EN 60627-2001 en Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (Incorporating Corrigendum August 2002 Remains Current).pdf

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1、BRITISH STANDARD BS EN 60627:2001 IEC 60627:2001 Incorporating Corrigendum No. 1 Diagnostic X-ray imaging equipment Characteristics of general purpose and mammographic anti-scatter grids The European Standard EN 60627:2001 has the status of a British Standard ICS 11.040.50; 11.040.55 BS EN 60627:200

2、1 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 05 December 2001 BSI 23 October 2002 ISBN 0 580 38756 9 National foreword This Bri

3、tish Standard is the official English language version of EN 60627:2001, including Corrigendum August 2002. It is identical with IEC 60627:2001. It supersedes BS 5913:1980 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/73, X-ray equipment componen

4、ts, protection and utilization, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found

5、in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are respons

6、ible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests

7、informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 28, an inside back cover and a back cover. The BSI copyright date displayed in this document i

8、ndicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14056 Corrigendum No. 1 23 October 2002 Addition of supersession details to EN title page and EN forewordEUROPEAN STANDARD EN 60627 NORME EUROPENNE EUROPISCHE NORM November 2001 CENELEC European Co

9、mmittee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENEL

10、EC members. Ref. No. EN 60627:2001 E ICS 11.040.50 Supersedes EN 61953:1998 Incorporating Corrigendum August 2002 English version Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001) Equipements de diagnostic par imagerie rayonn

11、ement X - Caractristiques des grilles antidiffusantes dusage gnral et de mammographie (CEI 60627:2001) Bildgebende Gerte fr die Rntgendiagnostik - Kenngren von Streustrahlenrastern fr die allgemeine Anwendung und fr die Mammographie (IEC 60627:2001) This European Standard was approved by CENELEC on

12、2001-11-01. CENELEC members are bound to comply with the CEN/CENELEC 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

13、be obtained on application 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 t

14、he Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden,

15、Switzerland and United Kingdom.Foreword The text of document 62B/436A/FDIS, future edition 2 of IEC 60627, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60627

16、on 2001-11-01. This European Standard supersedes EN 61953:1998. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2002-08-01 latest date by which the national standards conflict

17、ing with the EN have to be withdrawn (dow) 2004-11-01 Annexes designated “normative“ are part of the body of the standard. In this standard, annexes A, B and ZA are normative. Annex ZA has been added by CENELEC. In this standard, the following print types are used: requirements, compliance with whic

18、h can be tested, and definitions: in roman type; explanations, advice, notes, general statements, exceptions and references: in smaller roman type; test specifications: in italic type; TERMS DEFINED IN EN 60601-1, IN EN 60788, IN CLAUSE 3 OF THIS STANDARD OR IN OTHER IEC PUBLICATIONS REFERENCED IN A

19、NNEX B: IN SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 60627:2001 was approved by CENELEC as a European Standard without any modification. _ Page2 EN60627:200160627 IEC:2001 3 CONTENTS INTRODUCTION 4 1 Scope and object. 5 2 Normative references. 5 3 Terminology. 6

20、 3.1 Degree of requirements . 6 3.2 Use of terms. 6 3.3 Defined terms . 6 4 Structure of ANTI-SCATTER GRIDS. 9 5 Measurement and determination of physical characteristics10 5.1 Method and arrangement for measurement10 5.2 Physical characteristics .13 6 Requirements for ANTI-SCATTER GRIDS .15 6.1 Man

21、ufacturing tolerances.15 6.2 Determination of the APPLICATION LIMITS for PARALLEL GRIDS and FOCUSED GRIDS 15 6.3 Accuracy of characteristics 15 6.4 Marking and ACCOMPANYING DOCUMENTS 16 6.5 Statement of compliance .17 Annex A (normative) Calculation of the APPLICATION LIMITS .24 Annex B (normative)

22、Terminology Index of defined terms25 Annex ZA (normative) Normative references to international publications with their corresponding European publications28 Bibliography27 Figure 1 Structure of ANTI-SCATTER GRIDS .18 Figure 2 RADIATION DETECTOR.19 Figure 3a Measurement arrangement for general purpo

23、se ANTI-SCATTER GRIDS with NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION)20 Figure 3b Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with NARROW-BEAM CONDITION (determination of the TRANSMISSION OF PRIMARY RADIATION).21 Figure 4a Measurement arrangement f

24、or general purpose ANTI-SCATTER GRIDS with BROAD-BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) 22 Figure 4b Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with BROAD-BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) 23 Page3 EN60627:20

25、01 1002:rebmeceD50ISB60627 IEC:2001 4 INTRODUCTION The first edition of IEC 60627 was intended for ANTI-SCATTER GRIDS used in general radio- graphy and is not appropriate for ANTI-SCATTER GRIDS used in mammography. As a consequence, a complementary standard IEC 61953 was published. During the prepar

26、ation of this latter standard, it became clear that a revision of IEC 60627 itself was necessary, and it was decided to merge together the two standards covering ANTI-SCATTER GRIDS. Wherever possible, a harmonized approach has been used. Where there are differences in this standard between general p

27、urpose ANTI-SCATTER GRIDS and MAMMOGRAPHIC ANTI-SCATTER GRIDS, these are listed as items a) and b) respectively. Some of the differences for general purpose ANTI-SCATTER GRIDS between this second edition and the first edition of IEC 60627 are outlined below: some definitions have been modified and o

28、thers added to improve clarity, harmonization or generality; the concept of a reference ANTI-SCATTER GRID is now omitted. It was found that such ANTI- SCATTER GRIDS were little used. It should be sufficient to define unambiguously the RADIATION DETECTOR and the measuring procedure; t h e s a m e PHA

29、NTOM is used for measurements of TRANSMISSION OF PRIMARY RADIATION and TRANSMISSION OF SCATTERED RADIATION; t h e RADIATION QUALITIES used for the measurement have been changed and are now qualities specified in IEC 61267; a lower energy X-RAY SPECTRUM than before is used to measure the performance

30、of general purpose ANTI-SCATTER GRIDS. This was considered to be more appropriate than the spectrum previously used; where a general purpose ANTI-SCATTER GRID is specified for low-energy use, additional measurements have now to be made with appropriate, specified RADIATION QUALITIES; the diameter of

31、 the measuring field is reduced; t h e TRANSMISSION OF PRIMARY RADIATION is now given on the ANTI-SCATTER GRID or in the ACCOMPANYING DOCUMENTS; information on the nature of the material used for the grid interspace and on the nature of the grid covers is now given in the ACCOMPANYING DOCUMENTS; app

32、lication limits are now given for PARALLEL GRIDS; the position of the grid centre is now indicated. Special laboratory provisions and carefully controlled test conditions are needed for the measurements described here. Page4 EN60627:2001 1002:rebmeceD50ISB60627 IEC:2001 5 DIAGNOSTIC X-RAY IMAGING EQ

33、UIPMENT Characteristics of general purpose and mammographic anti-scatter grids 1 Scope and object This International Standard deals with the definitions, determination and indication of characteristics of ANTI-SCATTER GRIDS used in diagnostic X-ray imaging equipment, in order to reduce the incidence

34、 of SCATTERED RADIATION, produced particularly in the body of the PATIENT, upon the IMAGE RECEPTION AREA and thus to improve the contrast of the X-RAY PATTERN. In this standard only LINEAR GRIDS are considered. Since at present only FOCUSED GRIDS are used in mammography, this standard is restricted

35、to FOCUSED GRIDS for MAMMOGRAPHIC ANTI-SCATTER GRIDS. This standard is not intended to be applied for ACCEPTANCE TESTS. This standard does not cover the homogeneity of performance over the area of a grid. This standard is intended to be applied for the demonstration of the characteristics of ANTI- S

36、CATTER GRIDS under test conditions. These conditions are not usually available at the USERs site. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest

37、 edition of the referenced document (including any amendments) applies. IEC 60417 (all parts), Graphical symbols for use on equipment IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety IEC 60788, Medical radiology Terminology IEC 61223-1, Evaluation and routine testing

38、 in medical imaging departments Part 1: General aspects IEC 61267, Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristics Page5 EN60627:2001 1002:rebmeceD50ISB60627 IEC:2001 6 3 Terminology 3.1 Degree of requirements In this standard, certain terms wh

39、ich are not printed in SMALL CAPITALS have particular meanings: “shall“ indicates a requirement that is mandatory for compliance; “should“ indicates a strong recommendation that is not mandatory for compliance; “may“ indicates a permitted manner of complying with a requirement or of avoiding the nee

40、d to comply; “specific“ is used to indicate definitive information stated in this standard or referenced in other standards, usually concerning particular operating conditions, test arrangements or values connected with compliance; “specified“ is used to indicate definitive information stated by the

41、 MANUFACTURER in ACCOMPANYING DOCUMENTS or in other documentation relating to the EQUIPMENT under consideration, usually concerning its intended purpose, or the parameters or conditions associated with its use or with testing to determine compliance. 3.2 Use of terms In this standard, terms printed

42、in SMALL CAPITALS are used as defined in IEC 60601-1, in IEC 60788, in 3.3 of this standard or in other IEC publications referenced in annex B. 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 l

43、isted above a corresponding term is printed in lower-case letters. An index of defined terms used in this standard is given in annex B. 3.3 Defined terms For the purpose of this International Standard, the following definitions apply. NOTE Some of the defined terms given in this standard deviate fro

44、m those given in the current edition of IEC 60788. 3.3.1 ANTI-SCATTER GRID device with a fixed periodic arrangement of materials with different X-ray ATTENUATION properties to be placed in front of the IMAGE RECEPTION AREA in order to reduce the incidence of SCATTERED RADIATION upon that area and th

45、us increase the contrast in the X-RAY PATTERN 3.3.2 LINEAR GRID ANTI-SCATTER GRID composed of highly absorbing strips and highly transmitting interspaces which are parallel in their longitudinal direction 3.3.3 PARALLEL GRID LINEAR GRID in which the planes of the absorbing strips are parallel to eac

46、h other and perpendicular to the incident face Page6 EN60627:2001 1002:rebmeceD50ISB60627 IEC:2001 7 3.3.4 FOCUSED GRID LINEAR GRID in which the planes of the absorbing strips converge to a straight line at the FOCUSING DISTANCE 3.3.5 TAPERED GRID LINEAR GRID in which the height of the absorbing str

47、ips decreases as the distance between the absorbing strips and the TRUE CENTRAL LINE increases. This decrease is symmetrical about the TRUE CENTRAL LINE 3.3.6 CROSS-GRID ANTI-SCATTER GRID composed of two LINEAR GRIDS built together in such a way that the directions of their absorbing strips form an

48、angle 3.3.6.1 ORTHOGONAL CROSS-GRID CROSS-GRID in which the directions of the absorbing strips form an angle of 90 3.3.6.2 OBLIQUE CROSS-GRID CROSS-GRID in which the directions of the absorbing strips form an angle other than 90 3.3.7 STATIONARY GRID ANTI-SCATTER GRID used in such a way that it does

49、 not move in relation to the RADIATION BEAM 3.3.8 MOVING GRID ANTI-SCATTER GRID used in an ACCESSORY that enables the ANTI-SCATTER GRID to be moved, when irradiated by a RADIATION BEAM, in order to avoid the imaging of the absorbing strips and the consequent loss of information 3.3.9 MAMMOGRAPHIC ANTI-SCATTER GRID FOCUSED GRID specially designed for mammo