1、Evaluation and routine testing in medical imaging departments Part 2. Constancy tests Section 2.5 Method for image display devices The European Standard EN 61223-2-5 : 1994 has the status of a British Standard CDC 615.84 : 778.2 : 620.1 BS EN BS 7725 : section 2.5 : 1995 1994 81223-2-5 : 1995 CEC 12
2、23-2-5 : 3404589 0083079 677 M BS EN 61223-2-5 : 1995 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Rchnical Committee HCC/73, Interchangeable X-ray components, upon which the following bodies were represented: British Institute of Radiolo
3、gy College of Radiographers Department of Health Institute of Physical Sciences in Medicine (IPSM) Royal College of Radiologists Society of X-ray Tkchnology This Biitish Standard, having been prepared under the direction of the Sector Board for Health and Environment, was published under the authori
4、ty of the Standards Board and comes into effect on 15 Februaiy 1995 O BSI 1995 Amendments issued since publication Amde No* I Date I lkxt affected The following BSI references relate to the work on this standard: Committee reference HCC/73 Draft for comment 93/504903 DC ISBN O 680 23748 6 - W 340458
5、9 0083080 309 = BS EN 61223-2-5 : 1995 National foreword This British Standard has been prepared by Technical Committee HCCi73, Interchangeable X-ray components, and is the English language version of Eh 61223-2-5 : 1994 Evaluation und rotitim? testing in medical imnugirig ckpctrtrrients Pctrt 2-5:
6、Comtarzcy tests - Image display devices, published by the European Committee for Electrotechiucal Standarclization (CENELEC). It is identical with IEC 1223-2-5 : 1994 published by the International Electrotechnical Commission (IEC). Cross-references IEC 788 : 1984 Publication referred to Correspondi
7、ng British Standard BS 6641 : 1985 Glossa?.g/ of rrzedicul ucliology term BS 7725 Eualtmtiorz. cml rcnctirie testing in medicul irrzuging clepartrrwnts Part 1 : 1994 Genercd Pai- 2 Constancg tests Section 2.1 : 1994 Method for fihriprocessors Section 2.2 : 1994 iMethocl for rcccl!ogmphic cassettes c
8、crid film chmgers arid filrn-screen contact arid relative sensitivity of the screerzicussette ussewhly Section 2.3 : 1994 Method for clrcrkroorn sufelight conditions Section 2.4 : 1994 Methoclfor /14tt-Cl cop3 currrcis IEC 1223-1 : 1993 IEC 1223-2-1 : 1993 IEC 1223-2-2 : 1993 . IEC 1223-2-3 : 1993 I
9、EC 1223-2-4 : 1994 Compliance with a British Standard does not of itself confer immunity from legal obligations. i 3404589 0083081 245 EUROPEAN STANDARD EN 61223-2-5 NORME EUROPENNE EUROPISCHE NORM June 1994 UDC 615.84:778.2:620.1 Descriptors: Electromedical equipment, computed tomography, medical i
10、maging, constancy test, evaluation testing, routine testing English version Evaluation and routine testing in medical imaging departments Part 2-5: Constancy tests - Image display devices (IEC 1223-2-5 : 1994) Essais dvaluation et de routine dans les services dimagerie mdicale Partie 2-5: Essais de
11、constance Dispositifs de visualisation des images (CE1 1223-2-5 1994) (Monitore) Bewertung und routinemoige Prfung in Abteilungen fr medizinische Bildgebung Ri1 2-5: Konstanzprfungen Bild wiedergabegerte (IEC 1223-2-5 : 1994) This European Standard was approved by CENELEC on 1994-03-08. CENELEC memb
12、ers are bound to comply with the CENXENELEC 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 applicatio
13、n 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 its own language and notified to the Central Secretariat ha
14、s the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European
15、 Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels O 1994 Copyright reserved to CENELEC members Ref. No. EN 61223-2-5 : 1994 E m 3404589 0083082 L8L
16、Page 2 EN 61223-2-5 : 1994 Foreword The text of document 62B(C0)106, as prepared by Sub-committee 62B, Diagnostic imaging equipment, of IEC Technical Committee 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote in May 1993. The reference document was approve
17、d by CENELEC as EN 61223-2-5 on 8 March 1994. The following dates were fixed: - latest date of publication of an identical national standard (dop) 1995-03-01 - latest date of withdrawal of conflicting national standards (dow) 2000-03-01 Annexes designated normative are part of the body of the standa
18、rd. Annexes designated informative are given only for information. In this standard, annexes A and ZA are normative and annexes B, C, D, E and F are informative. Page 3 EN 61223-2-5 : 1994 CONTENTS Page INTRODUCTION 5 . Clause Scope and object 1 . 1 Scope . 1.2 Object Normative references . Terminol
19、ogy . 3.1 Degree of requirements . 3.2 Use of terms . 3.3 Definitions . General aspects Of CONSTANCY TESTS 4.1 General conditions affecting test procedures . 4.2 4.3 4.4 Identification of equipment. instrumentation and test conditions . 4.5 Measured functional parameters Test met hods 5.1 Summary .
20、5.2 Test equipment . 5.3 Test procedure . 5.4 Data evaluation 5.5 Criteria to be applied . 5.6 Test report . 5.7 Action to be taken 5.8 Frequency of testing Statement of compliance . Establishment of BASELINE VALUES . Frequency Of CONSTANCY TESTS . 6 6 6 7 8 8 8 8 8 9 9 9 10 10 10 10 10 12 17 18 18
21、18 19 19 Figures 1 Schematic representation of a test pattern used to check the constancy with respect to grey-scale reproduction . 20 Schematic representation of a test pattern used to check the constancy 2 with respect to geometry and line structure 21 Page 4 EN 61223-2-5 : 1994 3 4 Schematic repr
22、esentation of a crosshatched pattern used to carry out measurements with respect to geometry . 22 Schematic representation of a test pattern used to check the constancy with respect to resolution Schematic representation of a test pattern used to check the constancy with respect to colour-related as
23、pects . 24 Preventive measures to establish optimal working conditions in workstations 25 23 5 6 Annexes 20 A Terminology - Index of terms . B Example of a form for the standardized test report 28 C Guidance on action to be taken 31 D Rationale . 32 E Bibliography - Reference test pattern . 34 F IMA
24、GE DISPLAY DEVICES in workstations: Environmental conditions 35 ZA (normative) Other international publications quoted in this standard with the references of the relevant European publications . . . 36 Page 5 EN 61223-2-5 : 1994 INTRODUCTION Some provisions or statements in the body of this part of
25、 IEC 1223 require additional information. Such information is presented in annex D, Rationale. An asterisk in the left margin of a clause or subclause indicates the presence of such additional information. Page 6 EN 61223-2-5 : 1994 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - Par
26、t 2-5: Constancy tests - Image display devices 1 Scope and object 1.1 Scope systems such as: This part Of IEC 1223 applies to IMAGE DISPLAY DEVICES as used in diagnostic imaging - digital radiography; - digital subtraction angiography; - magnetic resonance imaging; - ultrasonic diagnostic equipment;
27、 - COMPUTED TOMOGRAPHY; - 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 pari of a series of Particular Publications (standards and technical reports) which give method
28、s of tests for the constancy of properties of diagnostic imaging systems as described in IEC 1223-1 (see clause 2). *1.2 Object This pari of IEC 1223 defines: a) the functional parameters which describe or affect the performance of the above components of diagnostic imaging systems; and b) methods o
29、f 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. The methods are based upon assessments of representa
30、tions 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 correct ive action. Page 7 EN 61223-2-5 : 1994 In some cases, reference is made to procedures
31、, described in other related publications, which for practical reasons are carried out prior to the application of the procedures described in this standard (see clause 2). Because RADIOLOGICAL INSTALLATIONS differ widely from each other, this standard does not specify values and tolerances for the
32、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 safety; b) optimiza
33、tion of imaging performance. This part of IEC 1223 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 quality are maintained, af
34、ter 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 pari of IEC 1223. At the time of publication, the editions indicated were valid. All normative do
35、cuments are subject to revision, and parties to agreements based on this pari of IEC 1223 are encouraged to investigate the possibility of applying the most recent editions of the normative documents listed below. Members of IEC and IS0 maintain registers of currently valid International Standards.
36、IEC 788: 1984, Medical radiology - Terminology IEC 1223-1 : 1993, Evaluation and routine testing in medical imaging departments - Part I: General aspects IEC 1223-2-1 : 1993, Evaluation and routine testing in medical imaging departments - Part 2- 1: Constancy tests - Film processors IEC 1223-2-2: 19
37、93, Evaluation and routine testing in medical imaging departments - Part 2-2: Constancy tests - Radiographic cassettes and film changers - Film-screen contact and relative sensitivity of the screen-cassette assembly IEC 1223-2-3: 1993, Evaluation and routine testing in medical imaging departments -
38、Part 2-3: Constancy tests - Darkroom safelight conditions IEC 1223-2-4: 1994, Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras IEC 1223-2-1 2: 19XX, Evaluation and routine testing in medical imaging departments - Part 2-12: Constancy fests
39、 - Film illuminators (under consideration) - = 3404589 0083088 bTT Page 8 EN 61223-2-5 : 1994 3 Terminology 3.1 Degree of requirements In this part of IEC 1223 the verbal form: “shall“ “s hou Id“ “may“ The term “specific“ “specified“ implies that compliance with with the standard; requirement is man
40、datory for compliance implies that compliance with a requirement is strongly recommended but is not mandatory for compliance with the standard; implies that compliance with a requirement is permitted to be accomplished in a particular manner, for compliance with the standard. when used with paramete
41、rs or conditions: refers to a particular value or standardized arrangement, usually to those required in an IEC standard or a legal requirement: when used with parameters or conditions: refers to a value or arrangement to be chosen for the purpose under consideration and indicated usually in ACCOMPA
42、NYING DOCUMENTS. 3.2 Use of terms In this part of IEC 1223, terms printed in SMALL CAPITALS are used as defined in IEC 788, 3.3 of this standard or other IEC publications referenced in annex A. Where a defined term is used as a qualifier in another defined or undefined term it is not printed in capi
43、tal letters, unless the concept thus qualified is defined, or recognized as a derived term with- out definition. NOTE - 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
44、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. NOTE - Definition from IEC 1223-2-4: HARD COPY CAMERA: Device producing non-erasable images on a sheet of material from an input
45、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. This holds especially for HARD COPY CAMERAS and IMAGE DISPLAY DEVICES. If the HARD COPY CAMERA and IMAGE DIS
46、PLAY DEVICE are properly adjusted and maintained (see clause 2) both should consistently produce images that appear similar. Page 9 EN 61223-2-5 : 1994 The methods for testing the constancy described in this standard are intended to enable the OPERATOR to detect changes in image quality Of images pr
47、oduced 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 parameters under test. In particular, attention shall be paid to darkroom safelig
48、ht conditions and proper film processing (see IEC 1223-2-3, reference in clause 2). Special attention should also be paid to ambient lighting conditions, when using FILM ILLUMINATORS (see 1223-2-12, reference in clause 2). Careful consideration shall be given to the operating and test conditions, un
49、der 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 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 The CONSTANCY TESTS described in this standard have been designed to be robust, that is, their results should be affected only by changes i
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