BS EN 61223-3-3-1997 Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiograp hy《.pdf

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1、BRITISH STANDARD BS EN 61223-3-3: 1997 BS 7725-3.3: 1997 IEC1223-3-3: 1996 Evaluation and routine testing in medical imaging departments Part 3: Acceptance tests Section 3.3 Imaging performance of X-ray equipment for digital subtraction angiography (DSA) The European Standard EN 61223-3-3:1996 has t

2、he status of a British Standard ICS 11.040.50BSEN61223-3-3:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof the Standards Boardand comes into effect on 15June1997 BSI 10-1999 The following BSI reference

3、s relate to the work on this standard: Committee reference CH/73 Draft for comment 94/508379 DC ISBN 0 580 27605 8 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/73, Radiation protection dose control and utilization,

4、upon which the following bodies were represented: Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Dental Association British Insitute of Radiology British Medical Association College of Radiographers Confederation of British Forgers Department of Health Flat Glass Manufacturers Ass

5、ociation Health and Safety Executive Institute of Physics and Engineering in Medicine and Biology National Radiological Protection Board Royal College of Radiologists Society of X-ray Technology Amendments issued since publication Amd. No. Date CommentsBSEN61223-3-3:1997 BSI 10-1999 i Contents Page

6、Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN61223-3-3 3 List of references Inside back coverBSEN61223-3-3:1997 ii BSI 10-1999 National foreword This British Standard has been prepared by Technical Committee CH/73. It is the English language version of EN61223-

7、3-3:1996 Evaluation and routine testing in medical imaging departments Part 3-3:Acceptance tests Imaging performance of X-ray equipment for digital subtraction angiography (DSA), published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC1223-3-3:1996

8、 published by the International Electrotechnical Commission (IEC). Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in s

9、mall roman type. Test procedures: in italic type. Terms defined in BS7725or in BS6641: SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. Cross-references Publication referred to Corresponding British Standard IEC 417N:1995 BS

10、 6217:1981 Guide to graphical symbols for use on electrical equipment BS 5724 Medical electrical equipment IEC 601-1:1988 Part 1:1989 General requirements for safety IEC 601-1:1988 Amendment 1:1991 Amendment 2 to BS5724-1:1989 General requirementsfor safety IEC 601-1:1988 Amendment 2:1995 Amendment

11、3 to BS 5724-1:1989 General requirements for safety. (To be published) BS EN 60601-1-3:1995 Medical electrical equipment Part1 Generalrequirements for safety. IEC 601-1-3:1994 Section 1.3:1995 Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment BS 5724 Me

12、dical electrical equipment Part 2: Particular requirements for safety IEC 601-2-7:1987 Section 2.7:1987 Specification for high-voltage generators of diagnostic X-ray generators IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms IEC 878:1988 BS 7139:1989 Guide to graphical symbols for use

13、on medical electrical equipment BS 7725 Evaluation and routine testing in medical imaging departments IEC 1223-1:1993 Part 1:1994 General Part 2 Constancy tests IEC 1223-2-4:1994 BS EN 61223-2-4:1995 Method for hard copy cameras IEC 1223-2-5:1994 BS EN 61223-2-5:1995 Method for image display service

14、sBSEN61223-3-3:1997 BSI 10-1999 iii 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. Summa

15、ry of pages This document comprises a front cover, an inside front cover, pages i to iv, pages1to 14, 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 table on the inside front

16、 cover.iv blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61223-3-3 December 1996 ICS 11.040.50 Descriptors: Medical electrical equipment, medical imaging, angiography, acceptance tests, performance English version Evaluation and routine testing in medical imaging departments Part 3-3: Acc

17、eptance tests Imaging performance of X-ray equipment for digital subtraction angiography (DSA) (IEC1223-3-3:1996) Essais dvaluation et de routine danslesservices dimagerie mdicale Partie3-3: Essais dacceptation Performancedimagerie des quipementsrayonnement X dangiographienumrique soustractive (ANS)

18、 (CEI1223-3-3:1996) Bewertung und routinemige Prfung inAbteilungen fr medizinische Bildgebung Teil 3-3: Abnahmeprfungen Abbildungsleistung von Rntgen-Einrichtungen fr Digitale Subtraktionsangiographie (IEC1223-3-3:1996) This European Standard was approved by CENELEC on1996-10-01. CENELEC members are

19、 bound to comply with the 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 application to the Central S

20、ecretariat 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 has the same status a

21、s 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 Committee for Elec

22、trotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1996 Copyright reserved to CENELEC members Ref. No.EN 61223-3-3:1996 EEN61223-3-3:1996 2 BSI 10-1999 Foreword The tex

23、t of document62B/288/FDIS, future edition1 of IEC1223-3-3, prepared by SC62B, Diagnostic imaging equipment, of IECTC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN61223-3-3 on1996-10-01. The following dates were fixed: An

24、nexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex A and Annex ZA are normative and Annex B and Annex C are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the Int

25、ernational Standard IEC1223-3-3:1996 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 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 requirements 3 3.2 Use of terms 4 3.3 Defined ter

26、ms 4 4 General aspects of ACCEPTANCE TESTS 4 Page 4.1 General conditions to be considered in test procedures 4 4.2 Documents and data for the tests 4 4.3 Test conditions 5 4.4 Test parameters 5 4.5 Test equipment including PHANTOMS and TEST DEVICES 5 4.6 Evaluating the test results 6 5 Test methods

27、for X-RAY EQUIPMENT forDSA 6 5.1 Identification 6 5.2 Check of documents 6 5.3 Decision on representative DSA operationmodes 6 5.4 Visual and functional tests 6 5.5 AIR KERMA measurements 7 5.6 DYNAMIC RANGE 7 5.7 DSA CONTRAST SENSITIVITY 7 5.8 DSA VISUAL SPATIAL RESOLUTION 7 5.9 ARTIFACTS 7 5.10 Co

28、mpensation for ATTENUATION non-linearity (optional) 7 6 Test report and statement of compliance 8 Annex A (normative) Terminology Index ofdefined terms 9 Annex B (informative) Example of a DSA PHANTOM withoutteststep for compensation 10 Annex C (informative) Example of a DSA PHANTOM with teststepfor

29、 compensation 12 Annex ZA (normative) Normative references tointernational publications with their corresponding European publications 14 Figure B.1 DSA PHANTOM without test stepforcompensation 11 Figure C.1 DSA PHANTOM with test stepforcompensation 13 latest date by which the EN has to be implement

30、edat national level by publication of an identical national standard or by endorsement (dop) 1997-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 1997-08-01EN61223-3-3:1996 BSI 10-1999 3 Introduction This standard is part of a series of Internatio

31、nal Standards which give methods of acceptance testing and constancy testing for subsystems and systems (e.g. diagnostic X-RAY EQUIPMENT), including film processing, used in medical imaging departments. 1 Scope and object 1.1 Scope This part of IEC1223applies to those components of X-RAY EQUIPMENT w

32、hich influence the image quality of EQUIPMENT for digital subtraction angiography (DSA) with an imaging system consisting of an X-RAY generation subsystem, a detection device comprising an X-RAY IMAGE INTENSIFIER television chain, means of digitization and digital image processing, image storage and

33、 image manipulation including subtraction, and facilities for image display. This standard does not apply to general equipment of digital imaging. If such an equipment includes a DSA function, it is restricted to the DSA function. 1.2 Object This part of IEC1223defines: a) the essential parameters w

34、hich describe the performance of the above-mentioned components of X-RAY EQUIPMENT with regard to imaging properties; b) methods of testing whether measured quantities related to those parameters comply with specified tolerances. These methods mainly rely on non-invasive measurements using appropria

35、te test equipment performed during the installation or after the installation is completed. Signed statements covering steps in the installation procedure can be used as part of acceptance testing. The aim is to verify compliance of the installation with specifications affecting the image quality, a

36、nd to detect malfunctions affecting the image quality that are not in agreement with those specifications. This standard does not in itself specify tolerances for the parameters under investigation. Neither is it intended to consider: c) aspects of mechanical and electrical safety; d) aspects of mec

37、hanical, electrical and software performance unless they are essential to the performance of the tests directly affecting the image quality. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IEC122

38、3. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this part of IEC1223are encouraged to investigate the possibility of applying the most recent editions of the normative documents listed below. Member

39、s of IEC and ISO maintain registers of currently valid International Standards. IEC 417N:1995, Graphical symbols for use on equipment Index, survey and compilation of the single sheets Thirteenth supplement. IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. Amendm

40、ent1(1991) Amendment2(1995) IEC 601-1-3:1994, Medical electrical equipment Part 1: General requirements for safety 3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment. IEC 601-2-7:1987, Medical electrical equipment Part 2: Particular requirements for t

41、he safety of high-voltage generators of diagnostic X-ray generators. IEC 788:1984, Medical radiology Terminology. IEC 878:1988, Graphical symbols for electrical equipment in medical practice. IEC 1223-1:1993, Evaluation and routine testing in medical imaging departments Part 1: General aspects. IEC

42、1223-2-4:1994, Evaluation and routine testing in medical imaging departments Part 2-4: Constancy tests Hard copy cameras. IEC 1223-2-5:1994, Evaluation and routine testing in medical imaging departments Part 2-5: Constancy tests Image display devices. ISO 2092:1981, Light metals and their alloys Cod

43、e of designation based on chemical symbols. 3 Terminology 3.1 Degree of requirements In this part of IEC1223, certain terms (which are not printed in SMALL CAPITALS) have particular meanings, as follows: “shall” indicates a requirement that is mandatory for compliance;EN61223-3-3:1996 4 BSI 10-1999

44、3.2 Use of terms In this part of IEC1223, terms printed in SMALL CAPITALS are used as defined in IEC788or other IEC publications or in3.3 of this standard; seeAnnex A. Where a defined term is used as a qualifier with another defined or undefined term it is not printed in SMALL CAPITALS, unless the c

45、oncept thus qualified is defined, or recognized as a derived term without a definition. NOTEAttention 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-cas

46、e letters. 3.3 Defined terms 3.3.1 ARTIFACT apparent structure visible in the image which does not represent a structure within the object and which cannot be explained by noise or the MODULATION TRANSFER FUNCTION of the system 3.3.2 DSA CONTRAST SENSITIVITY ability of the DSA system to display low

47、contrast vessels against background 3.3.3 DSA VISUAL SPATIAL RESOLUTION ability of the DSA system to display small structures of high contrast NOTEDSA VISUAL SPATIAL RESOLUTION depends both on technical and observer performance. 3.3.4 DYNAMIC RANGE range of ATTENUATION that can be used for subtracti

48、on 4 General aspects of ACCEPTANCE TESTS 4.1 General conditions to be considered in test procedures The aim of an ACCEPTANCE TEST is to demonstrate that the specified characteristics of the EQUIPMENT lie within the specified tolerances. Some requirements are enforced by legislation. Other requiremen

49、ts and specifications may be in the order contract, in the suppliers brochure or in other standards, e.g. IEC601series. Prior to the performance test procedures an inventory of the EQUIPMENT under test shall be established. The X-RAY EQUIPMENT and its components shall be unambiguously identified, e.g.with respect to type and SERIAL NUMBER, and checked against the order contract. The check shall also encompass ascertaining that the ACCOMPANYING DOCUMENTS, including test protocols, are complete, that delivery