EN 60522-1999 en Determination of the Permanent Filtration of X-Ray Tube Assemblies《X 射线管装置的永久滤波的测定 IEC 60522-1999》.pdf

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1、 STD-BSI BS EN b0522-ENGL 1777 Lb24bb9 0782140 TI1 BS EN 60522:1999 IEC 60522:1999 BRITISH STANDARD I Determination of the permanent filtration of X-ray tube assemblies The European Standard EN 605221999 has the status of a British Standard ICs 11.040.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS P

2、ERMITTED BY COPYRIGHT LAW STD-BSI BS EN bB522-ENGL It999 D lb2Vbb9 0782343 958 D direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 Amd. No. O BSI 06-1999 BS EN 60522:1999 Date Comments National

3、 foreword This British Standard is the English language version of EN 60522: 1999. It is identical with IEC 60522:1999. The UK participation in its preparation was entrusted to Technical Committee CW1, Diagnostic imaging equipment and accessories, which has the responsibility to: - aid enquirers to

4、understand the text; - present to the responsible internationailEuropean committee any enquiries on the interpretation, or proposais for change, and keep the UK interests informed; them in the UK - monitor related international and European developments and promuigate A list of organizations represe

5、nted on this committee can be obtained on request to its secretary. From 1 Januasy 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other,

6、publications may contain identifiers from both systems. Cross-references Attention is dram to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponhg European publications. The British Standards which imp

7、lement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “Intemational Standards Correspondence Index“, or by using the “Find“ facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the

8、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. Summary of pages This document comprises a front cover, an inside front cover, the EN title page

9、, pages 2 to 10, an inside back cover and a back cover. I I ISBN O 580 32601 2 I EUROPEAN STANDARD NORME EUROPEENNE EUROPISCHE NORM EN 60522 April 1999 ICs 1 1.040.60 English version Determination of the permanent filtration of X-ray tube assemblies (IEC 60522: 1 999) Dtermination de la filtration p

10、ermanente des gaines quipes (CE1 60522: 1 999) Ermittlung der Eigenfilterung von Rntgenstrahlern (IEC 60522:1999) This European Standard was approved by CENELEC on 1999-04-01. CENELEC members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this

11、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 to any CENELEC member. This European Standard exists in three official versions

12、(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 official versions. CENELEC members are the national electrotechnical committees of Aust

13、ria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique

14、Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 1999 CENELEC - Ail rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60522:1999 E STD-BSI BS EN b0522-ENGL 1977 E 3b246b9 0782343 720 Page

15、 2 EN 60522:1999 Foreword The text of document 62B/359/FDISI future edition 2 of IEC 60522, prepared by SC 626, 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 60522 on 1999-04-01.

16、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) 2000-0 1 -0 1 - latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2002-04-01 Ann

17、exes designated “normative“ are part of the body of the standard. In this standard, annexes A and ZA are normative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 60522:1999 was approved by CENELEC as a European Standard without any modification. Cl

18、ause STD*BSI BS EN b0522-ENGL 1199 lb24b07 07823ii bb7 Page 3 EN 60622:1999 CONTENTS Page Scope and object . 5 1.1 Scope . 5 1.2 Object . 5 Normative references . 5 Terminology . 6 3.1 Degree of requirements . 6 3.2 U,se of terms . 6 3.3 Defined terms . 6 Measurement Of PERMANENT FILTRATION 6 4.1 Ge

19、neral . 6 4.2 Test sample 7 4.3 Generation of the X-RAY BEAM for measurement 7 4.4 RADIATION DETECTOR . 7 4.5 Composition of reference materials . 7 4.6 Method of measurement 7 Indications and statements Of PERMANENT FILTRATION i . 8 Annex A (normative) Terminology - Index of defined terms . 9 Annex

20、 ZA (normative) Normative references to international publications with their corresponding European publications . IO O BSI 06-1999 Page 4 EN 60622:1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES 1 Scope and object 1.1 Scope This International Standard applies to X-RAY TUBE

21、ASSEMBLIES for medical diagnosis and RADIOTHERAPY. 1.2 Object medical diagnosis and RADIOTHERAPY and describes a method for its determination. it contains requirements for statements of compliance for ACCOMPANYING DOCUMENTS and for markings on This standard defines the concept of PERMANENT FILTRATIO

22、N in X-RAY TUBE ASSEMBLIES for X-RAY TUBE ASSEMBLIES. Methods are given to determine tile PERMANENT FILTRATION in an X-RAY TUBE ASSEMBLY With an accuracy that is sufficient to enable the appropriate ADDITIONAL FILTRATION to be provided in order to attain the desired TOTAL FILTRATION. NOTE 1 - This s

23、tandard does not contain requirements for any specific values of PERMANENT FILTRATION or TOTAL FILTRATION to be provided. For X-RAY TUBE ASSEMBLIES and X-RAY EOUIPMENT used for diagnostic purposes, appropriate requirements are given in IEC 60601-1-3. NOTE 2 - The method of determination described in

24、 this standard is suitable as a type test. It is not intended as a test to be applied by the USER. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the

25、editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and IS0 maintai

26、n registers of currently valid International Standards. IEC 60601 -1 : 1988, Medical electrical equipment - Part I: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1 995) a IEC 60601 -1 -3:1994, Medical electrical equipment - Part 7: General requirements for safety - 3. Colla

27、teral Standard: General requirements for radiation protection in diagnostic X-ray equipment IEC 60788: 1 984, Medical radiology - Terminology IS0 20921 981, Light metals and their alloys - Code of designation based on chemical symbols STD-BSI BS EN b0522-ENGL 1977 = Lb24bb9 07821qb Li3T Page 5 EN 60

28、522:1999 3 Terminology 3.1 Degree of requirements In this standard, certain terms which are not printed in SMALL CAPITALS have particular meanings, as follows: - “shall“ - “may“ - “should“ - “specific“ - “specified“ indicates a requirement that is mandatory for compliance; indicates a strong recomme

29、ndation that is not mandatory for compliance; indicates a permitted manner of complying with a requirement or of avoiding the need to comply; is used to indicate definitive information stated in this standard or referenced in other standards, usually concerning particular operating conditions, test

30、arrangements or values connected with compliance; is used to indicate definitive information stated by the MANUFACTURER in ACCOMPANYING DOCUMENTS or in other documentation relating to the equipment under consideration, usually concerning its intended purposes, or the parameters or conditions associa

31、ted with its use or with testing to determine compliance. 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions in this standard, in IEC 60601-1, or in IEC 60788. NOTE - Where terms having definitions in the publication listed above are not

32、printed in small capitals, the definitions do not apply and the meaning is determined by the context. An index of defined terms used in this standard is given in annex A. 3.3 Defined terms For the purpose of this standard, the following additional definition applies. 3.3.1 PERMANENT FILTRATION. The

33、QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed materials intercepting the X-RAY BEAM, that are not intended to be removed for any application and are not provided with means for removal in NORMAL USE. 4 Measurement Of PERMANENT FILTRATION When, in accordance wi

34、th the requirements in clause 5, the PERMANENT FILTRATION is to be expressed in terms of the actual filtering material (e.g. beryllium), the nature and thickness of the material present shall be determined or verified by inspection. In other cases, the following indicated or stated in accordance wit

35、h this standard. test shall be used to determine the PERMANENT FILTRATION Of gn X-RAY TUBE ASSEMBLY to be 4.1 General The PERMANENT FILTRATION is determined by measuring the QUALITY EQUIVALENT FILTRATION of samples of the permanently fixed materials, used in the construction of the X-RAY TUBE ASSEMB

36、LY, that intercept the X-RAY BEAM. Where appropriate, a composite sample replicating the combination of the various materials and their thicknesses, as actually used in the construction, can be tested. Alternatively, the PERMANENT FILTRATION can be computed from measurements on samples of the indivi

37、dual materials concerned, provided that: STD.BSI BS EN b0522-ENGL 1779 m Lb24bb7 0782197 37b Page 6 EN 60522:1999 - the reference material is the same for each sample and, - the RADIATION QUALITY of the X-RAY BEAM used for the determination is adjusted to compensate for the absence of any components

38、 of the PERMANENT FILTRATION missing from the sample and normally located between the sample and the FOCAL SPOT. NOTE - The result of the determination is valid only for a particular combination of materials, as tested. In manufacture, the composition and thicknesses of materials actually used must

39、be controlled within appropriate limits, in order to maintain compliance with any stated value of PERMANENT FILTRATION. 4.2 Test sample Use a test sample, replicating, in accordance with 4.1, either the complete composition of layers of different materials, or a layer of an individual material, as u

40、sed in the construction of the X-RAY TUBE ASSEMBLY concerned to effect the whole or part of its PERMANENT FILTRATION. 4.3 Generation of the X-RAY BEAM for measurement To generate the X-RAY BEAM for measurement, use an X-RAY TUBE with a target of the same RIPPLE not exceeding 70 and a value chosen as

41、 follows: material as the X-RAY TUBE ASSEMBLY under test at an X-RAY TUBE VOLTAGE with a PERCENTAGE a) for X-RAY TUBE ASSEMBLIES in which the PERMANENT FILTRATION Contains a material With a K-edge absorption energy at 19 keV or above, use an X-RAY TUBE VOLTAGE corresponding to the K-edge energy of t

42、he material, for example 20 kV for molybdenum with a K-edge at 79,99 keV; otherwise b) for X-RAY TUBE ASSEMBLIES designed for a narrow range Of X-RAY TUBE VOLTAGE (e.9. CT-application), the NOMINAL X-RAY TUBE VOLTAGE; or for X-RAY TUBE ASSEMBLIES With a NOMINAL X-RAY TUBE VOLTAGE not exceeding 65 kV

43、, the NOMINAL X-RAY TUBE VOLTAGE; Or for X-RAY TUBE ASSEMBLIES With a NOMINAL X-RAY TUBE VOLTAGE exceeding 65 kV, 75 kV Or approximately half the NOMINAL X-RAY TUBE VOLTAGE, whichever is the greater. It S C) d) desirable to avoid testing close to the absorption edge of tungsten. For testing With a c

44、omposite sample, use an X-RAY BEAM With negligible TOTAL FILTRATION (e.9. a beryllium window). For testing with a sample of a single material, add an appropriate thickness of the reference material between the material under test and the FOCAL SPOT. This is of omitting any layers of material forming

45、 part of the actual PERMANENT FILTRATION. t0 Compensate for the effect on the RADIATION QUALITY at the ENTRANCE SURFACE Of the sample 4.4 RADIATION DETECTOR Use a RADIATION DETECTOR with a response that does not vary significantly over the energy range involved. 4.5 Composition of reference material

46、s this standard apply to reference materials of the following composition (designated by Cu 99,9 according IS0 2092): Values Of HALF-VALUE LAYER and QUALITY EQUIVALENT FILTRATION determined in accordance with - aluminium of 99,9 %O purity or higher and density 2,70 g m-; - copper of at least 99,9 %

47、purity or higher and a density of 8,90 g rn-. 4.6 Method of measurement Measure the first HALF VALUE LAYER Of the X-RAY BEAM under NARROW BEAM CONDITIONS, With the sample placed close to the FOCAL SPOT. Determine the thickness of the reference material SID-BSI BS EN b0522-ENLL 1799 lt29bb7 0782398 2

48、02 Page 7 EN 60522:1999 that is required to produce the same HALF VALUE LAYER under the same beam conditions. The sample. resulting thickness of the reference material is the QUALITY EQUIVALENT FILTRATION of the If the sample is a composite one, representing all the materials comprising the PERMANEN

49、T ASSEMBLY concerned. Alternatively, add the values obtained (with the same reference material and primary beam conditions) for the QUALITY EQUIVALENT FILTRATION of samples representing FILTRATION, the result is alS0 the value of the PERMANENT FILTRATION for the X-RAY TUBE all the different Single materials forming part Of the PERMANENT FILTRATION. Compliance With a stated Value of PERMANENT FILTRATION is achieved if the MEASURED VALUE determined in this test is not less than the stated value and does not exceed the stated value by more than 30 %. 5 Indications and stat