EN 61267-2006 en Medical diagnostic X-ray equipment C Radiation conditions for use in the determination of characteristics《医用诊断X射线设备-测定特性用辐射条件 IEC 61267-2005》.pdf

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1、BRITISH STANDARDBS EN 61267:2006Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristicsThe European Standard EN 61267:2006 has the status of a British StandardICS 11.040.50g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44

2、g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 61267:2006This British Standard was published under the authority of the Standards Policy and Strategy Committeeon 28 February 2006 BSI 28 February 2006ISBN 0 580 47911 0Nati

3、onal forewordThis British Standard is the official English language version of EN 61267:2006. It is identical with IEC 61267:2006. It supersedes BS EN 61267:1995 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical

4、 practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, 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, a

5、nd keep UK interests informed; monitor related international and European developments and promulgate them in the UK.A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European pu

6、blications referred to in this document may be found in the BSI Catalogueunder 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 ne

7、cessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 42, an inside b

8、ack cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARD EN 61267 NORME EUROPENNE EUROPISCHE NORM January 2006 CENELEC European Committee for Electrotechnical

9、Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61267

10、:2006 E ICS 11.040.50 Supersedes EN 61267:1994English version Medical diagnostic X-ray equipment Radiation conditions for use in the determination of characteristics (IEC 61267:2005) Equipement de diagnostic mdical rayonnement X Conditions de rayonnement pour utilisation dans la dtermination des car

11、actristiques (CEI 61267:2005) Medizinische diagnostische Rntgeneinrichtung Bestrahlungsbedingungen zur Bestimmung von Kenngren (IEC 61267:2005) This European Standard was approved by CENELEC on 2005-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate

12、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 to any CENELEC member. This European Standard exi

13、sts 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 official versions. CENELEC members are the national elec

14、trotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. F

15、oreword The text of document 62C/391/FDIS, future edition 2 of IEC 61267, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN

16、 61267 on 2005-12-01. This European Standard supersedes EN 61267:1994. The main changes compared to EN 61267:1994 include: a) introduction of “practical peak voltage” for measuring X-ray tube voltage; b) introduction of a new procedure for establishing the radiation qualities; c) inserting of an inf

17、ormative Annex B “Determination of the amount of additional filtration” and a normative Annex C “Measurement of the practical peak voltage”; d) revision of radiation qualities and radiation conditions; e) addition of term definitions. The following dates were fixed: latest date by which the EN has t

18、o be implemented at national level by publication of an identical national standard or by endorsement (dop) 2006-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2008-12-01 This European Standard makes reference to International Standards. Where th

19、e International Standard referred to has been endorsed as a European Standard or a home-grown European Standard exists, this European Standard shall be applied instead. Pertinent information can be found on the CENELEC web site. In this standard, the following print types are used: requirements prop

20、er: roman type; test specifications: italic type; notes and explanatory matter: small roman type; TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 61267:2005 was approve

21、d by CENELEC as a European Standard without any modification. _ EN 61267:2006 2 3 EN 61267:2006CONTENTSINTRODUCTION.41 Scope and object62 Normative references .93 Terms and definitions .94 Common aspects Adjustment procedures .115RQR RADIATION QUALITIES in RADIATION BEAMS emerging from the X-RAY SOU

22、RCE ASSEMBLY .126RQA RADIATION QUALITIES based on a PHANTOM made up of an aluminium ADDEDFILTER.157RQC RADIATION QUALITIES based on copper ADDED FILTER .178 RQT RADIATION QUALITIES based on copper ADDED FILTER189 Standard RADIATION CONDITIONS RQN 2010 Standard RADIATION CONDITIONS RQB 2211 Standard

23、RADIATION CONDITION RQR-M 2312 Standard RADIATION CONDITION RQA-M 2413 Standard RADIATION CONDITIONS RQN-M 2514 Standard RADIATION CONDITION RQB-M 26Annex A (informative) Rationale.34Annex B (informative) Determination of the amount of additional filtration .35ANNEX C (normative) Measurement of the

24、PRACTICAL PEAK VOLTAGE.37Annex D (informative) Overview of radiation qualities and radiation conditions 39Bibliography .40Index of defined terms 41EN 61267:2006 4 INTRODUCTIONTo establish characteristics, aspects or properties of ASSOCIATED EQUIPMENT or to have available RADIATION BEAMS for physical

25、 and medical investigations, sets of well-defined RADIATION CONDITIONS can offer an important tool in many situations. From a regulation and standardization point of view there is a need: to have available well-defined RADIATION CONDITIONS that can be used internationally to specify standards of ope

26、ration of X-RAY EQUIPMENT; to provide a basis for the harmonization of existing national standards; to provide uniform sets of RADIATION CONDITIONS (a dictionary of RADIATION CONDITIONS) to describe and judge the performance of X-RAY EQUIPMENT for the benefit of MANUFACTURERS, USERS, PATIENTS and he

27、alth protection authorities; to solve communication problems between MANUFACTURERS, USERS and regulatory authorities, stemming from a lack of internationally accepted definitions and test methods. From an application point of view, commonly accepted sets of RADIATION CONDITIONS would in general find

28、 use in: QUALITY CONTROL tests by MANUFACTURERS; installation and ACCEPTANCE TESTS; calibration of test instrumentation; type approval tests (where required); inspection and tests by regulatory authorities and testing institutes; physical and medical studies in physical laboratories and medical faci

29、lities; determination of characteristics of ASSOCIATED EQUIPMENT.Standard RADIATION CONDITIONS can benefit a number of potential users, such as: MANUFACTURERS of X-RAY EQUIPMENT; MANUFACTURERS of X-ray test instrumentation; research laboratories; testing institutes; USERS; government regulatory auth

30、orities; service organizations; standardization organizations. Some provisions and statements in the body of this International Standard require additional information. Such information is presented in Annex A called “Rationale“. An asterisk in the left-hand margin of a clause or subclause indicates

31、 the presence of such additional information. 5 EN 61267:2006In this standard the X-RAY TUBE VOLTAGE is measured as the PRACTICAL PEAK VOLTAGE. The rationale behind using this quantity is given in Annex C. A description of how the quantity PRACTICAL PEAK VOLTAGE is measured is given in Annex C. In t

32、he development of this edition of this standard efforts were made to set up procedures that give a high degree of equivalence of standard RADIATION QUALITIES realized on different X-ray machines. In the first edition the RADIATION QUALITIES were established by adjusting, within given limits the X-RA

33、Y TUBE VOLTAGE to such a value that the required HALF-VALUE LAYER was achieved. Depending on the total INHERENT FILTRATION an X-RAY TUBE VOLTAGE had to be selected which could differ from the nominal value by as much as r5 %. If the INHERENT FILTRATION of the X-RAY TUBE was relatively strong this co

34、uld be compensated by choosing a lower X-RAY TUBE VOLTAGe and vice versa. For the example of a radiation quality with a nominal X-RAY TUBE VOLTAGE of 100 kV this procedure meant that the tube voltage could be set as low as 95 kV for a moderately filtered RADIATION QUALITY and as high as 105 kV for a

35、 heavily filtered X-RAY TUBE. These two RADIATION QUALITIES were considered to be equivalent as long as they both had the required HALF-VALUE LAYER.This solution was not considered to be an ideal one. However, due to the lack of a suitable and agreed definition of what is usually termed peak voltage

36、 no alternative was available. With the arrival of the PRACTICAL PEAK VOLTAGE the situation has changed: With this quantity it is possible by means of an electrical measurement to set the tube voltage of the x-ray generator in question with any arbitrary shape of the ripple to a value that a radiogr

37、aph taken with a tube connected to this generator has the same low level contrast as a radiograph taken with the same x-ray tube connected to a true constant potential generator operating at the correct voltage. Given the possibility of setting the tube voltage of any generator to the correct value,

38、 irrespective of the shape of the ripple, it becomes difficult to justify the deliberate selection of a wrong tube voltage to compensate for a below or an above average filtration of the x-ray tube. The procedure, by which the radiation qualities are realized in this second edition, consists of sett

39、ing the X-RAY TUBE VOLTAGE to the correct value and determining the amount of filtration needed to produce the required HALF-VALUE LAYER. The nature of this process implies that there is a certain maximum total INHERENT FILTRATION beyond which a given X-RAY TUBE may no longer be used to produce a gi

40、ven RADIATION QUALITY. This is not new in principle, but it is clearly expressed in this edition. In order not to exclude what are considered as standard X-RAY TUBES, the HALF-VALUE LAYERS of some of the RADIATION QUALITIES have been increased. The new HALF-VALUE LAYERS have been chosen in such a wa

41、y that it is possible to establish all RADIATION QUALITIES in this standard with an X-RAY TUBE with 2,5 mm Al hardening-equivalent filtration and with ANODE ANGLES down to 9. The procedure to be followed according to this edition for producing the RADIATION QUALITIESof the RQR series does require a

42、certain amount of additional effort. This additional effort is largely compensated when the more heavily filtered radiation qualities are realized. The great advantage of the new method lies in a much higher degree of equivalence of a given RADIATION QUALITY with X-RAY TUBES having different INHEREN

43、T FILTRATIONS.EN 61267:2006 6 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS 1 Scope and object This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnost

44、ic X-RAY EQUIPMENT, require well-defined RADIATION CONDITIONS.Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the RADIATION BEAM (for example by rare earth filters). RADIATION C

45、ONDITIONS as used for screen-film sensitometry are not covered in this standard. NOTE Screen-film sensitometry is the subject of the ISO 9236 series. This standard deals with methods for generating RADIATION BEAMS with RADIATION CONDITIONSwhich can be used under test conditions typically found in te

46、st laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-RAY EQUIPMENT.Examples of such RADIATION QUALITIES are RADIATION BEAMS emerging through the filtration from the X-RAY SOURCE ASSEMBLY. RADIATION CONDITIONS represent the more general case,

47、 where SCATTERED RADIATION emerges from an EXIT SURFACE of a PATIENT or a PHANTOM. This requires a well defined geometrical arrangement. The most complete specification of RADIATION FIELDS is given by the spectral distribution of the photon fluence. Since the measurement of X-RAY SPECTRA is a demand

48、ing task, this standard expresses RADIATION QUALITIES in terms of the X-RAY TUBE VOLTAGE, the first and second HALF-VALUE LAYER. In the case of RADIATION CONDITIONS, specifications are performed additionally in terms of PHANTOM properties and geometry. The attempt to characterize a spectral distribu

49、tion just by means of the X-RAY TUBE VOLTAGE,the first and possibly the second HALF-VALUE LAYER is thus a compromise between the mutually conflicting requirements of avoiding excessive efforts for establishing a RADIATIONQUALITY and of the complete absence of any ambiguity in the definition of a RADIATION QUALITY. Due to differences in the design and the age of X-RAY TUBES in terms of anode angle, anode roughening and INHERENT FILTRAT