EN 61223-3-5-2004 en Evaluation and routine testing in medical imaging departments Part 3-5 Acceptance tests Imaging performance of computed tomography X-ray equipment《医疗成像部门评定和常规检.pdf

1、BRITISH STANDARD BS EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments Part 3-5: Acceptance tests Imaging performance of computed tomography X-ray equipment The European Standard EN 61223-3-5:2004 has the status of a British Standard ICS 11.040.50 BS EN 61223-3-5:2004 Th

2、is British Standard was published under the authority of the Standards Policy and Strategy Committee on 12 November 2004 BSI 12 November 2004 ISBN 0 580 44750 2 National foreword This British Standard is the official English language version of EN 61223-3-5:2004. It is identical with IEC 61223-3-5:2

3、004. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/2, Diagnostic imaging equipment, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on r

4、equest to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BS

5、I Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquire

6、rs to understand 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. Summary of pages This docume

7、nt comprises a front cover, an inside front cover, the EN title page, pages 2 to 33 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 61223-3-5 NORME EUROPE

8、NNE EUROPISCHE NORM September 2004 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2004 CENELEC - All rights of exploitation in

9、any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61223-3-5:2004 E ICS 11.040.50 English version Evaluation and routine testing in medical imaging departments Part 3-5: Acceptance tests Imaging performance of computed tomography X-ray equipment (IEC 61223-3-5:2004) Essais

10、 dvaluation et de routine dans les services dimagerie mdicale Partie 3-5: Essais dacceptation Performance dimagerie des quipements de tomodensitomtrie rayonnement X (CEI 61223-3-5:2004) Bewertung und routinemige Prfung in Abteilungen fr medizinische Bildgebung Teil 3-5: Abnahmeprfungen Leistungsmerk

11、male zur Bildgebung von Rntgeneinrichtungen fr Computertomographie (IEC 61223-3-5:2004) This European Standard was approved by CENELEC on 2004-09-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the sta

12、tus 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 Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German)

13、. 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 official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Cze

14、ch Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Foreword The text of document 62B/525/FDIS, future editio

15、n 1 of IEC 61223-3-5, 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 61223-3-5 on 2004-09-01. The following dates were fixed: latest date by which the EN has to

16、 be implemented at national level by publication of an identical national standard or by endorsement (dop) 2005-06-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2007-09-01 In this standard, the following print types are used: requirements, complian

17、ce with which can be tested, and definitions: in roman type; explanations, advice, notes, general statements, exceptions and references: in smaller type; test specifications: in italic type; TERMS DEFINED IN EN 60601-1, EN 60788, EN 61223-1 OR IN OTHER STANDARDS REFERENCED IN ANNEX A: SMALL CAPITALS

18、. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61223-3-5:2004 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: I

19、EC 61223-2-4 NOTE Harmonized as EN 61223-2-4:1994 (not modified). IEC 61223-2-6 NOTE Harmonized as EN 61223-2-6:1994 (not modified). IEC 60336 NOTE Harmonized as EN 60336:1995 (not modified). IEC 60522 NOTE Harmonized as EN 60522:1999 (not modified). IEC 60601-2-28 NOTE Harmonized as EN 60601-2-28:1

20、993 (not modified). IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified). IEC 61267 NOTE Harmonized as EN 61267:1994 (not modified). _ Page2 EN6122335:2004 CONTENTS INTRODUCTION.4 1 Scope and object5 2 Normative references.5 3 Terms and definitions .6 4 General aspects of ACCEPTANCE T

21、ESTS11 4.1 General conditions to be considered in test procedures.11 4.2 Documents and data for the tests 11 4.3 Identification of EQUIPMENT, instrumentation and test conditions 11 4.4 Scope of tests .12 4.5 Test EQUIPMENT, including PHANTOMS and TEST DEVICES.12 5 Test methods for CT SCANNERS.13 5.1

22、 Positioning of the PATIENT SUPPORT13 5.2 PATIENT positioning accuracy.14 5.3 TOMOGRAPHIC SECTION THICKNESS 16 5.4 Dose.17 5.5 NOISE, MEAN CT NUMBER and UNIFORMITY18 5.6 SPATIAL RESOLUTION.20 Annex A (normative) Terminology Index of defined terms21 Annex B (informative) Recommended criteria for test

23、 results .23 Annex C (informative) Visual Method for LOW CONTRAST RESOLUTION24 Annex D (informative) Accuracy of the gantry tilt25 Annex E (informative) DOSE PROFILE 26 Annex F (informative) Alternate test methods for SPATIAL RESOLUTION 27 Annex G (informative) TOMOGRAPHIC SECTION THICKNESS for heli

24、cal scanning.30 Annex ZA (normative) Normative references to international publications with their corresponding European publications .31 Bibliography32 Figure 1 Coordinate system .9 Table 1 Test pattern for dose.18 Table F.1 Comparison of SPATIAL RESOLUTION test procedures .27 Page3 EN6122335:2004

25、 INTRODUCTION This International Standard forms part of the IEC 61223 series, which gives methods of acceptance testing and constancy testing for medical diagnostic X-RAY EQUIPMENT. The ACCEPTANCE TEST is carried out after new EQUIPMENT has been installed, or major modifications have been made to ex

26、isting EQUIPMENT, in order to facilitate verification of applicable safety and performance standards, regulations, and contractual specifications which influence the image quality, PATIENT dose and positioning. To maintain the homogeneity of this IEC standard with the other two IEC standards address

27、ing CT SCANNERS, the measuring methods and the terminology are taken as applicable from the CT safety standard IEC 60601-2-44, and the CT constancy testing standard IEC 61223-2-6 3 1)Some provisions or statements in this standard require additional information. Additional information is presented in

28、 the annexes. An asterisk in the left margin of a clause or subclause indicates the presence of such additional information. 1)Figures in square brackets refer to the bibliography. Page4 EN6122335:2004 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS Part 3-5: Acceptance tests Imaging p

29、erformance of computed tomography X-ray equipment 1 Scope and object This part of IEC 61223 applies to those components of CT SCANNERS which influence the image quality, PATIENT dose and positioning. This standard defines the essential parameters which describe the performance of the CT SCANNERS wit

30、h regard to image quality, PATIENT dose and positioning; the list of parameters to be tested can be found in section 4.4. defines the methods of testing the essential parameters; evaluates compliance with the tolerances of the parameters specified by the ACCOMPANYING DOCUMENTS. These methods rely ma

31、inly on non-invasive measurements, using appropriate test EQUIPMENT, performed during the installation or after it has been completed. Signed statements covering steps in the installation procedure may be used as part of the ACCEPTANCE TEST report. This part of IEC 61223 is intended to assist in per

32、forming the ACCEPTANCE TESTS on a CT SCANNER The aim is to verify compliance of the installation with specifications affecting the image quality, PATIENT dose and positioning. It is not intended to consider: aspects of mechanical and electrical safety; aspects of mechanical, electrical and software

33、performance, unless they are essential for performing the ACCEPTANCE TESTS and are directly affecting image quality, PATIENT dose and positioning. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition

34、cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety 2)IEC 60601-2-44:2001, Medical electrical equipment Part 2-44: Particular requirements for the sa

35、fety of X-ray equipment for computed tomography 3)Amendment 1 (2002) IEC 60788, Medical electrical equipment Glossary of defined terms 2) The new edition of IEC 60601-1 (to be published) will be entitled: Medical electrical equipment Part 1: General requirements for basic safety and essential perfor

36、mance3) There exists a consolidated edition 2.1 (2002) including Edition 2 (2001) and its Amendment 1 (2002) Page5 EN6122335:2004 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE 1 In this standard, terms printed in SMALL CAPITALS are used in

37、 accordance with their definitions in the General Standard or in IEC 60788. NOTE 2 Attention is drawn to the fact that in cases where the concept addressed is not strongly confined to the definition given in one of the publications listed above, a corresponding term is printed in lower case letters.

38、 NOTE 3 An index of defined terms used in this standard is given in Annex A. NOTE 4 Associated conditions qualifying the usage of certain terms are given below. 3.1 ACCEPTANCE TEST test carried out after new EQUIPMENT has been installed, or major modifications have been made to existing EQUIPMENT, i

39、n order to verify compliance with contractual specifications IEC 61223-1:1993, definition 3.2.4 1 3.2 CONSTANCY TEST each of a series of tests carried out to ensure that the functional performance of EQUIPMENT meets established criteria; or to enable the early recognition of changes in the propertie

40、s of components of the EQUIPMENT IEC 61223-1:1993, definition 3.2.6 3.3 CT CONDITIONS OF OPERATION all selectable parameters governing the operation of a CT SCANNER, for example NOMINAL TOMOGRAPHIC SECTION THICKNESS, CT PITCH FACTOR, filtration, peak X-RAY TUBE VOLTAGE and either X-RAY TUBE CURRENT

41、and LOADING TIME or CURRENT TIME PRODUCT IEC 60601-2-44, definition 2.102 3.4 CT SCANNER X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT) diagnostic X-ray system intended to generate cross-sectional images of the body by computer reconstruction of X-ray transmission data obtained at different angles. Th

42、is generic type of device may include signal analysis and display EQUIPMENT, PATIENT SUPPORT, support parts and ACCESSORIES NOTE Secondary imaging processing is not included in the scope of this standard. IEC 60601-2-44, definition 2.101 3.5 COMPUTED TOMOGRAPHY DOSE INDEX 100 CTDI 100integral of the

43、 DOSE PROFILE produced in a single axial scan along a line perpendicular to the TOMOGRAPHIC PLANE from 50 mm to +50 mm, divided by the product of the number of TOMOGRAPHIC SECTIONS N and the NOMINAL TOMOGRAPHIC SECTION THICKNESS T Page6 EN6122335:2004 dz T N z D= CTDI ) (mm +50 mm 50 - 100where D(z)

44、 is the DOSE PROFILE along a line z perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as absorbed dose to air; N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray source; T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS. NOTE 1 The term CTDI 100has been in

45、troduced as a more representative value for dose than the traditional CTDI integrated from 7 T to +7 T as defined by the FDA in 21 CFR 1020.33 4) . NOTE 2 The dose is reported as absorbed dose to air. This is required in order to avoid present confusion, as some MANUFACTURERS of CT SCANNERS express

46、dose values calculated as absorbed dose to air and others as absorbed dose to polymethyl-methacrylate (PMMA). Although CTDI 100refers to absorbed dose to air, for practical purposes the evaluation of absorbed dose to air within a PMMA dosimetry PHANTOM is well approximated by measurement of the air

47、kerma with an lionization chamber in the PHANTOM. NOTE 3 This definition assumes that the DOSE PROFILE is centred on z = 0. NOTE 4 A single axial scan is typically a 360 rotation of the X-ray source. IEC 60601-2-44, definition 2.106 3.6 WEIGHTED CTDI 100 weighted CTDI (CTDI w ) defined as ) eral 100

48、(periph ) 00(centre 1 W 3 2 3 1 CTDI CTDI CTDI + = where CTDI 100(centre) is the value measured in the centre of the test object, and CTDI 100(peripheral) is the average value measured in the periphery of the test object. 3.7 COMPUTED TOMOGRAPHY NUMBER CT NUMBER number used to represent the mean X-r

49、ay ATTENUATION associated with each elemental area of the COMPUTED TOMOGRAPHY image NOTE The CT NUMBER is normally expressed in Hounsfield units. MEASURED VALUES of the linear ATTENUATION coefficients are transformed into CT NUMBERS using the international Hounsfield scale, using the expression: CT NUMBER of material 000 1 water water material = where