1、BRITISH STANDARD BS EN 61223-2-5:1995 BS7725-2.5: 1995 IEC1223-2-5: 1994 Evaluation and routine testing in medical imaging departments Part 2: Constancy tests Section 2.5 Method for image display devices The European Standard EN61223-2-5:1994 has the status of a BritishStandard UDC 615.84:778.2:620.
2、1BSEN61223-2-5:1995 This BritishStandard, having been prepared under the directionof the Sector Board forHealth and Environment, waspublished under the authorityofthe Standards Boardand comesinto effect on 15February1995 BSI 01-2000 The following BSI references relate to the work on this standard: C
3、ommittee reference HCC/73 Draft for comment 93/504903 DC ISBN 0 580 23748 6 Committees responsible for this BritishStandard The preparation of this BritishStandard was entrusted to Technical Committee HCC/73, Interchangeable X-ray components, upon which the following bodies were represented: British
4、 Institute of Radiology College of Radiographers Department of Health Institute of Physical Sciences in Medicine (IPSM) Royal College of Radiologists Society of X-ray Technology Amendments issued since publication Amd. No. Date CommentsBSEN61223-2-5:1995 BSI 01-2000 i Contents Page Committees respon
5、sible Inside front cover National foreword ii Foreword 2 Text of EN 61223-2-5 3 List of references Inside back coverBSEN61223-2-5:1995 ii BSI 01-2000 National foreword This BritishStandard has been prepared by Technical Committee HCC/73, Interchangeable X-ray components, and is the English language
6、version of EN61223-2-5:1994 Evaluation and routine testing in medical imaging departments Part2-5: Constancy tests Image display devices, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC1223-2-5:1994 published by the International Electrote
7、chnical Commission (IEC). 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 itself confer immunity from legal obligations. Cross-reference
8、s Publication referred to Corresponding BritishStandard IEC788:1984 BS6641:1985 Glossary of medical radiology terms BS7725 Evaluation and routine testing in medical imaging departments IEC1223-1:1993 Part1:1994 General Part2 Constancy tests IEC1223-2-1:1993 Section2.1:1994 Method for film processors
9、 IEC1223-2-2:1993 Section2.2:1994 Method for radiographic cassettes and film changers and film-screen contact and relative sensitivity of the screen-cassette assembly IEC1223-2-3:1993 Section2.3:1994 Method for darkroom safelight conditions IEC1223-2-4:1994 Section2.4:1994 Method for hard copy camer
10、as Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theEN title page, pages2 to22, an inside back cover 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
11、table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61223-2-5 June 1994 UDC 615.84:778.2:620.1 Descriptors: Electromedical equipment, computed tomography, medical imaging, constancy test, evaluation testing, routine testing English version Evaluation and routine test
12、ing in medical imaging departments Part2-5: Constancy tests Image display devices (IEC1223-2-5:1994) Essais dvaluation et de routine dans les services dimagerie mdicale Partie2-5: Essais de constance Dispositifsdevisualisation des images (CEI1223-2-5:1994) Bewertung und routinemige Prfung in Abteilu
13、ngen fr medizinische Bildgebung Teil2-5: Konstanzprfungen Bildwiedergabegerte (Monitore) (IEC1223-2-5:1994) This European Standard was approved by CENELEC on1994-03-08. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europe
14、an 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 Secretariat or to any CENELEC member. This European Standard exists in three official versions (Engli
15、sh, 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 official versions. CENELEC members are the national electrotechnical committees of Austria, B
16、elgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr
17、Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1994 Copyright reserved to all CENELEC members Ref. No. EN61223-2-5:1994 EEN61223-2-5:1994 2 BSI 01-2000 Foreword The text of document62B(CO)106, as prepared by Sub-Committee62B, Diagnostic imaging equipment, of IEC T
18、echnical Committee62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote in May1993. The reference document was approved by CENELEC as EN61223-2-5 on8 March1994. The following dates were fixed: Annexes designated “normative” are part of the body of the standard.
19、 Annexes designated “informative” are given only for information. In this standard, Annex A and Annex ZA are normative andAnnex B,Annex C,Annex D,Annex E andAnnex F are informative. Contents Page Foreword 2 Introduction 3 1 Scope and object 3 1.1 Scope 3 1.2 Object 3 2 Normative references 3 3 Termi
20、nology 4 3.1 Degree of requirements 4 3.2 Use of terms 4 3.3 Definitions 4 4 General aspects of CONSTANCY TESTS 4 4.1 General conditions affecting test procedures 4 4.2 Establishment of BASELINE VALUES 5 4.3 Frequency of CONSTANCY TESTS 5 4.4 Identification of equipment, instrumentation and test con
21、ditions 5 4.5 Measured functional parameters 5 5 Test methods 5 5.1 Summary 5 5.2 Test equipment 5 5.3 Test procedure 6 5.4 Data evaluation 9 Page 5.5 Criteria to be applied 9 5.6 Test report 10 5.7 Action to be taken 10 5.8 Frequency of testing 10 6 Statement of compliance 10 Annex A (normative) Te
22、rminology Index ofterms 17 Annex B (informative) Example of a form forthestandardized test report 18 Annex C (informative) Guidance on action tobetaken 20 Annex D (informative) Rationale 20 Annex E (informative) Bibliography Referencetest pattern 21 Annex F (informative) IMAGE DISPLAY DEVICES inwork
23、stations: Environmental conditions 22 Annex ZA (normative) Other international publications quoted in this standard with thereferences of the relevant European publications 22 Figure 1 Schematic representation of a testpattern used to check the constancy with respect to grey-scale reproduction 11 Fi
24、gure 2 Schematic representation of a testpattern used to check the constancy with respect to geometry and line structure 12 Figure 3 Schematic representation of a crosshatched pattern used to carry out measurements with respect to geometry 13 Figure 4 Schematic representation of a testpattern used t
25、o check the constancy with respect to resolution 14 Figure 5 Schematic representation of a testpattern used to check the constancy with respect to colour-related aspects 15 Figure 6 Preventive measures to establish optimal working conditions in workstations 16 latest date of publication ofan identic
26、al national standard (dop)1995-03-01 latest date of withdrawal ofconflicting national standards (dow)2000-03-01EN61223-2-5:1994 BSI 01-2000 3 Introduction Some provisions or statements in the body of this part of IEC1223 require additional information. Such information is presented inAnnex D, Ration
27、ale. 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 IEC1223 applies to IMAGE DISPLAY DEVICES as used in diagnostic imaging systems such as: digital radiography; digital subtraction angiography;
28、COMPUTED TOMOGRAPHY; magnetic resonance imaging; ultrasonic diagnostic equipment; NUCLEAR MEDICINE. *The test methods are based on the use of test patterns. *This standard does not apply to video monitors used in INDIRECT RADIOSCOPY systems. This standard is a part of a series of Particular Publicat
29、ions (standards and technical reports) which give methods of tests for the constancy of properties of diagnostic imaging systems as described in IEC1223-1 (see clause2). 1.2 Object* This part of IEC1223 defines: a) the functional parameters which describe or affect the performance of the above compo
30、nents of diagnostic imaging systems; and b) 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, in the case of X-RAY EQUIPMENT, avoiding unnecessary IRRADIATION of the PATIENT.
31、 The methods are based upon assessments of representations of appropriate test pattern. The aims are: to establish a reference level of performance when equipment is accepted; to detect and verify any significant variation in performance which may require corrective action. In some cases, reference
32、is made to procedures, described in other related publications, which for practical reasons are carried out prior to the application of the procedures described in this standard (see clause2). Because RADIOLOGICAL INSTALLATIONS differ widely from each other, this standard does not specify values and
33、 tolerances for the parameters which are generally applicable as criteria of acceptable performance. However, guidance is given to indicate the degree of variation in single measurements which might require appropriate action. This standard does not deal with: a) aspects of mechanical and electrical
34、 safety; b) optimization of imaging performance. *This part of IEC1223 describes a method to check, in terms of functional parameters, the constancy of the quality of images reproduced by IMAGE DISPLAY DEVICES in order to ensure that the required conditions for displaying images of consistent qualit
35、y are maintained, after the calibration and adjustment have been carried out. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IEC1223. At the time of publication, the editions indicated were vali
36、d. All normative documents are subject to revision, and parties to agreements based on this part of IEC1223 are encouraged to investigate the possibility of applying the most recent editions of the normative documents listed below. Members of IEC and ISO maintain registers of currently valid Interna
37、tional Standards. IEC788:1984, Medical radiology Terminology. IEC1223-1:1993, Evaluation and routine testing in medical imaging departments Part1: General aspects. IEC1223-2-1:1993, Evaluation and routine testing in medical imaging departments Part2-1: Constancy tests Film processors. IEC1223-2-2:19
38、93, Evaluation and routine testing in medical imaging departments Part2-2: Constancy tests Radiographic cassettes and film changers Film-screen contact and relative sensitivity of the screen-cassette assembly. IEC1223-2-3:1993, Evaluation and routine testing in medical imaging departments Part2-3: C
39、onstancy tests Darkroom safelight conditions. IEC1223-2-4:1994, Evaluation and routine testing in medical imaging departments Part2-4: Constancy tests Hard copy cameras. IEC1223-2-12:19XX, Evaluation and routine testing in medical imaging departments Part2-12: Constancy tests Film illuminators. (und
40、er consideration)EN61223-2-5:1994 4 BSI 01-2000 3 Terminology 3.1 Degree of requirements In this part of IEC1223 the verbal form: The term 3.2 Use of terms In this part of IEC1223, terms printed in SMALL CAPITALS are used as defined in IEC788,3.3 of this standard or other IEC publications referenced
41、 inAnnex A. Where a defined term is used as a qualifier in another defined or undefined term it is not printed in capital letters, unless the concept thus qualified is defined, or recognized as a derived term without definition. NOTEAttention is drawn to the fact that, in cases where the concept add
42、ressed is not strongly confined to the definition given in one of the publications listed above, a corresponding term is printed in lower-case letters. 3.3 Definitions 3.3.1 IMAGE DISPLAY DEVICE device capable of displaying images from an input signal provided by an imaging system NOTEDefinition fro
43、m IEC1223-2-4: HARD COPY CAMERA: Device producing non-erasable images on a sheet of material from an input signal provided by an imaging system. 4 General aspects of CONSTANCY TESTS For diagnostic imaging systems every link in the imaging chain may limit or degrade the image quality of the system. T
44、his holds especially for HARD COPY CAMERAS and IMAGE DISPLAY DEVICES. *If the HARD COPY CAMERA and IMAGE DISPLAY DEVICE are properly adjusted and maintained (seeclause2) both should consistently produce images that appear similar. The methods for testing the constancy described in this standard are
45、intended to enable the OPERATOR to detect changes in image quality of images produced by IMAGE DISPLAY DEVICES. For the results of the CONSTANCY TESTS described in this standard to be valid, it is essential to ensure that they are not significantly influenced by anything other than changes in the pa
46、rameters under test. In particular, attention shall be paid to darkroom safelight conditions and proper film processing (seeIEC1223-2-3, reference in clause2). Special attention should also be paid to ambient lighting conditions, when using FILM ILLUMINATORS (see1223-2-12, reference in clause2). Car
47、eful consideration shall be given to the operating and test conditions, under which the equipment is checked, including environmental influences. All equipment under test or used for testing shall be marked in order to permit easy identification as those items are used in the initial CONSTANCY TEST
48、and to assist in ensuring that the same items are used subsequently in related CONSTANCY TESTS. Prior to testing, the constancy of all equipment that is used for CONSTANCY TESTS shall be checked. 4.1 General conditions affecting test procedures The CONSTANCY TESTS described in this standard have bee
49、n designed to be robust, that is, their results should be affected only by changes in the parameters under investigation. The range of TEST DEVICES and test equipment has been kept to a minimum and restricted where possible to devices that are passive, inherently simple or reasonably stable. However, it is important: to consider the influence of environmental changes, particularly variations in supply voltage, on the results; to use photographic film which is handled, processed and viewed in accordance with t
