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1、INTERNATIONAL STANDARD IEC 61223-2-9 First edition 1999-09 Evaluation and routine testing in medical imaging departments Part 2-9: Constancy tests Equipment for indirect radioscopy and indirect radiography Essais dvaluation et de routine dans les services dimagerie mdicale Partie 2-9: Essais de cons
2、tance Dispositifs de radioscopie et de radiographie indirectes Reference number IEC 61223-2-9:1999(E) Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Space Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction
3、 or networking permitted without license from IHS -,-,- Numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. Consolidated publications Consolidated versions of some IEC publications including amendments are available. For example, edition numbers 1
4、.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Validity of this publication The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that
5、the content reflects current technology. Information relating to the date of the reconfirmation of the publication is available in the IEC catalogue. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publication, as wel
6、l as the list of publications issued, is to be found at the following IEC sources: IEC web site* Catalogue of IEC publications Published yearly with regular updates (On-line catalogue)* IEC Bulletin Available both at the IEC web site* and as a printed periodical Terminology, graphical and letter sym
7、bols For general terminology, readers are referred to IEC 60050: International Electrotechnical Vocabulary (IEV). For graphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred to publications IEC 60027: Letter symbols to be used in electrical technolog
8、y, IEC 60417: Graphical symbols for use on equipment. Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols for diagrams. * See web site address on title page. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marsha
9、ll Space Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD IEC 61223-2-9 First edition 1999-09 Evaluation and routine testing in medical imaging departments Part 2-9: Constancy tests Equipment
10、 for indirect radioscopy and indirect radiography Essais dvaluation et de routine dans les services dimagerie mdicale Partie 2-9: Essais de constance Dispositifs de radioscopie et de radiographie indirectes PRICE CODE IEC 1999 Copyright - all rights reserved No part of this publication may be reprod
11、uced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission3, rue de Varemb Geneva, Switzerland Telefax: +41 22 919 0300e-mail: inmailiec.ch IEC web site http
12、:/www.iec.ch L For price, see current catalogue Commission Electrotechnique Internationale International Electrotechnical Commission Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Space Flight Center/9972545001 Not for Resale, 03/07/2
13、007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 61223-2-9 IEC:1999(E) CONTENTS Page FOREWORD3 Clause 1Scope and object.5 1.1Scope.5 1.2Object.5 2Normative references.6 3Terminology.7 3.1Degree of requirements.7 3.2Use of terms.7 4General aspects of CONSTANCY
14、TESTS.7 4.1General conditions affecting test procedures.8 4.2Establishment of BASELINE VALUES.8 4.3Frequency of CONSTANCY TESTS.8 4.4Identification of equipment, instrumentation and test conditions.8 4.5Measured functional parameters.9 5Performance tests10 5.1RADIATION output from the X-RAY SOURCE A
15、SSEMBLY.10 5.2Grey-scale image and AUTOMATIC INTENSITY CONTROL.11 5.3Threshold contrast for detail of large size13 5.4Limiting resolution for detail of high contrast for X-RADIATION.13 5.5Frequency of CONSTANCY TESTS.14 6Statement of compliance15 Annex A (normative) Terminology Index of defined term
16、s.16 Annex B (informative) Example of a form for the standardized test report18 Annex C (informative) Guidance on action to be taken19 Annex D (normative) PHANTOMS and TEST DEVICES20 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Spac
17、e Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- 61223-2-9 IEC:1999(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS Part 2-9: Constancy tests Equipme
18、nt for indirect radioscopy and indirect radiography FOREWORD 1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-opera
19、tion on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt wit
20、h may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined b
21、y agreement between the two organizations. 2)The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees. 3)
22、The documents produced have the form of recommendations for international use and are published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. 4)In order to promote international unification, IEC National Committees undertake to
23、apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. 5)The IEC provides no marking procedure to in
24、dicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. The IEC shall not be held responsibl
25、e for identifying any or all such patent rights. International Standard IEC 61223-2-9 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this standard is based on the following documents: FDISRepor
26、t on voting 62B/371/FDIS62B/383/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 3. Annexes A and D form an integral part of this s
27、tandard. Annexes B and C are for information only. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Space Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -
28、,-,- 4 61223-2-9 IEC:1999(E) This standard forms part 2-9 of IEC 61223, which will include the following parts: Part 1:General aspects Part 2-1:Constancy tests Film processors Part 2-2:Constancy tests Radiographic cassettes and film changers Film-screen contact and relative sensitivity of the screen
29、-cassette assembly Part 2-3:Constancy tests Darkroom safelight conditions Part 2-4:Constancy tests Hard copy cameras Part 2-5:Constancy tests Image display devices Part 2-6:Constancy tests X-ray equipment for computed tomography Part 2-7:Constancy tests Equipment for intra-oral dental radiography ex
30、cluding dental panoramic equipment Part 2-9:Constancy tests Equipment for indirect radioscopy and indirect radiography Part 2-10: Constancy tests X-ray equipment for mammography Part 2-11: Constancy tests Equipment for general direct radiography The committee has decided that this publication remain
31、s valid until 2003. At this date, in accordance with the committees decision, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. A bilingual version of this standard may be issued at a later date. Copyright International Electrotechnical Commission Provided by
32、 IHS under license with IECLicensee=NASA Marshall Space Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- 61223-2-9 IEC:1999(E) 5 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS Part 2-9: Constancy tes
33、ts Equipment for indirect radioscopy and indirect radiography 1 Scope and object 1.1 Scope This part of IEC 61223 applies to those components of X-RAY EQUIPMENT which a) generate, influence the propagation of, and detect X-RADIATION, and b) process, present and store diagnostic X-ray images in RADIO
34、LOGICAL INSTALLATIONS with diagnostic X-ray systems for INDIRECT RADIOSCOPY and INDIRECT RADIOGRAPHY which use X- RAY IMAGE INTENSIFIERS in conjunction with analogue and/or digital storage systems: closed-circuit television display systems: cut film cameras cine cameras. This standard is a part of a
35、 series of Particular Publications (international standards and technical reports) which define methods of testing the constancy of operation of various sub- systems of diagnostic X-RAY EQUIPMENT. This standard gives methods of tests for the constancy of properties of diagnostic X-RAY EQUIPMENT as d
36、escribed in IEC 61223-1 (see clause 2). This part of IEC 61223 is designed to be applicable to equipment for indirect radioscopy and indirect radiography without digital imaging devices. 1.2 Object This standard defines the essential parameters which describe or affect the performance of the above c
37、omponents of X-RAY EQUIPMENT, and methods of checking that variations in measured quantities related to those parameters are within acceptable limits, in order to maintain adequate standards of imaging whilst reducing unnecessary IRRADIATION of the PATIENT. These methods are based upon assessment of
38、 radiological information using appropriate TEST DEVICES. The purpose of the methods is to establish a reference level of performance when such equipment is accepted; to detect or verify any significant variation in functional parameters which may then require corrective actions. Copyright Internati
39、onal Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Space Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 61223-2-9 IEC:1999(E) Because RADIOLOGICAL INSTALLATIONS differ
40、 widely from each other, it is not possible in this standard to specify target values and tolerances for the parameters which would be generally applicable as criteria of acceptable performance. Guidance is given, however, as to the degree of variation in single measurements which might require appr
41、opriate action. This standard is not intended to deal with aspects of mechanical and electrical safety; checks of the effectiveness of the direct means of protection against X-RADIATION; optimization of imaging performance. With regard to the measurements, reference is made to methods described in r
42、elated publications which, for practical reasons should be carried out prior to the application of the methods described in this standard (see clause 2). 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this p
43、art 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 of IEC 61223 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indi
44、cated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently valid International Standards. IEC 60788:1984, Medical radiology Terminology IEC 61223-1:1993, Evaluation and routine testing in medical imagi
45、ng departments Part 1: General aspects IEC 61223-2-1:1993, Evaluation and routine testing in medical imaging departments Part 2-1: Constancy tests Film processors IEC 61223-2-2:1993, Evaluation and routine testing in medical imaging departments Part 2-2: Constancy tests Radiographic cassettes and fi
46、lm changers Film-screen contact and relative sensitivity of the screen-cassette assembly IEC 61223-2-3:1993, Evaluation and routine testing in medical imaging departments Part 2-3: Constancy tests Darkroom safelight conditions IEC 61223-2-4:1994, Evaluation and routine testing in medical imaging dep
47、artments Part 2-4: Constancy tests Hard copy cameras IEC 61223-2-5:1994, Evaluation and routine testing in medical imaging departments Part 2-5: Constancy tests Image display devices Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=NASA Marshall Spac
48、e Flight Center/9972545001 Not for Resale, 03/07/2007 06:29:16 MSTNo reproduction or networking permitted without license from IHS -,-,- 61223-2-9 IEC:1999(E) 7 3 Terminology 3.1 Degree of requirements In this standard, certain terms (which are not printed in SMALL CAPITALS) have particular meanings, as follows: “shall“indicates a requirement that is mandatory for compliance; “should“indicates a strong re