DIN EN ISO 14408-2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408 2016) German version EN ISO 14408 2016《激光手术用气管导管 .pdf

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1、July 2016 English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!%XL=“2534126www.din.deDIN

2、 EN ISO 14408Tracheal tubes designed for laser surgery Requirements for marking and accompanying information (ISO 14408:2016);English version EN ISO 14408:2016,English translation of DIN EN ISO 14408:2016-07Trachealtuben fr die Laserchirurgie Anforderungen an die Kennzeichnung und die begleitenden I

3、nformationen (ISO 14408:2016);Englische Fassung EN ISO 14408:2016,Englische bersetzung von DIN EN ISO 14408:2016-07Tubes trachaux destins aux oprations laser Exigences relatives au marquage et aux informations daccompagnement (ISO 14408:2016);Version anglaise EN ISO 14408:2016,Traduction anglaise de

4、 DIN EN ISO 14408:2016-07SupersedesDIN EN ISO 14408:2009-08See start of applicationwww.beuth.deDocument comprises 18 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.16 DIN EN ISO 14408:2016-07 2 A comma is used as the decima

5、l marker. Start of application The start of application of this standard is 2016-07-01. For DIN EN ISO 14408:2009-08 there is a transition period ending on 31 March 2019. National foreword This document (EN ISO 14408:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respirat

6、ory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Commi

7、ttee Rescue Services and Hospital), Working Committee NA 53-03-02 AA Medizinprodukte fr das Atemwegssystem. This standard contains specifications giving detail to the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Sta

8、ndards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 5361 DIN EN ISO 5361 ISO 7000 DIN ISO 7000 ISO 11990-1 DIN EN ISO 11990-1 ISO 11990-2 DIN EN ISO 11990-2 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 14408:2009-08 as follows: a) the r

9、equirements for marking, labelling and the information to be supplied by the manufacturer have been revised; it has been specified that packs are to be provided with an indication on the presence of natural rubber (latex), if present in the device; b) the requirements for the graphical representatio

10、n of the test results have been revised with reference to the ISO 11990 standards series; c) Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been revised; d) the standard has been editorially revised. Previous editions DIN EN ISO 14

11、408: 2005-09, 2009-08 DIN EN ISO 14408:2016-07 3 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors DIN EN ISO 11990-1, Lasers and laser-related equipment

12、Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft DIN EN ISO 11990-2, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, la

13、belling and information to be supplied Part 1: General requirements DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 14408:2016-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14408 March 2016 ICS 11.040.10 Supersedes E

14、N ISO 14408:2009English Version Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information(ISO 14408:2016) Tubes trachaux destins aux oprations laser - Exigences relatives au marquage et aux informations daccompagnement (ISO 14408:2016) Trachealtuben fr die Las

15、erchirurgie - Anforderungen an die Kennzeichnung und die begleitenden Informationen (ISO 14408:2016) This European Standard was approved by CEN on 30 January 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standa

16、rd 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English,

17、 French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulg

18、aria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tu

19、rkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

20、 Ref. No. EN ISO 14408:2016 EForeword . 6Introduction 71 Scope . 82 Normative references 83 Terms and definitions . 84 Marking and labelling . 94.1 Use of symbols . 94.2 Marking . 94.3 Labelling of packs 104.4 Labelling of shelf or multi-unit containers 105 Information to be supplied by the manufact

21、urer 115.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments . 115.2 Indications for use 115.3 Warnings and precautions about the use of the tube . 115.4 Graph showing test results for laser resistance 11Bibliography .14Contents PageAnnex ZA (informat

22、ive) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4 European foreword .iv3DIN EN ISO 14408:2016-07 EN ISO 14408:2016 (E) 2 European foreword This document (EN ISO 14408:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and

23、respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the

24、latest by September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or a

25、ll such patent rights. This document supersedes EN ISO 14408:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see infor

26、mative 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 Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia

27、, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The tex

28、t of ISO 14408:2016 has been approved by CEN as EN ISO 14408:2016 without any modification. DIN EN ISO 14408:2016-07 EN ISO 14408:2016 (E)3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prep

29、ared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive an

30、d has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE 1 Where a referenc

31、e from a clause of this European Standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lo

32、west possible level“, “minimized“ or “removed“, according to the wording of the corresponding essential requirement. NOTE 2 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standa

33、rd and Directive 93/42/EEC Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4.3 g) 4.4 g) 8.7 Partly covered. Marked sterile if appropriate. 5.2.2 5.5.4, 5.9, 5.5.1 9.1 Partly covered, limited to information relating to us

34、e with laser surgery equipment. 4.2.2 b) 4.2.3 4.3 d), e), j) 4.4 d), e) 9.2 (first and second indent) Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the ID/OD of the tracheal tube, optional positioning ma

35、rks, marking for the OD of the cuff. 4.2.3 10.2 Partly addressed with optional marks to aid in intubation positioning. 4 13.1 Partly covered by mandating limited marking and labelling and instructions on the tube, unit and packing labels, and instructions for use. 4.1 13.2 Partly covered. Symbols ar

36、e mandated to conform to ISO 7000 or - EN ISO 15223-1 4.2.2 a) 4.3 b) 13.3 a) Name and or trademark of manufacturer or supplier mandated on the device and on individual pack. DIN EN ISO 14408:2016-07 EN ISO 14408:2016 (E) 4 4.4 b) Authorized representative mandated 4.3 a) 4.4 a) 13.3 b) 4.3 g) 4.4 g

37、) 13.3 c) Only identifies that the device is sterile (if applicable). 4.3 f) 4.4 f) 13.3 d) Very limited only to the choice of either a batch number or serial number or year of manufacture on the individual pack; batch number on the shelf/multi-pack. 4.3 k) 4.4 i) 13.3 e) 4.3 h) 4.4 h) 13.3 f) 4.2.2

38、 d) 4.3 j) 4.4 k) 5.1.1 13.3 i) Limited to information regarding laser resistance and related special set-up instructions 4.3 l) 4.4 l) 5.4 13.3 i) Limited to information charts regarding laser resistance. 4.3 l) 4.4 l) 5.4 13.3 j) Limited to information charts regarding laser resistance. 5.3 13.3 k

39、) 4 13.6 a) Mandated markings, labelling and instructions, limited to those listed above. 5.4 13.6 b) Limited to information charts regarding laser resistance. 5.1.2 13.6 h), first sentence Partly covered to mandated instructions for cleaning and disinfection or sterilization. 5.1.1 13.6 i) Limited

40、to details for preparation for use related to laser resistance. 5.3 13.4 l) Party covered to precautions relating to contact with lasers. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this document. DIN EN ISO 14408:2016-07 EN ISO 1

41、4408:2016 (E)5 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject

42、 for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC)

43、on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be note

44、d. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying

45、any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of

46、 users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplem

47、entary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related Equipment.This third edition cancels and replaces the second edition (ISO 14408:2005), which has been technically revised.Major changes include a

48、n update on the normative references to ISO 11990-1, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1 Tracheal tube shaft and ISO 11990-2, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs.The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period foll