BS EN 60406-1997 Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis《X射线医疗诊断用X射线胶片暗盒和乳腺X射线胶片暗盒》.pdf

1、BRITISH STANDARD BS EN 60406:1997 IEC 60406: 1997 Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis The European Standard EN 60406:1997 has the status of a British Standard ICS 11.040.50BSEN60406:1997 This British Standard, having been prepared unde

2、r the directionof the Health and Environment Sector Board, waspublished under the authority of the Standards Board and comes into effect on 15August1997 BSI 09-1999 ISBN 0 580 27717 8 Amendments issued since publication Amd. No. Date CommentsBSEN60406:1997 BSI 09-1999 i Contents Page National forewo

3、rd ii Foreword 2 Text of EN 60406 3BSEN60406:1997 ii BSI 09-1999 National foreword This British Standard is the English language version of EN60406:1997. It is identical with IEC60406:1997. It supersedes BS7534:1991 which is withdrawn. The UK participation in its preparation was entrusted to Technic

4、al Committee CH/73, Radiation protection dose control and utilization, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;

5、monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. From1January1997, all IEC publications have the number60000 added to the old number. For instance, IEC27-1 has bee

6、n renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact thatAnnex ZA lists normative references to international publications with their cor

7、responding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or using the “Find” facility of the BSI Standards Electronic Cat

8、alogue. Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and defintions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defi

9、ned in clause3 of this standard or in BS6641: SMALL CAPITALS. 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 fro

10、m legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages2 to 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 indica

11、ted in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60406 May 1997 ICS 37.040.99 Supersedes HD 356 S1:1977 English version Cassettes for medical X-ray diagnosis Radiographic cassettes and mammographic cassettes (IEC 60406:1997) Cassettes pour la

12、radiographie mdicale Cassettes radiographiques et cassettes mammographiques (CEI 60406:1997) Kassetten fr medizinische Rntgenaufnahmen Rntgenkassetten und Mammographie-Kassetten (IEC 60406:1997) This European Standard was approved by CENELEC on1997-03-11. CENELEC members are bound to comply with the

13、 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 be obtained on application to the Central Secretariat or

14、 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 as the offici

15、al 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 UnitedKingdom. CENELEC European Committee for Electrotechnical

16、Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1997 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60406:199

17、7 EEN60406:1997 2 BSI 09-1999 Foreword The text of document62B/292/FDIS, future edition3 of IEC60406, prepared by SC62B, Diagnostic imaging equipment, of IEC TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN60406 on1997-0

18、3-11. This European Standard supersedes HD356 S1:1977. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard,Annex A,Annex B, Annex C,Annex D andAnnex ZA are normative and

19、Annex E is informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC60406:1997 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 1 Scope 3 2 Normative references 3 3 Terminology 3 3.1 Degree of requi

20、rements 3 3.2 Use of terms 3 3.3 Defined term 3 4 RADIOGRAPHIC CASSETTES (except mammographic cassettes) 3 4.1 Dimensions 3 4.2 Denomination 4 Page 4.3 Preferred nominal sizes 4 4.4 Outer dimensions 4 4.5 Outer geometrical accuracy 5 4.6 Inner geometrical accuracy 5 4.7 Quality of materials 5 4.8 De

21、sign 6 5 Mammographic cassettes 6 5.1 Dimensions 6 5.2 Denomination 7 5.3 Preferred nominal sizes 7 5.4 Outer dimensions 7 5.5 Outer geometrical accuracy 7 5.6 Inner geometrical accuracy 7 5.7 Quality of materials 7 5.8 Design 7 5.9 Compression 8 5.10 Film-thorax distance 8 5.11 Free field for the R

22、ADIATION DETECTOR 8 Annex A (normative) Test for light-proofness 10 Annex B (normative) Test for film-screen contact 10 Annex C (normative) Test for film-screen contact for mammography 11 Annex D (normative) Terminology Index ofdefinedterms 12 Annex E (informative) Metric conversions 13 Annex ZA (no

23、rmative) Normative referencestointernational publications withtheircorresponding European publications Inside back cover Figure 1 Outside dimensions 5 Figure 2 Mammographic cassette with freefieldfor the RADIATION DETECTOR (minimumdimensions) for stereotactic biopsy 9 Table 1 Dimensions of RADIOGRAP

24、HIC CASSETTES 4 Table 2 Dimensions of mammographic cassettes 6 Table E.1 Sizes that have an origin in inchsizes 13 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1997-12-01 latest date by which the national

25、 standards conflicting with the EN have to be withdrawn (dow) 1997-12-01EN60406:1997 BSI 09-1999 3 1 Scope This International Standard deals with the manufacture of RADIOGRAPHIC CASSETTES and mammographic cassettes intended to be used with RADIOGRAPHIC SCREENS in medical practice. This standard does

26、 not apply to special cassettes (such as cassettes with built-in ANTI-SCATTER GRIDS, cassettes for simultaneous TOMOGRAPHY). It is provided to ensure that X-RAY EQUIPMENT can be operated with RADIOGRAPHIC CASSETTES of different MANUFACTURERS. 2 Normative references The following normative documents

27、contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encourage

28、d 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 336:1993, X-ray tube assemblies for medical diagnosis Characteristics of focal spots. IEC 658:19

29、79, Radiographic intensifying screens for medical use Dimensions. IEC 788:1984, Medical radiology Terminology. IEC 1223-2-2:1993, Evaluation and routine testing in medical imaging departments Part2-2:Constancy tests Radiographic cassettes and film changers Film-screen contact and relative sensitivit

30、y of the screen-cassette assembly. IEC 1267:1994, Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristics. ISO 2092:1981, Light metals and their alloys Code of designation based on chemical symbols. 3 Terminology 3.1 Degree of requirements In this stan

31、dard, certain terms (which are not printed in SMALL CAPITALS) have particular meanings, as follows: 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used as defined in IEC788, in3.3 of this standard or other IEC publications referenced inAnnex D. Where a defined term is used as

32、 a qualifier in another defined or undefined term it is not printed in SMALL CAPITALS, 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 addressed is not strongly confined to the def

33、inition given in one of the publications listed above, a corresponding term is printed in lower case letters. 3.3 Defined term 3.3.1 RADIOGRAPHIC SCREEN: INTENSIFYING SCREEN intended to be used with RADIOGRAPHIC FILMS or photostimulable phosphor plates intended to be used for RADIOGRAPHY. 4 RADIOGRA

34、PHIC CASSETTES (except mammographic cassettes) 4.1 Dimensions The individual values and their permitted tolerances for the different nominal sizes of cassettes are given inTable 1. NOTEAn explanation of apparent deviations, together with the nominal sizes of35 and43, is given inAnnex E. “shall” indi

35、cates 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; “specific” is used to indicate definitive information stated in this standard or referenced in ot

36、her standards, usually concerning particular operating conditions, test arrangements or values connected with compliance; “specified” is used to indicate definitive information stated by the MANUFACTURER in ACCOMPANYING DOCUMENTS or in other documentation relating to the equipment under consideratio

37、n, usually concerning its intended purposes, or the parameters or conditions associated with its use, or with testing to determine compliance.EN60406:1997 4 BSI 09-1999 Table 1 Dimensions of RADIOGRAPHIC CASSETTES 4.2 Denomination RADIOGRAPHIC CASSETTES are denoted by the nominal size expressed in n

38、umerical values (in centimetres) without adding the unit “cm”. Example: Cassette18 24 (eighteen by twenty-four) denotes a RADIOGRAPHIC CASSETTE for a film with the nominal size18 24. If compliance of a cassette with this standard is to be stated, it shall be indicated in combination with the name or

39、 trade mark of MANUFACTURER or supplier, as in the following examples: a) for a RADIOGRAPHIC CASSETTE for a film with the nominal size18 24: 18 24 IEC60406 or, as appropriate: b) for the same cassette with absorption back, indicating the absorption back attenuating material by the numerical value of

40、 its equivalent thickness and by its chemical symbol: 18 24 IEC60406 0,13Pb. 4.3 Preferred nominal sizes Preferred nominal sizes for cassettes are marked with asterisks inTable 1. 4.4 Outer dimensions The specified thickness of a cassette is intended to ensure that the cassette can be properly fixed

41、 in a defined position (for example within a holder or rails). It is not essential for this dimension to be maintained over the entire area of the cassette. However, in no case shall the maximum tolerance of the thickness as given inTable 1 be exceeded in any part of the cassette end. The corners an

42、d the edges corresponding to the dimensions15 mm and 16,5 mm shall be smoothed. They should be shaped to a maximum radius of6mm and a minimum radius of3mm over a quarter circle. Outer dimensions mm Inner dimensions mm Mass without absorption back g Nominal sizes Width 1 Length 1 Thickness Width Leng

43、th Max. Limits 13 18 a 157,5 207,5 132 182 500 18 24 a 207,5 267,5 15 182 242 800 18 43 a 207,5 459,5 182 434 1000 20 40 a 227,5 427,5 202 402 1000 24 24 267,5 267,5 15 242 242 1000 24 30 a 267,5 327,5 242 302 1000 30 30 327,5 327,5 302 302 1400 30 35 327,5 383,5 302 358 1900 30 40 a 327,5 427,5 302

44、 402 1900 35 35 a 383,5 383,5 15 358 358 1900 35 43 a 383,5 459,5 358 434 1900 40 40 427,5 427,5 402 402 1900 20 96 227,5 987,5 202 962 30 90 327,5 927,5 16,5 302 902 30 120 327,5 1 227,5 302 1 202 Dental RADIOGRAPHY (extra-oral) 13 30 a 157,5 332,5 15 129 307 800 15 30 177,5 327,5 152 302 800 a The

45、 nominal sizes marked with asterisks are to be preferred. +1 0,5 +1 0,5 0 2 0 2 0 2 0 3,5 0 2 0 2 0 3,5EN60406:1997 BSI 09-1999 5 The other edges should be smoothed, rounded or may be squared. The smoothed and rounded edges shall be shaped to a radius of1,5mm over a quarter circle. The greatest valu

46、e for the radius or chamfer results from the minimum required planes as given by the dimensions11mm inFigure 1. All parts of the cassette such as hinges, locks and marking devices shall be within the tolerances given inTable 1 and shall be within the radii limits for corners and edges. 4.5 Outer geo

47、metrical accuracy 4.5.1 Squareness Neither external diagonal of the cassette in the plane of the film (determined by the projection of the extended sides) shall exceed the diagonal of the true rectangle of the maximum permitted length and width, nor shall it be less than the diagonal of a true recta

48、ngle of the minimum permitted length and width. 4.5.2 Flatness When a closed cassette is laid on a flat surface, no part of the cassette shall depart from that surface by more than16mm. 4.5.3 Parallelism The front and back of the cassette shall be parallel to each other within0,3mm over any length o

49、f100mm. 4.6 Inner geometrical accuracy 4.6.1 Squareness Neither diagonal of the film recess shall exceed the diagonal of a true rectangle of the maximum permitted length and width, nor shall it be less than the diagonal of a true rectangle of the minimum permitted length and width. 4.7 Quality of materials 4.7.1 Environment The materials and design of the cassette shall ensure that the shape and the dimensions will comply with the limits for outer dimensions and inner dimensions