1、BRITISH STANDARD BS EN 60522:1999 IEC 60522: 1999 Determination of the permanent filtration of X-ray tube assemblies The European Standard EN 60522:1999 has the status of a British Standard ICS 11.040.50BSEN60522:1999 This British Standard, having been prepared under the directionof the Health and E
2、nvironment Sector Committee, was published under the authorityof the Standards Committee and comes into effect on 15June1999 BSI 03-2000 ISBN 0 580 32601 2 National foreword This British Standard is the English language version of EN60522:1999. It is identical with IEC60522:1999. The UK participatio
3、n in its preparation was entrusted to Technical Committee CH/71, Diagnostic imaging equipment and accessories, 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 chan
4、ge, and keep the UK interests informed; 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. From 1January1997, all IEC publications have the number60000 added to the
5、old number. For instance, IEC27-1 has been 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 that CEN and CENELEC Standards normally inc
6、lude an annex which lists normative references to international publications with their corresponding 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 Standa
7、rds Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. 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 Standar
8、d does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages 2 to 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amen
9、dments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN60522:1999 BSI 03-2000 i Contents Page National foreword Inside front cover Foreword 2 Text of EN60522 3ii blankEUROPEAN STANDARD NORME EUROPENN
10、E EUROPISCHE NORM EN 60522 April 1999 ICS 11.040.50 English version Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999) Dtermination de la filtration permanentedesgaines quipes (CEI60522:1999) Ermittlung der Eigenfilterung vonRntgenstrahlern (IEC 60522:1999) This Euro
11、pean Standard was approved by CENELEC on1999-04-01. 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
12、 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, French, German). A version in any other language made by translation under the responsibility of a CENELEC member
13、 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, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,
14、Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1999 CENELECAll ri
15、ghts of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60522:1999EEN60522:1999 BSI 03-2000 2 Foreword The text of document62B/359/FDIS, future edition2 of IEC60522, prepared bySC62B, Diagnostic imaging equipment, of IECTC62, Electrical equipment in medi
16、cal practice, was submitted to the IEC-CENELEC parallel vote andwas approved by CENELEC as EN60522 on1999-04-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. In this standard,Annex A andAnnex ZA are normative. Annex ZA has been added by CENELEC
17、. Endorsement notice The text of the International Standard IEC60522:1999 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 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 t
18、erms 3 3.3 Defined terms 4 4 Measurement of PERMANENT FILTRATION 4 4.1 General 4 4.2 Test sample 4 4.3 Generation of the X-RAY BEAM for measurement 4 4.4 RADIATION DETECTOR 5 4.5 Composition of reference materials 5 4.6 Method of measurement 5 5 Indications and statements of PERMANENT FILTRATION 5 A
19、nnex A (normative) Terminology Index of defined terms 6 Annex ZA (normative) Normative references to international publications with their corresponding European publications Inside back cover latest date by which the EN has to be implemented at national level by publication of an identical national
20、 standard or by endorsement (dop)2000-01-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow)2002-04-01EN60522:1999 BSI 03-2000 3 1 Scope and object 1.1 Scope This International Standard applies to X-RAY TUBE ASSEMBLIES for medical diagnosis and RADIOTHER
21、APY. 1.2 Object This standard defines the concept of PERMANENT FILTRATION in X-RAY TUBE ASSEMBLIES for 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 X-RAY TUBE ASSE
22、MBLIES. Methods are given to determine the 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 1This standard does not contain requirements for any spec
23、ific values of PERMANENT FILTRATION or TOTAL FILTRATION to be provided. For X-RAY TUBE ASSEMBLIES and X-RAY EQUIPMENT used for diagnostic purposes, appropriate requirements are given in IEC60601-1-3. NOTE 2The method of determination described in this standard is suitable as a type test. It is not i
24、ntended 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 editions indicated were valid. All normative documents
25、 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 ISO maintain registers of currently valid International Standards
26、. IEC 60601-1:1988, Medical electrical equipmentPart1: General requirements for safety. Amendment No. 1 (1991) Amendment No. 2 (1995) IEC 60601-1-3:1994, Medical electrical equipmentPart1: General requirements for safety3.Collateral Standard: General requirements for radiation protection in diagnost
27、ic X-ray equipment. IEC 60788:1984, Medical radiologyTerminology. ISO 2092:1981, Light metals and their alloysCode of designation based on chemical symbols. 3 Terminology 3.1 Degree of requirements In this standard, certain terms which are not printed in SMALL CAPITALS have particular meanings, as f
28、ollows: 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions in this standard, in IEC60601-1, or in IEC60788. NOTEWhere terms having definitions in the publication listed above are not printed in small capitals, the definitions do not apply
29、 and the meaning is determined by the context. “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 need to comply; “spe
30、cific” 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 MANUFACTURER in
31、ACCOMPANYING DOCUMENTS or in other documentation relating to the equipment under consideration, usually concerning its intended purposes, or the parameters or conditions associated with its use or with testing to determine compliance.EN60522:1999 4 BSI 03-2000 An index of defined terms used in this
32、standard is given inAnnex A. 3.3 Defined terms For the purpose of this standard, the following additional definition applies. 3.3.1 PERMANENT FILTRATION the QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed materials intercepting the X-RAY BEAM, that are not inten
33、ded 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 with the requirements in clause5, the PERMANENT FILTRATION is to be expressed in terms of the actual filtering material (e.g.beryllium), the natur
34、e and thickness of the material present shall be determined or verified by inspection. In other cases, the following test shall be used to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY to be indicated or stated in accordance with this standard. 4.1 General The PERMANENT FILTRATION is
35、determined by measuring the QUALITY EQUIVALENT FILTRATION of samples of the permanently fixed materials, used in the construction of the X-RAY TUBE ASSEMBLY, that intercept the X-RAY BEAM. Where appropriate, a composite sample replicating the combination of the various materials and their thicknesse
36、s, as actually used in the construction, can be tested. Alternatively, the PERMANENT FILTRATION can be computed from measurements on samples of the individual materials concerned, provided that: the reference material is the same for each sample and, the RADIATION QUALITY of the X-RAY BEAM used for
37、the determination is adjusted to compensate for the absence of any components of the PERMANENT FILTRATION missing from the sample and normally located between the sample and the FOCAL SPOT. NOTEThe result of the determination is valid only for a particular combination of materials, as tested. In man
38、ufacture, the composition and thicknesses of materials actually used must 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 with4.1, either the complete composition of
39、layers of different materials, or a layer of an individual material, as used 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 TUB
40、E with a target of the same material as the X-RAY TUBE ASSEMBLY under test at an X-RAY TUBE VOLTAGE with a PERCENTAGE RIPPLE not exceeding10 and a value chosen as follows: a) for X-RAY TUBE ASSEMBLIES in which the PERMANENT FILTRATION contains a material with a K-edge absorption energy at19 keV or a
41、bove, use an X-RAY TUBE VOLTAGE corresponding to the K-edge energy of the material, for example20kV for molybdenum with a K-edge at19,99 keV; otherwise b) for X-RAY TUBE ASSEMBLIES designed for a narrow range of X-RAY TUBE VOLTAGE (e.g.CT-application), the NOMINAL X-RAY TUBE VOLTAGE; or c) for X-RAY
42、 TUBE ASSEMBLIES with a NOMINAL X-RAY TUBE VOLTAGE not exceeding65kV, the NOMINAL X-RAY TUBE VOLTAGE; or d) for X-RAY TUBE ASSEMBLIES with a NOMINAL X-RAY TUBE VOLTAGE exceeding65kV,75kV or approximately half the NOMINAL X-RAY TUBE VOLTAGE, whichever is the greater. It is desirable to avoid testing
43、close to the absorption edge of tungsten. For testing with a composite sample, use an X-RAY BEAM with negligible TOTAL FILTRATION (e.g.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 F
44、OCAL SPOT. This is to compensate for the effect on the RADIATION QUALITY at the ENTRANCE SURFACE of the sample of omitting any layers of material forming part of the actual PERMANENT FILTRATION.EN60522:1999 BSI 03-2000 5 4.4 RADIATION DETECTOR Use a RADIATION DETECTOR with a response that does not v
45、ary significantly over the energy range involved. 4.5 Composition of reference materials Values of HALF-VALUE LAYER and QUALITY EQUIVALENT FILTRATION determined in accordance with this standard apply to reference materials of the following composition (designated by Cu99,9 according ISO2092): alumin
46、ium of99,9% purity or higher and density 2,70gcm 3 ; copper of at least99,9% purity or higher and a density of8,90gcm 3 . 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 thickne
47、ss of the reference material that is required to produce the same HALF VALUE LAYER under the same beam conditions. The resulting thickness of the reference material is the QUALITY EQUIVALENT FILTRATION of the sample. If the sample is a composite one, representing all the materials comprising the PER
48、MANENT FILTRATION, the result is also the value of the PERMANENT FILTRATION for the X-RAY TUBE ASSEMBLY concerned. Alternatively, add the values obtained (with the same reference material and primary beam conditions) for the QUALITY EQUIVALENT FILTRATION of samples representing all the different sin
49、gle 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 than30%. 5 Indications and statements of PERMANENT FILTRATION For statements of compliance with this standard, the value of the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY shall be expressed in millimetres the thickness of: the material concerned, if the PERMANENT FILTRATION consists o
