BS-EN-62220-1-2004.pdf
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1、BRITISH STANDARD BS EN 62220-1:2004 Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1: Determination of the detective quantum efficiency The European Standard EN 62220-1:2004 has the status of a British Standard ICS 11.040.50 ? Licensed Copy: sheffieldun sheffieldu
2、n, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 62220-1:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 2 February 2004 BSI 2 February 2004 ISBN 0 580 43335 8 National foreword This British Standard is the off
3、icial English language version of EN 62220-1:2004. It is identical with IEC 62220-1:2003. 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 equipment, which has the responsibil
4、ity 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 under the section entitled “Inter
5、national 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 application. Compliance with a Br
6、itish 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 the UK interests informed; monitor related international
7、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 29 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issue
8、d since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 62220-1 NORME EUROPENNE EUROPISCHE NORM January 2004 CENELEC European Committee for Electrotechnical Standardization Comit Europen
9、 de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62220-1:2004 E ICS 11.040.50 Engli
10、sh version Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003) Appareils lectromdicaux - Caractristiques des appareils dimagerie rayonnement X Part 1: Dtermination de lefficacit quantique de dtecti
11、on (CEI 62220-1:2003) Medizinische elektrische Gerte - Merkmale digitaler Rntgenbildgerte Teil 1: Bestimmung der detektiven Quanten-Ausbeute (IEC 62220-1:2003) This European Standard was approved by CENELEC on 2003-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations
12、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 concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This Europ
13、ean 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 into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are t
14、he national electrotechnical committees of Austria, Belgium, 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 Ki
15、ngdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of document 62B/493/FDIS, future edition 1 of IEC 62220-1, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was
16、 submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62220-1 on 2003-12-01. 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) 2004-09-01 latest date by
17、which the national standards conflicting with the EN have to be withdrawn (dow) 2006-12-01 In this standard, terms printed in SMALL CAPITALS are used as defined in IEC 60788, in Clause 3 of this standard or other IEC publications referenced in Annex B. Where a defined term is used as a qualifier in
18、another defined or undefined term it is not printed in SMALL CAPITALS, unless the concept thus qualified is defined or recognized as a “derived term without definition“. NOTE Attention is drawn to the fact that, in cases where the concept addressed is not strongly confined to the definition given in
19、 one of the publications listed above, a corresponding term is printed in lower-case letters. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62220-1:2003 was approved by CENELEC as a European Standard without any modification. In the official vers
20、ion, for Bibliography, the following note has to be added for the standard indicated: IEC 61262-5 NOTE Harmonized as EN 61262-5:1994 (not modified). _ Page 2 EN 622201:2004 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CONTENTS INTRODUCTIO
21、N.4 1 Scope.5 2 Normative references .5 3 Terminology and definitions6 4 Requirements.7 4.1 Operating conditions .7 4.2 X-RAY EQUIPMENT .7 4.3 RADIATION QUALITY .8 4.4 TEST DEVICE.9 4.5 Geometry 10 4.6 IRRADIATION conditions 12 4.6.1 General conditions 12 4.6.2 Exposure measurement.12 4.6.3 Avoidanc
22、e of LAG EFFECTS13 4.6.4 IRRADIATION to obtain the CONVERSION FUNCTION 13 4.6.5 IRRADIATION for determination of the NOISE POWER SPECTRUM13 4.6.6 IRRADIATION with TEST DEVICE in the RADIATION BEAM.14 5 Corrections of RAW DATA .15 6 Determination of the DETECTIVE QUANTUM EFFICIENCY 15 6.1 Definition
23、and formula of DQE (u,v).15 6.2 Parameters to be used for evaluation 16 6.3 Determination of different parameters from the images16 6.3.1 Linearization of data16 6.3.2 The NOISE POWER SPECTRUM (NPS).17 6.3.3 Determination of the MODULATION TRANSFER FUNCTION (MTF)19 7 Format of conformance statement
24、19 8 Accuracy 20 Annex A (normative) Determination of LAG EFFECTS22 A.1 Test of additive LAG EFFECTS22 A.2 Test of multiplicative LAG EFFECTS23 Annex B (normative) Terminology Index of defined terms25 Annex C (informative) Calculation of the input NOISE POWER SPECTRUM 26 Annex ZA (normative) Normati
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