EN ISO 14408-2009 3125 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information《激光手术用气管导管 标记和伴随信息的要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14408:2009Tracheal tubes designed forlaser surgery Requirementsfor marking and accompanyinginformation (ISO 14408:2005)Copyright European Committee for Standardization

2、Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 14408:2009 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO14408:2009. It is identical to ISO 14408:2005. It supersedes BS EN IS

3、O14408:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purpor

4、t to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 65554 8ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards

5、 Policy and Strategy Committee on 30 September 2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EU

6、ROPENNEEUROPISCHE NORMEN ISO 14408April 2009ICS 11.040.10 Supersedes EN ISO 14408:2005 English VersionTracheal tubes designed for laser surgery - Requirements formarking and accompanying information (ISO 14408:2005)Tubes trachaux destins aux oprations laser - Exigencesrelatives au marquage et aux in

7、formationsdaccompagnement (ISO 14408:2005)Trachealtuben fr die Laserchirurgie - Anforderungen andie Kennzeichnung und die begleitenden Informationen(ISO 14408:2005)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations wh

8、ich stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Sta

9、ndard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national stan

10、dards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United King

11、dom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14408:2009: ECopyrigh

12、t European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 14408:2009EN ISO 14408:2009 (E) 3 Foreword The text of ISO 14408:2005 has been prepared by Technical Committee ISO/TC 121 “Anaes

13、thetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14408:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the stat

14、us of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subje

15、ct of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14408:2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and suppor

16、ts essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European

17、 Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kin

18、gdom. Endorsement notice The text of ISO 14408:2005 has been approved by CEN as a EN ISO 14408:2009 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS E

19、N ISO 14408:2009EN ISO 14408:2009 (E) 4 Annex ZA (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association

20、 to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, c

21、ompliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Stand

22、ard and EU Directives Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.1 13.2 4.2 13.1 4.2.8 13.3 m)4.3 13.34.3 a) 13.3 b), 13.4 4.3 b) 13.3 a) 4.3 c) 13.3 d) 4.3 d) 13.3 b) 4.3 e) 13.3 b) 4.3 f) 13.3 d) 4.3 g) 8.7, 13.3 c) 4.3 h) 13.3

23、 f) 4.3 i) 13.3 b) 4.3 j) 13.3 i) 4.3 k) 13.3 e) 4.3 l) 13.3 j) 4.4 a) 13.3 b) 4.4 b) 13.3 b) 4.4 c) 13.3 d) 4.4 d) 13.3 b) 4.4 e) 13.3 b) 4.4 f) 13.3 d) 4.4 g) 8.7, 13.3 c) 4.4 h) 13.3 f) 4.4 i) 13.3 e) 4.4 k) 13.3 i) 4.4 l) 1.3, 13.6 c) Copyright European Committee for Standardization Provided by

24、IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 14408:2009EN ISO 14408:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.1.1 13.6 d) 5.1.2 h) 5.2 13.1, 13

25、.6 c) 5.3 13.1, 13.6 b) 5.4 13.1, 13.3 j) 1 through 5 13.1 - 13.3 (a): This relevant Essential Requirement is not fully addressed in this Standard- 13.3 (f) This relevant Essential Requirement is not fully addressed in this Standard- 13.6 (h) (2nd paragraph) This relevant Essential Requirement is no

26、t fully addressed in this Standard- 13.6 (h) (3rd paragraph) This relevant Essential Requirement is not fully addressed in this Standard- 13.6 (q) This relevant Essential Requirement is not addressed in this StandardWARNING: Other requirements and other EU Directives may be applicable to the product

27、(s) falling within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 14408:2009, 62 nullnull nullnullnull null ( null , 62 nullnullnull $ OO U

28、 LJK WV U H V H U Y H G LLL) R U H Z R U G, 62 nullW KH , Q W H U Q D W L RQD O 2 U J D Q L D W L RQ I R U 6 W D Q GDU G L D W L RQnull L V D Z R U O G Z L G HIH G H U D W L RQ R I Q D W L RQD O VWD Q GDU G V E R G LHVnull , 62 P H P E H U E R G LHV nullnull 7 KH Z R U NRI S U H S D U L Q J , Q W H

29、U Q D W L RQD O 6 W D Q GDU G V L V QRU P D OO FDUULHG R XW W K U R X JK , 62W H F K Q L FDO F RPP L WWHHV null ( DFK P H P E H U E R G L Q W H U H VWH G L Q D VXE MHF W I R U Z KLF K D W H F K Q L FDO F RPP L WWHH K D V E HHQH VWDEO L V KHG K D VWKH U LJK WWR E H U H S U H V H Q W H G RQ W K D W F

30、RPP L WWHHnull , Q W H U Q D W L RQD ORU J D Q L D W L RQV null J R Y H U QPH Q W D O D Q GQRQnull J R Y H U QPH Q W D O null L QOL D L V RQ Z L W K , 62null D O V R W D N H S D UW L Q W KH Z R U N null , 62 F ROODER U D W H V F ORV H O ZL W K W KH, Q W H U Q D W L RQD O ( O H F WUR W H F K Q L FDO

31、& RPP L VVL RQ null, ( & null RQ D OO P D WWH UV R IHO H F WUR W H F K Q L FDO VWD Q GDU G L D W L RQnull , Q W H U Q D W L RQD O 6 W D Q GDU G V D U H G U D I W H G L Q DFF R U GDQ F H Z L W K W KH UXO H V JLY H Q L Q W KH , 62null , ( & L U H F W L Y H V null 3 D UW nullnull7 KH P D L Q W D V NRI

32、W H F K Q L FDO F RPP L WWHHV L VWRSU H S D U H , Q W H U Q D W L RQD O 6 W D Q GDU G V null U D I W , Q W H U Q D W L RQD O 6 W D Q GDU G VDGRSW H GE W KH W H F K Q L FDO F RPP L WWHHV D U H F L U F X O D W H G W R W KH P H P E H U E R G LHV I R U Y R W L Q J null 3 X E O L FDW L RQ D V D Q, Q W H

33、U Q D W L RQD O 6 W D Q GDU G U H TXL U H V D SSU R Y D O E D W O H D VW null R I W KH P H P E H U E R G LHV FDVWL Q J D Y R W H null $ WWH Q W L RQ L V G U D Z Q W R W KH SRVVL E L O L W W K D WVRPH R I W KH H O H P H Q WV R I W KLV G R F X P H Q W P D E H W KH VXE MHF W R I S D W H Q WU LJK WVnull

34、 , 62 V K D OO QRW E HKH O G U H V SRQV L E O HIR U L G H Q W LI L Q J D Q R U D OO VXF K S D W H Q WULJK WVnull , 62 null null Z D V S U H S D U H GE 7 H F K Q L FDO & RPP L WWHH , 62null 7 & nullnullnullnull $ QDHVWKHW LF DQG U H V SLU D W R U HTX LSPHQ W null 6 X EFRPP L WWHH 6 & nullnull 7 U DFK

35、HDO WXEHV DQG R W KHU HTX LSPHQ W null 7 KLVVH F RQG H G L W L RQ FDQ F H O V D Q G U H SODFH VWKH ILUVW H G L W L RQ null, 62 null null null nullnull & O D XVH V D Q G D Q G ) LJXUH null R IZ KLF KKD Y H E HHQ W H F K Q L FDOO U H Y L V H G null) R UWKH S XUSRV H V R I W KLV , Q W H U Q D W L RQD O

36、 6 W D Q GDU G null W KH & ( 1 D QQH U HJD U G L Q JIX O ILOPH Q W R I ( XURSH D Q & R X Q F L O L U H F W L Y H V K D V E HHQ U H PRY H G null Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license

37、 from IHS-,-,-BS EN ISO 14408:2009, 62 nullnull nullnullnull null ( nullL Y , 62 nullnullnull $ OO U LJK WV U H V H U Y H G, Q WUR G X F W L RQ7 KLV , Q W H U Q D W L RQD O 6 W D Q GDU G L V L Q W H Q G H G W RSU R Y L G H U H TXL U H P H Q WV I R U P D U N L Q J null O DEH OOL Q J D Q G L Q I R U P

38、 D W L RQ VXSSO LHGI R UWU DFKHD O WXE H V Z KLF K D U H G H V LJQ H G I R UUH V L VWD Q F H W R LJQ L W L RQ E D O D V H U D Q G Z KLF KKD Y H E HHQ W H VWH G I R U O D V H UU H V L VWD Q F HLQ DFF R U GDQ F H Z L W K , 62 nullnullnull L Q F O X G L Q J D VWD Q GDU G I R U P D W I R UUH SRUWL Q J U

39、 H VXO WV R E W D L Q H G Z KHQW H VWH G L Q DFF R U GDQ F H Z L W K , 62 nullnullnullnull , W L V L Q W H Q G H G W K D W null E O L P L W L Q J W KH U H TXL U H P H Q WV W R G L V F ORVXU H R IL Q I R U P D W L RQ G H W H U P L Q H G L Q DFF R U GDQ F H Z L W K VWD Q GDU G W H VW P H W K R G V nul

40、l W KH P D Q X I DFWXUH U Z L OO E H D OORZ H G P D L P X PXVH R I D O W H U Q D W L Y H V L Q G H V LJQ D Q G P D W H U L D O V nullCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,

41、-,-BS EN ISO 14408:2009,17 ( 5 1 $ 7 , 2 1 $ / 67$ 1 $ 5 , 62 nullnull nullnullnull null ( null , 62 nullnullnull $ OO U LJK WV U H V H U Y H G null7 U DFKHD O WXE H V G H V LJQ H G I R U O D V H UVXUJHU 5 H TXL U H P H Q WVI R U P D U N L Q J D Q GDFFRPS D Q L Q JLQ I R U P D W L RQnull 6 F RSH7 KLV , Q W H U Q D W L RQD O 6 W D Q GDU G V S H F LILHV P D U N L Q J null O DEH OOL Q J D Q G L Q I R U P D W L RQ W R E H VXSSO LHGE W KH P D Q X I DFWX