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1、BRITISH STANDARD BS EN 60336:2005 Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots The European Standard EN 60336:2005 has the status of a British Standard ICS 11.040.50 ? Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00
2、 2006, Uncontrolled Copy, (c) BSI BS EN 60336:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 October 2005 BSI 13 October 2005 ISBN 0 580 46478 4 National foreword This British Standard is the official English language version of EN 6
3、0336:2005. It is identical with IEC 60336:2005. It supersedes BS EN 60336:1995 which will be withdrawn on 1 June 2008. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/2, Diagnostic imaging equipme
4、nt, which has the responsibility to: A list of organizations represented on this subcommittee 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 in the BSI Catalogue unde
5、r 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 responsible for its correct appl
6、ication. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monit
7、or 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 39 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last
8、 issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 60336 NORME EUROPENNE EUROPISCHE NORM July 2005 CENELEC European Committee for Electrotechnical Standardi
9、zation Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60336:2005 E I
10、CS 11.040.50 Supersedes EN 60336:1995 English version Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots (IEC 60336:2005) Appareils lectromdicaux Gaines quipes pour diagnostic mdical - Caractristiques des foyers (CEI 60336:2005) Medizinische elekt
11、rische Gerte - Rntgenstrahler fr medizinische Diagnostik Kennwerte von Brennflecken (IEC 60336:2005) This European Standard was approved by CENELEC on 2005-06-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Sta
12、ndard 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 (English, Fr
13、ench, 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 Austria, Belgium
14、, 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. Licensed Copy: sheffieldun sheffieldun, na,
15、Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60336:2005 - 2 - Foreword The text of document 62B/554/FDIS, future edition 4 of IEC 60336, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC par
16、allel vote and was approved by CENELEC as EN 60336 on 2005-06-01. This European Standard supersedes EN 60336:1995. 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) 2006-03-01 l
17、atest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2008-06-01 Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60336:2005 was approved by CENELEC as a European Standard without any modification. In the offi
18、cial version, for Bibliography, the following note has to be added for the standard indicated: IEC 60601-2-28 NOTE Harmonized as EN 60601-2-28:1993 (not modified). _ Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 EN 60336:2005 CONTENTS 1
19、Scope 5 2 Normative references .5 3 Terms and definitions .5 4 Determinations for the evaluation of the FOCAL SPOT characteristics .5 4.1 Statement of the FOCAL SPOT characteristics.5 4.2 Longitudinal axis of the X-RAY TUBE ASSEMBLY.5 4.3 REFERENCE AXIS of the X-RAY TUBE ASSEMBLY6 4.4 Direction of e
20、valuation for the FOCAL SPOT length6 4.5 Direction of evaluation for the FOCAL SPOT width .6 5 FOCAL SPOT camera set-up 6 5.1 Overview.6 5.2 Test equipment6 5.3 Test arrangement 8 5.4 Total uncertainty of the camera set-up .11 6 Production of RADIOGRAMS11 6.1 Overview.11 6.2 Operating conditions11 6
21、.3 Production of FOCAL SPOT SLIT RADIOGRAMS or FOCAL SPOT PINHOLE RADIOGRAMS.12 6.4 Statement of compliance13 7 Determination of the LINE SPREAD FUNCTION.13 7.1 Overview.13 7.2 Measuring equipment and measuring arrangement.13 7.3 Measurement of the density distribution .14 7.4 Determination of the L
22、INE SPREAD FUNCTION14 7.5 Statement of compliance14 8 Determination of FOCAL SPOT dimensions.15 8.1 Overview.15 8.2 Measurement and determination 15 8.3 Specified NOMINAL FOCAL SPOT VALUES16 8.4 Statement of compliance18 8.5 Marking of compliance.18 9 Determination of the MODULATION TRANSFER FUNCTIO
23、N18 9.1 Overview.18 9.2 Specified MODULATION TRANSFER FUNCTION18 9.3 Calculation of the MODULATION TRANSFER FUNCTION.19 9.4 Evaluation of compliance of the MTF20 9.5 Statement of compliance20 10 FOCAL SPOT STAR RADIOGRAMS.20 10.1 Overview.20 10.2 Test equipment21 11 STAR PATTERN RESOLUTION LIMIT.23
24、11.1 Overview.23 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60336:2005 4 11.2.Specified STAR PATTERN RESOLUTION LIMIT 23 11.3 Measurement 24 11.4 Determination of the STAR PATTERN RESOLUTION LIMIT24 11.5 Evaluation and statement of c
25、ompliance.25 12 BLOOMING VALUE26 12.1 Overview.26 12.2 Determination of the BLOOMING VALUE.26 12.3 Evaluation and statement of compliance.26 13 Alternate measurement methods.27 Annex A (informative) Alignment to the REFERENCE AXIS28 Annex B (informative) Application of digital X-ray image detectors
26、for determination of the FOCAL SPOT characteristics 30 Annex C (informative) Historical background 31 Bibliography .36 Index of defined terms 37 Figure 1 Essential dimensions of the slit diaphragm7 Figure 2 Essential dimensions of the pinhole diaphragm .8 Figure 3 Position of the centre of the slit
27、or pinhole diaphragm (marked as x in the figure) with respect to the REFERENCE AXIS.9 Figure 4 Reference dimensions and planes 10 Figure 5 Alignment of the optical densitometer slit 14 Figure 6 LINE SPREAD FUNCTION.15 Figure 7 Essential dimensions of the star test pattern .21 Figure 8 Essential dime
28、nsions of the star test pattern .22 Figure 9 Illustration of the zones of minimum modulation 24 Figure A.1 The REFERENCE AXIS and directions of evaluation .28 Figure A.2 Projection of the ACTUAL FOCAL SPOT on the IMAGE RECEPTION PLANE.29 Figure C.1 The LSFs for a typical X-RAY TUBE with small FOCAL
29、SPOT ( 3 0,4 2 1,1 f E 1 a See 8.3. b See Figure 4. 5.4 Total uncertainty of the camera set-up The uncertainty in the FOCAL SPOT measurement contributed by the set-up of the FOCAL SPOT camera shall not exceed 5 %. 6 Production of RADIOGRAMS 6.1 Overview This clause deals with production of FOCAL SPO
30、T SLIT RADIOGRAMS and FOCAL SPOT PINHOLE RADIOGRAMS. A method of indicating compliance with this standard of FOCAL SPOT SLIT RADIOGRAMS and FOCAL SPOT PINHOLE RADIOGRAMS is included. 6.2 Operating conditions 6.2.1 FOCAL SPOT SLIT RADIOGRAMS and FOCAL SPOT PINHOLE RADIOGRAMS FOCAL SPOT SLIT RADIOGRAM
31、S and FOCAL SPOT PINHOLE RADIOGRAMS shall be produced using a FOCAL SPOT camera according to Clause 5. Requirements for determining FOCAL SPOT dimensions from FOCAL SPOT SLIT RADIOGRAMS are described in Clause 8; requirements for determining the MODULATION TRANSFER FUNCTION are described in Clause 9
32、. FOCAL SPOT PINHOLE RADIOGRAMs are used only for showing the orientation, the symmetry and the distribution of radiant intensity over the FOCAL SPOT. 6.2.2 X-RAY TUBE ASSEMBLY The X-RAY TUBE shall be installed in an X-RAY TUBE HOUSING of the type for which it is specified for NORMAL USE or it shall
33、 be placed under equivalent mounting and operating conditions as far as these can influence the results of the test. No ADDITIONAL FILTRATION shall be used to decrease the X-ray output flux unless it is verified that the ADDITIONAL FILTRATION has no significant effect on the LINE SPREAD FUNCTION. Ho
34、wever, all the materials belonging to the X-RAY TUBE ASSEMBLY in NORMAL USE shall be installed. 6.2.3 LOADING FACTORS FOCAL SPOT SLIT RADIOGRAMS or FOCAL SPOT PINHOLE RADIOGRAMS for X-ray tube assemblies used in projection radiography or in COMPUTED TOMOGRAPHY shall be obtained with constant LOADING
35、 FACTORS in accordance with Table 2. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60336:2005 12 For ROTATING ANODE X-RAY TUBEs, the ANODE shall be rotated at the highest ANODE SPEED specified in the applicable RADIOGRAPHIC RATINGs. Tab
36、le 2 LOADING FACTORS NOMINAL X-RAY TUBE VOLTAGE kV Required X-RAY TUBE VOLTAGE Exposure time Required X-RAY TUBE power U 75 NOMINAL X-RAY TUBE VOLTAGE 75 U 150 75 kV RADIOGRAPHY other than COMPUTED TOMOGRAPHY 150 U 200 50 % of the NOMINAL X-RAY TUBE VOLTAGE COMPUTED TOMOGRAPHY 120 kV As required to
37、meet the optical density requirement, see 6.3.3 50 % of the NOMINAL ANODE INPUT POWER as specified by IEC 60613 6.2.4 Special LOADING FACTORS If the LOADING FACTORs according to Table 2 do not fall within the RADIOGRAPHIC RATINGs for the X-RAY TUBE concerned or if they otherwise do not cover the typ
38、ical special applications of specified NORMAL USE of the X-RAY TUBE, LOADING FACTORs shall be chosen to correspond to those specific conditions. In this case, the LOADING FACTORs under which the FOCAL SPOT SLIT RADIOGRAMs or FOCAL SPOT PINHOLE RADIOGRAMs were obtained shall be stated together with t
39、he characteristics. In particular cases, it may be appropriate to state the characteristics of a FOCAL SPOT under multiple LOADING conditions. 6.2.5 Special arrangements If, for the purpose of production of suitable FOCAL SPOT RADIOGRAMs, special arrangements were made for the adjustment and alignme
40、nt of either the SLIT CAMERA and X-RAY TUBE ASSEMBLY or if special electrical or LOADING conditions prevailed, details shall be stated together with the characteristics in the statement of compliance. 6.3 Production of FOCAL SPOT SLIT RADIOGRAMS or FOCAL SPOT PINHOLE RADIOGRAMS 6.3.1 Production of F
41、OCAL SPOT SLIT RADIOGRAMS A pair of FOCAL SPOT SLIT RADIOGRAMs shall be made with the operating conditions described in 6.2. 6.3.2 Production of FOCAL SPOT PINHOLE RADIOGRAMS FOCAL SPOT PINHOLE RADIOGRAMs shall be made with the operating conditions described in 6.2. 6.3.3 RADIOGRAPHIC FILM exposure
42、The RADIOGRAPHIC FILM shall be exposed so that, after development, a local diffuse density between 1,0 and 1,4 is obtained in areas of greatest blackening. The blackening of the film due to fog and base shall not exceed a diffuse density of 0,25. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 0
43、9 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 13 EN 60336:2005 6.4 Statement of compliance If compliance with this standard is to be stated for a pair of FOCAL SPOT SLIT RADIOGRAMs or for a FOCAL SPOT PINHOLE RADIOGRAM, it shall be stated as follows: FOCAL SPOT SLIT RADIOGRAM with enlargemen
44、t of.2) according to IEC 60336 or FOCAL SPOT PINHOLE RADIOGRAM with enlargement of 3) according to IEC 60336 and as appropriate: Subclause REFERENCE AXIS 4.3 LOADING FACTORS 6.2.3 Special arrangements 6.2.5 Description of the longitudinal axis of the X-RAY TUBE ASSEMBLY 4.2 7 Determination of the LI
45、NE SPREAD FUNCTION 7.1 Overview This clause deals with the determination of a pair of LINE SPREAD FUNCTIONS to be used for the determination of FOCAL SPOT dimensions in accordance with Clause 8 and the determination of the MODULATION TRANSFER FUNCTION in accordance with Clause 9. These LINE SPREAD F
46、UNCTIONs shall be deduced from FOCAL SPOT SLIT RADIOGRAMs. A method of indicating compliance with this standard of a pair of LINE SPREAD FUNCTIONS is included. 7.2 Measuring equipment and measuring arrangement The FOCAL SPOT SLIT RADIOGRAMs obtained in accordance with Clause 5 and Clause 6 shall be
47、scanned by means of an optical densitometer. The aperture of the optical densitometer shall have a width b not exceeding the width of the slit diaphragm used for the production of the FOCAL SPOT SLIT RADIOGRAMs. The length of the aperture of the optical densitometer shall be limited, so that it can
48、be aligned with the direction of the diaphragm slit projected on the RADIOGRAM in such a way that the effective width beff of the optical densitometer aperture normal to the direction of the projected diaphragm slit will be smaller than twice the width b of the optical densitometer aperture, as show
49、n in Figure 5. 2) Enlargement used and determined in accordance with Clause 5. 3) Enlargement used and determined in accordance with Clause 5. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:06:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60336:2005 14 b beff Longitudinal direction of the diaphragm slit projected on the RADIOGRAM Direction of the optical densitometer aperture Scanni