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    BS EN 60601-2-23-2000 Medical electrical equipment - Particular requirements for the safety including essential performance of transcutaneous partial pressure monitoring equipment《.pdf

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    BS EN 60601-2-23-2000 Medical electrical equipment - Particular requirements for the safety including essential performance of transcutaneous partial pressure monitoring equipment《.pdf

    1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 60601-2-23:2000 IEC

    2、 60601-2-23:1999 The European Standard EN 60601-2-23:2000 has the status of a British Standard ICS 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Medical electrical equipment Part 2-23: Particular requirements for the safety, including essential performance, of tran

    3、scutaneous partial pressure monitoring 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 June 2000 BSI 06-2000 ISBN 0 580 34057 0 BS EN 6060

    4、1-2-23:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the offical English language version of EN 60601-2-23:2000. It is identical with IEC 60601-2-23:1999. It supersedes BS EN 60601-2-23:1995 and BS EN 60601-3-1:1997 which are withdrawn. Th

    5、e UK participation in its preparation was entrusted to Technical Committee CH/96, Monitoring equipment, 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

    6、 keep the UK interests informed; monitor related international and European 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

    7、number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For 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 inclu

    8、de an annex which lists normative references to international publications 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 Standard

    9、s Correspondence Index”, or by using the “Find” facility of the BSI Standards 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

    10、does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, the EN foreword page, pages 3 to 35, the annex ZA and ZB pages and a back cover. The BSI copyright notice displayed in this document indicates

    11、when the document was last issued.EN 60601-2-23:2000%6, 3527(785(6 6(&(66,9(7(03(5$785(6 $127+(56$)(7+$=$56 (FHVVLYHWHPSHUDWXUHV 2YHUIORZVSLOODJHOHDNDJHKXPLGLWLQJUHVVRIOLTXLGVFOHDQLQJVWHULOLDWLRQ GLVLQIHFWLRQDQGFRPSDWLELOLW ,QWHUUXSWLRQRIWKHSRZHUVXSSO 6(&7,21(,*+7$&85$&2)23(5$7,1*$7$13527(&7,21 $*$,

    12、167+$=$5286287387 3URWHFWLRQDJDLQVWKDDUGRXVRXWSXW 6(&7,211,1($%1250$/23(5$7,21$1)$8/7&21,7,216 (19,5210(17$/7(676 $EQRUPDORSHUDWLRQDQGIDXOWFRQGLWLRQV 6(&7,217(1&216758&7,21$/5(48,5(0(176 &RPSRQHQWVDQGJHQHUDODVVHPEO 0 $,163$576FRPSRQHQWVDQGODRXW Page 3 EN 60601-2-23:2000%6, )LJXUH7 5$168&(5FDEOHVWUDL

    13、QUHOLHIWHVW )LJXUH)RDPEORFNWHVW )LJXUHD/LQHDULWDQGKVWHUHVLVWHVWVHWXS*DVPLFKDPEHUDVVHPEOHG )LJXUHE/LQHDULWDQGKVWHUHVLVWHVWVHWXS*DVPLFKDPEHU PDQXIDFWXULQJGLPHQVLRQV )LJXUHF/LQHDULWDQGKVWHUHVLVWHVWVHWXS*DVPLFKDPEHUGLPHQVLRQV RIKRVHFRQQHFWRU )LJXUH(0&WHVWVHWXSIRUFRQGXFWHGDQGUDGLDWHGHPLVVLRQ DQGUDGLDWHGL

    14、PPXQLWWHVW $SSHQGL/QRUPDWLYH 5HIHUHQFHV3XEOLFDWLRQVPHQWLRQHGLQWKLVVWDQGDUG $QQH$LQIRUPDWLYH *HQHUDOJXLGDQFHDQGUDWLRQDOH $QQH =$ QRUPDWLYH 1RUPDWLYH UHIHUHQFHV WR LQWHUQDWLRQDO SXEOLFDWLRQV ZLWK WKHLU FRUUHVSRQGLQJ(XURSHDQSXEOLFDWLQV $QQH=%LQIRUPDWLYH2WKHULQWHUQDWLRQDOSXEOLFDWLRQVPHQWLRQHGLQWKLVVWDQG

    15、DUGZLWKWKH UHIHUHQFHVRIWKHUHOHYDQW(XURSHDQSXEOLFDWLRQV Page 4 EN 60601-2-23:2000%6, 0(,&$/(/(&75,&$/(48,30(17 3DUW3DUWLFXODUUHTXLUHPHQWVIRUWKHVDIHW LQFOXGLQJHVVHQWLDOSHUIRUPDQFHRIWUDQVFXWDQHRXVSDUWLDO SUHVVXUHPRQLWRULQJHTXLSPHQW 6(&7,2121(*(1(5$/ 7KHFODXVHVDQGVXEFODXVHVRIWKH*HQHUDO6WDQGDUGDSSOHFHSWD

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    18、5HSODFHPHQW 7KHREMHFWRIWKLV3DUWLFXODU6WDQGDUGLVWRHVWDEOLVKSDUWLFXODUUHTXLUHPHQWVIRUWKHVDIHW LQFOXGLQJ HVVHQWLDO SHUIRUPDQFH RI 75$16&87$1(286 3$57,$/ 35(6685( 021,725,1* (48,30(17DVGHILQHGLQ 3DUWLFXODUVWDQGDUGV $GGLWLRQ 7KLV3DUWLFXODU6WDQGDUGDPHQGVDQGVXSSOHPHQWVDVHWRI,(&SXEOLFDWLRQVFRQVLVWLQJRI ,(&

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