BS EN 61223-2-4-1995 Evaluation and routine testing in medical imaging departments - Constancy tests - Method for hard copy cameras《医用成像部门常规试验评定 稳定性试验 硬拷贝摄影机试验法》.pdf

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1、BRITISH STANDARD BS EN 61223-2-4:1995 BS 7725-2.4: 1995 IEC 1223-2-4: 1994 Evaluation and routine testing in medical imaging departments Part 2: Constancy tests Section 2.4 Method for hard copy cameras The European Standard EN61223-2-4:1994 has the status of a British Standard UDC 615.84:771.31:620.

2、1BSEN61223-2-4:1995 This British Standard, having been prepared under the directionof the Sector Board forHealth and Environment, waspublished under the authorityof the Standards Boardand comes intoeffecton 15February1995 BSI 01-2000 The following BSI references relate to the work on this standard:

3、Committee reference HCC/73 Draft for comment 91/51028 DC ISBN 0 580 23751 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/73, Interchangeable X-ray components, upon which the following bodies were represented: Briti

4、sh 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 CommentsBSEN61223-2-4:1995 BSI 01-2000 i Contents Page Committees resp

5、onsible Inside front cover National foreword ii Foreword 2 Text of EN 61223-2-4 3 List of references Inside back coverBSEN61223-2-4:1995 ii BSI 01-2000 National foreword This British Standard has been prepared by Technical Committee HCC/73, Interchangeable X-ray components, and is the English langua

6、ge version of EN61223-2-4:1994 Evaluation and routine testing in medical imaging departments Part 2-4:1994 Constancy tests Hard copy cameras, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC1223-2-4:1994 published by the International Elect

7、rotechnical 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-refer

8、ences International Standard Corresponding British Standard IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms BS 7725 Evaluation and routine testing in medical imaging departments IEC 1223-1:1993 Part 1:1994 General Part 2 Constancy tests IEC 1223-2-1:1993 Section 2.1:1994 Method for fil

9、m processors IEC 1223-2-2:1993 Section 2.2:1994 Method for radiographic cassettes and film changers and film-screen contact and relative sensitivity of the screen-cassette assembly IEC 1223-2-3:1993 Section 2.3:1994 Method for darkroom safelight conditions IEC 1223-2-5:1994 Section 2.5:1994 Method f

10、or image display devices Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages 2 to 18, 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 i

11、ndicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61223-2-4 June 1994 UDC 615.84:771.31:620.1 Descriptors: Electromedical equipment, hard copy camera, medical imaging, constancy test, evaluation testing, routine testing English version Eva

12、luation and routine testing in medical imaging departments Part 2-4: Constancy tests Hard copy cameras (IEC 1223-2-4:1994) Essais dvaluation et de routine dans les services dimagerie mdicale Partie 2-4: Essais de constance Reprographes (CEI 1223-2-4:1994) Bewertung und routinemige Prfung in Abteilun

13、gen fr medizinische Bildgebung Teil 2-4: Konstanzprfungen Bilddokumentationssysteme (IEC 1223-2-4:1994) 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 European S

14、tandard 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 (English,

15、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, Belgi

16、um, 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 Elek

17、trotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1994 Copyright reserved to CENELEC members Ref. No. EN 61223-2-4:1994 EEN61223-2-4:1994 BSI 01-2000 2 Foreword The text of document 62B(CO)105, as prepared by Sub-Committee62B, Diagnostic imaging equipment, of IEC Technic

18、al Committee62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote in May1993. The reference document was approved by CENELEC as EN61223-2-4 on8March1994. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexe

19、s designated “informative” are given only for information. In this standard, Annex A andAnnex ZA are normative andAnnex B, Annex C, Annex D andAnnex E are informative. Contents Page Introduction 3 1 Scope and object 3 1.1 Scope 3 1.2 Object 3 2 Normative references 3 3 Terminology 3 3.1 Degree of re

20、quirements 3 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 4 4.3 Frequency of CONSTANCY TESTS 4 4.4 Identification of equipment, instrumentation and test conditions 5 4.5 Measured fu

21、nctional parameters 5 5 Test methods 5 5.1 Summary 5 5.2 Test equipment 5 5.3 Test procedure 6 5.4 Data evaluation 7 Page 5.5 Criteria to be applied 7 5.6 Test report 8 5.7 Action to be taken 8 5.8 Frequency of testing 8 6 Statement of compliance 8 Annex A (normative) Terminology Index of terms 13 A

22、nnex B (informative) Example of a form for the standardized test report 14 Annex C (informative) Guidance on action to be taken 15 Annex D (informative) Rationale 15 Annex E (informative) Bibliography Reference test pattern 16 Annex ZA (normative) Other international publications quoted in this stan

23、dard with the references of the relevant European publications 17 Figure 1 Schematic representation of a test pattern used to check the constancy with respect to grey-scale reproduction 9 Figure 2 Schematic representation of a test pattern used to check the constancy with respect to geometry and lin

24、e structure 10 Figure 3 Schematic representation of a crosshatched pattern used to carry out measurements with respect to geometry 11 Figure 4 Schematic representation of a test pattern used to check the constancy with respect to resolution 12 latest date of publication of an identical national stan

25、dard (dop) 1995-03-01 latest date of withdrawal of conflicting national standards (dow) 2000-03-01EN61223-2-4:1994 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, Rationale. An aster

26、isk 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 HARD COPY CAMERAS producing images on monochrome continuous tone material (such as photographic films and materials sensitive to infrare

27、d radiation), and comprising types of cameras using a cathode ray tube, laser beam, or a thermoprinting system, as used in diagnostic imaging systems such as: digital radiography; digital subtraction angiography; imaging in COMPUTED TOMOGRAPHY; magnetic resonance imaging; ultrasound imaging; imaging

28、 in NUCLEAR MEDICINE. *The test methods are based on the use of test patterns. This standard does not apply to x-y (analogue) recording systems used in NUCLEAR MEDICINE. This standard is a part of a series of Particular Publications (standards and technical reports) which give methods of tests for t

29、he constancy of properties of diagnostic imaging systems as described in IEC1223-1 (see clause2). 1.2 Object* This part of IEC1223 describes a method to check, in terms of functional parameters, the constancy of the quality of images produced by HARD COPY CAMERAS in order to ensure that the required

30、 conditions for producing consistent hard copies are maintained after the calibration and adjustment have been carried out. The aims of the method are: to establish a reference level of performance for the HARD COPY CAMERA when such equipment has been accepted; to detect and verify any significant v

31、ariation in functional parameters which may then require corrective actions. With regard to the measurements, reference is made to methods described in related publications, which for practical reasons should be carried out prior to the application of the method described in this standard (see claus

32、e2). 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 valid. All normative documents are subject to revision, and parties to agreem

33、ents based on this part of IEC1223 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC 788:1984, Medical radiology Terminology. IEC 122

34、3-1:1993, Evaluation and routine testing in medical imaging departments Part 1: General aspects. IEC 1223-2-1:1993, Evaluation and routine testing in medical imaging departments Part 2-1: Constancy tests Film processors. IEC 1223-2-2:1993, Evaluation and routine testing in medical imaging department

35、s 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 Part 2-3: Constancy tests Darkroom safelight conditions. IEC 1223-2-5:19

36、94, Evaluation and routine testing in medical imaging departments Part 2-5: Constancy tests Image display devices. IEC 1223-2-12:19XX, Evaluation and routine testing in medical imaging departments Part 2-12: Constancy tests Film illuminators (under consideration). 3 Terminology 3.1 Degree of require

37、ments In this part of IEC1223 the verbal form: “shall” implies that compliance with a requirement is mandatory for compliance with the standard; “should” implies that compliance with a requirement is strongly recommended but is not mandatory for compliance with the standard; “may” implies that compl

38、iance with a requirement is permitted to be accomplished in a particular manner, for compliance with the standard.EN61223-2-4:1994 4 BSI 01-2000 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 Public

39、ations referenced 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 wher

40、e 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. 3.3 Definitions 3.3.1 HARD COPY CAMERA device producing non-erasable images on a sheet of material from an input signal provided by

41、 an imaging system NOTEDefinition from IEC1223-2-5: IMAGE DISPLAY DEVICE:Device capable of displaying images from an input signalprovided 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 o

42、f the system. This holds especially for HARD COPY CAMERAS and IMAGE DISPLAY DEVICES. *If HARD COPY CAMERAS and IMAGE DISPLAY DEVICE are properly adjusted and maintained (see clause2) both equipment should consistently produce images that appear similar. The methods for testing the constancy describe

43、d in this standard are intended to enable the OPERATOR to detect changes in image quality of images produced by HARD COPY CAMERAS. 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 tha

44、n changes in the parameters under test. 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 lighting conditions, when using FILM ILLUMINATORS (see IEC1223-2-12, reference in clause2). Car

45、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 a

46、nd 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 been

47、 designed to be robust, that is, their results should be affected only by changes in the parameters under investigation. The range of test pattern and test equipment has been kept to a minimum and restricted where possible to devices that are passive, inherently simple or reasonably stable. However,

48、 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 the standards or technical reports referenced in clause2. 4.2 Establishment of BASELINE

49、VALUES When new diagnostic imaging equipment is brought into use, or any component of the diagnostic imaging equipment, ACCESSORIES or test equipment is changed which may cause a variation in the test result, an initial CONSTANCY TEST shall be carried out immediately after an ACCEPTANCE TEST or STATUS TEST has indicated that the standard of performance is satisfactory. The purpose of the initial CONSTANCY TEST is to establish new BASELINE VALUE(S) for the parameter(s) tested. 4.3 Frequency of CON