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    BS EN 61223-3-4-2000 Evaluation and routine testing in medical imaging departments Acceptance tests《医疗成像部门的评定及例行检查 验收检验》.pdf

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    BS EN 61223-3-4-2000 Evaluation and routine testing in medical imaging departments Acceptance tests《医疗成像部门的评定及例行检查 验收检验》.pdf

    1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 61223-3-4:2000 IEC

    2、61223-3-4:2000 The European Standard EN 61223-3-4:2000 has the status of a British Standard ICS 11.040.50; 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Evaluation and routine testing in medical imaging departments Part 3-4: Acceptance tests - Imaging performance o

    3、f dental X-ray equipmentThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 BSI 12-2000 ISBN 0 580 36149 7 BS EN 61223-3-4:2000 Amendment

    4、s issued since publication Amd. No. Date Comments National foreword This British Standard is the official English language version of EN 61223-3-4:2000. It is identical with IEC 61223-3-4:2000. The UK participation in its preparation was entrusted to Technical Committee CH/73, X-ray equipment compon

    5、ents, protection and utilization, 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, and keep the UK interests informed; monitor related international and Eur

    6、opean developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For

    7、 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 include an annex which lists normative references to international publicat

    8、ions 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 Standards Correspondence Index”, or by using the “Find” facility of the BSI St

    9、andards 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 Standard does not of itself confer immunity from legal obligations. Summary of

    10、pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 35 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.Page 2 EN 61223-3-4:2000%6, 5$(48,30(17ZLWKLQWUDRUDO; 5$,0$*(5( 5$78%(92/7$*( 7 27$/)

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    12、UDSK $QQH=$QRUPDWLYH1RUPDWLYHUHIHUHQFHVWRLQWHUQDWLRQDOSXEOLFDWLRQVZLWK WKHLU FRUUHVSRQGLQJ (XURSHDQ SXEOLFDWLRQV )LJXUHHQWDO; 5$(48,30(17ZLWKLQWUDRUDO; 5$,0$*(5( 5$(48,30(17ZLWKLQWUDRUDO; 5$,0$*(5( 5$(48,30(17ZLWKHWUDRUDO; 5$,0$*(5( 5$(48,30(17ZLWKHWUDRUDOGLJLWDO; 5$ ,0$*(5( 5$(48,30(17ZLWKHWUDRUDO;

    13、 5$ ,0$*(5( 5$,0$*(5( 5$(48,30(17ZLWKHWUDRUDO; 5$,0$*( 5( 5$(48,30(17RUFHSKDORPHWULF; 5$ 7KLVVWDQGDUGDSSOLHVWRGHQWDOILOPDQGGLJLWDOLPDJHDFTXLVLWLRQDQGSURFHVVLQJ 2EMHFW 7KLVVWDQGDUGGHILQHV D WKHHVVHQWLDOSDUDPHWHUVZKLFKGHVFULEHWKHSHUIRUPDQFHRIWKHDERYHPHQWLRQHGGHQWDO ; 5$(48,30(17ZLWKUHJDUGWRLPDJLQJSURS

    14、HUWLHVDQG 3$7,(17GRVH E PHWKRGVRIWHVWLQJDQGZKHWKHUPHDVXUHGTXDQWLWLHVUHODWHGWRWKRVHSDUDPHWHUVFRPSO ZLWKWKHVSHFLILHGWROHUDQFHV 7KHVHPHWKRGVUHOPDLQORQQRQLQYDVLYHPHDVXUHPHQWVXVLQJDSSURSULDWHWHVWHTXLSPHQW SHUIRUPHGGXULQJRUDIWHUWKHLQVWDOODWLRQLVFRPSOHWHG6LJQHGVWDWHPHQWVFRYHULQJVWHSVLQ WKHLQVWDOODWLRQSURFH

    15、GXUHPDEHXVHGDVSDUWRIWKHDFFHSWDQFHWHVWLQJ 7KHDLPLVWRYHULIFRPSOLDQFHRIWKHLQVWDOODWLRQZLWKVSHFLILFDWLRQVDIIHFWLQJWKHLPDJH TXDOLWDQG 3$7,(17GRVHDQGWRGHWHFWPDOIXQFWLRQVWKDWDUHQRWLQDJUHHPHQWZLWKWKRVH VSHFLILFDWLRQV 7KLVVWDQGDUGGRHVQRWLQLWVHOIVSHFLIWROHUDQFHVIRUWKHSDUDPHWHUVXQGHULQYHVWLJDWLRQ 1HLWKHULVLWLQ

    16、WHQGHGWRFRQVLGHU F DVSHFWVRIPHFKDQLFDODQGHOHFWULFDOVDIHW G DVSHFWVRIPHFKDQLFDOHOHFWULFDODQGVRIWZDUHSHUIRUPDQFHXQOHVVWKHDUHHVVHQWLDOWR WKHSHUIRUPDQFHRIWKHWHVWVGLUHFWODIIHFWLQJLPDJHTXDOLWDQG 3$7,(17GRVH Page 6 EN 61223-3-4:2000%6, 1RUPDWLYHUHIHUHQFHV 7KHIROORZLQJQRUPDWLYHGRFXPHQWVFRQWDLQSURYLVLRQVZKLF

    17、KWKURXJKUHIHUHQFHLQWKLVWHW FRQVWLWXWH SURYLVLRQV RI WKLV SDUW RI ,(UDWXEHDVVHPEOLHVIRUPHGLFDOGLDJQRVLVUDWXEHDVVHPEOLHV ,(UDVRXUFHDVVHPEOLHVDQG;UDWXEHDVVHPEOLHVIRUPHGLFDOGLDJQRVLV ,(UDHTXLSPHQW5DGLDWLRQFRQGLWLRQVIRUXVHLQWKH GHWHUPLQDWLRQRIFKDUDFWHULVWLFV ,62 /LJKWPHWDOVDQGWKHLUDOORV 5$(48,30(17$VXLWD

    18、EOHWHVWSURFHGXUHLVJLYHQLQDQQH 5$(48,30(17WHVWHGLGHQWLILFDWLRQ RIWKHWHVWHTXLSPHQWXVHGJHRPHWULFDOVHWXSRSHUDWLQJFKDUDFWHULVWLFVFRUUHFWLRQIDFWRUV DQGWHVWUHVXOWVRIWKH $662 5$(48,30(17 FKHFNRIGRFXPHQWV YLVXDODQGIXQFWLRQDOWHVWV ; 5$78%(92/7$*( 727$/),/75$7,21 )2 5$%($0 /,1(3$,55(62/87,21 /2: 5$ 78%( 92/7$*

    19、( VKRXOG EH PHDVXUHG E D UDGLRJUDSKLF SHQHWUDPHWHU 127( ,ILWLVQHFHVVDUWRXVHDQHOHFWURQLFKLJKYROWDJHPHDVXULQJLQVWUXPHQWWKH 86(5VKRXOGHYDOXDWHWKH VLJQLILFDQFHRIDQGHYLDWLRQEHWZHHQWKH ,1, 5$(48,30(17WKHUHLVDYDULDWLRQRI; 5$78%(92/7$*( DWWKH EHJLQQLQJRIWKH /2$,1*7,0(ZKLFKLVRIQRFOLQLFDOFRQVHTXHQFH 6RPHSDQRU

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    21、QHUJDQGORZHU $,5 .(50$5$7(6WKDQJHQHUDOPHGLFDOUDGLRJUDSK,WVKDOOEHHQVXUHGWKDWWKH .(50$0(7(5 XVHGIRUWKHVHWHVWVLVVXLWDEOHIRUWKHSXUSRVHDQGFDOLEUDWHGIRUWKHHQHUJDQG .(50$5$7( LQXVHDQGWKDWWKHGHWHFWRULVVPDOOHUWKDQWKHQRPLQDWHGEHDPGLPHQVLRQV 3 +$17206DQG 7(67(9, 5$(48,30(17ZLWKLQWUDRUDO; 5$,0$*(5( 5$ (48,30(17

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