61223-3-1, prepared by SC62B, Diagnostic imaging equipment, of IECTC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote

18、 and was approved by CENELEC as EN61223-3-1 on1999-05-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex A and Annex ZA are normative and Annex B, Annex C, A

19、nnex D and Annex E are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC61223-3-1:1999 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 Introduction 5 1 Scope and object 5 1.1 Scope 5 1.2 Ob

20、ject 5 2 Normative references 6 3 Terminology 6 3.1 Degree of requirements 6 3.2 Use of terms 6 3.3 Defined terms 7 4 General aspects of ACCEPTANCE TESTS 7 4.1 General conditions to be considered in test procedures 7 4.2 Documents and data for the tests 7 4.3 Test conditions 8 4.4 Test parameters 8

21、4.5 Test equipment including PHANTOMS (ATTENUATION devices) and TEST DEVICES 9 4.6 Evaluating the test results 10 5 Test methods for RADIOGRAPHY EQUIPMENT 10 5.1 Visual and functional tests 10 5.2 *X-RAY TUBE VOLTAGE 11 5.3 *TOTAL FILTRATION 11 5.4 *FOCAL SPOT of the X-RAY TUBE 11 5.5 *Limitation an

22、d indication of the extent of the X-RAY BEAM 12 5.6 *Linearity and reproducibility of TRANSMISSION KERMA or RADIATION OUTPUT 13 5.7 *ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 14 5.8 *AUTOMATIC EXPOSURE CONTROL (AEC) 14 5.9 LINE PAIR RESOLUTION for DIRECT RADIOGRA

23、PHY 16 5.10 *AIR KERMA area product indicator 16 6 Test methods for RADIOSCOPY EQUIPMENT 16 6.1 Visual and functional tests 16 6.2 X-RAY TUBE VOLTAGE 16 6.3 TOTAL FILTRATION 16 6.4 FOCAL SPOT of the X-RAY TUBE 17 6.5 Functioning of the AUTOMATIC EXPOSURE RATE CONTROL (AERC) 17 latest date by which t

24、he EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2000-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2002-05-01EN61223-3-1:1999 BSI 03-2000 3 Page 6.6 Limitation of the extent

25、of the X-RAY BEAM 17 6.7 ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 18 6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER for RADIOSCOPY 18 6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with X-RAY IMAGE INTENSIFIER 19 6.10 AIR KERMA at the ENTR

26、ANCE PLANE of the X-RAY IMAGE INTENSIFIER for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 19 6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 20 6.12 *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY IMA

27、GE INTENSIFIER and for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 20 6.13 *LOW CONTRAST RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 21 6.14 AIR KERMA area produ

28、ct indicator 22 7 Additional tests required for TOMOGRAPHY EQUIPMENT 22 7.1 *Requirements 22 7.2 Test method 22 8 Test report and statement of compliance 22 Annex A (normative) Terminology Index of defined terms 29 Annex B (informative) Test parameters, symbols and units 32 Annex C (informative) Exa

29、mples of low contrast TEST DEVICES 32 Annex D (informative) Examples of requirements (accuracy, tolerances, discrepancies) according to actual IEC standards or state of the art 33 Annex E (informative) Bibliography 36 Annex ZA (normative) Normative references to international publications with their

30、 corresponding European publications 38 Page Figure 1 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT for AIR KERMA measurements 24 Figure 2 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT to test geometry and resolutions 25 Figure 3 LINE PAIR RESOLUTION TEST DEVICE 26

31、Figure 4 TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE 27 Figure 5 Discrepancies in visual indication of the X-RAY FIELD 28 Figure 6 Discrepancies in covering the IMAGE RECEPTION AREA 28 Table B.1 Test parameters, symbols and units 32 Table D.1 Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL

32、 SPOT VALUES 33 Table D.2 Values for the discrepancy parameters X, Y and Z according to IEC 60601-1-3 34 Table D.3 Typical values for the TRANSMISSION KERMA index 34 Table D.4 Typical values for the ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 354 blankEN61223-3-1:1

33、999 BSI 03-2000 5 Introduction This standard is part of a series of International Standards which give methods of acceptance testing and constancy testing for subsystems and systems (for example diagnostic X-RAY EQUIPMENT), including film processing, used in medical imaging departments. Some provisi

34、ons or statements in this standard require additional information. Such information is presented inAnnex D. An asterisk in the left margin of a clause or subclause indicates the presence of such additional information. 1 Scope and object 1.1 Scope This part of IEC 61223 applies to those components o

35、f 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 EQUIPMENT in the ACCEPTANCE TEST on the following medical diagnostic X-RAY EQUIPMENT and ASSOCIATED E

36、QUIPMENT: radiography equipment, for example: stationary radiography EQUIPMENT; mobile radiography EQUIPMENT; skull radiography EQUIPMENT; lung radiography EQUIPMENT; TOMOGRAPHY EQUIPMENT excluding COMPUTED TOMOGRAPHY; radiography devices (SPOTFILM DEVICES) in RADIOSCOPY EQUIPMENT; angiography EQUIP

37、MENT (excluding DSA function); CINERADIOGRAPHY equipment; RADIOSCOPY EQUIPMENT, including: combined radiographic and radioscopic EQUIPMENT. This standard applies to the generation of X-RADIATION and ACCESSORIES of digital systems. It does not apply to any digital image acquisition or image processin

38、g parts of the above mentioned diagnostic X-RAY EQUIPMENT. NOTESince the characterization of digital detectors and image processing is still under development, this will be included in a later edition of this standard. This standard does not apply to mammographic X-RAY EQUIPMENT, RADIOTHERAPY simula

39、tors, 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; b) methods of testing whether measured quantities related to those parameters comply with the specified toler

40、ances. These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during or after the installation is completed. Signed statements covering steps of product testing at the MANUFACTURERS site or during the installation procedure can be used as part of the acce

41、ptance testing. The aim is to verify compliance of the installation with specifications relating to the image quality and PATIENT dose, and to detect malfunctions that are not in agreement with those specifications. This standard does not specify tolerances for the parameters under investigation. No

42、r does it consider: c) aspects of mechanical and electrical 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.EN61223-3-1:1999 6 BSI 03-2000 2 Normative references The foll

43、owing normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Internationa

44、l Standard 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 ISO maintain registers of currently valid Internation

45、al 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 1: Overview and application. IEC 60522:1976, Inherent filtration of an X-ray tube assembly. IEC 60580:1977, Area exposure product me

46、ter. IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety. IEC 60601-1-3:1994, Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment. IEC 60601-2-7:199

47、8, Medical electrical equipment Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators. IEC 60601-2-28:1993, Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical

48、diagnosis. IEC 60788:1984, Medical radiology Terminology. IEC 60878:1988, Graphical symbols for electrical equipment in medical practice. IEC 61223-1:1993, Evaluation and routine testing in medical imaging departments Part 1: General aspects. IEC 61267:1994, Medical diagnostic X-ray equipment Radiat

49、ion conditions for use in the determination of characteristics. ISO 2092:1981, Light metals and their alloys Code of designation based on chemical symbols. 3 Terminology 3.1 Degree of requirements In this standard, certain terms which are not printed in SMALL CAPITALS have particular meanings, as follows: 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used as defined in IEC60601-1, IEC60788, IEC61223-1 and in3.3 of this standard (seeAnnex A) NOTEAtt