BS-EN-60336-2005.pdf
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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 It supersedes BS EN 60336:1995 which will be withdrawn on 1 June 2008.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
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