EN ISO 14408-2016 en Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information《激光手术用气管-标志和提供信息的要求(ISO 14408 2016)》.pdf

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1、BSI Standards PublicationBS EN ISO 14408:2016Tracheal tubes designed forlaser surgery Requirementsfor marking and accompanyinginformationBS EN ISO 14408:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 14408:2016. It supersedes BS EN ISO 14408:2009 which

2、 iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Airways and related equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provision

3、s of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82785 3 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published

4、under the authority of the Standards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14408 March 2016 ICS 11.040.10 Supersedes EN ISO 14408:2009English Version Tracheal t

5、ubes 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 Laserchirurgie - Anforderungen an die Kennze

6、ichnung 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 Standard the status of a national standard with

7、out 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, French, German). A version in any other

8、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, Bulgaria, Croatia, Cyprus, Czech Republic, De

9、nmark, 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, Turkey and United Kingdom. EUROPEAN COMMITT

10、EE 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. Ref. No. EN ISO 14408:2016 EBS EN ISO 14

11、408:2016EN ISO 14408:2016 (E) 3 European foreword This document (EN ISO 14408:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is he

12、ld 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 latest by September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. Attention is drawn to the possibility

13、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 all such patent rights. This document supersedes EN ISO 14408:2009. This document has been prepared under a mandate given to CEN by the European Com

14、mission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organization

15、s of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

16、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 14408:2016 has been approved by CEN as EN ISO 14408:2016 without any modification. BS EN ISO 14408:2016EN ISO 14408:2016 (E) 4 Annex ZA (i

17、nformative) 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 to provide a means of conforming to Essential Requ

18、irements of Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the

19、limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE 1 Where a reference 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

20、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 lowest possible level“, “minimized“ or “removed“, according to the wording of the corresponding essential requirement. NOTE 2 When an Essential Requireme

21、nt 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 Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/not

22、es 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 use 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 injur

23、y in connection with their physical features by specifying sizing and marking conventions for the ID/OD of the tracheal tube, optional positioning marks, 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 mandati

24、ng limited marking and labelling and instructions on the tube, unit and packing labels, and instructions for use. 4.1 13.2 Partly covered. Symbols are 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

25、and on individual pack. BS EN ISO 14408:2016EN ISO 14408:2016 (E) 5 4.4 b) Authorized representative mandated 4.3 a) 4.4 a) 13.3 b) 4.3 g) 4.4 g) 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 seri

26、al 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 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

27、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) 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 resistan

28、ce. 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 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 req

29、uirements and other EU Directives may be applicable to the products falling within the scope of this document. BS EN ISO 14408:2016ISO 14408:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Marking and labelling . 24.1 Use of symbols . 24.2 Marking . 24

30、.3 Labelling of packs . 34.4 Labelling of shelf or multi-unit containers . 35 Information to be supplied by the manufacturer . 45.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments 45.2 Indications for use . 45.3 Warnings and precautions about the us

31、e of the tube 45.4 Graph showing test results for laser resistance . 4Bibliography 7 ISO 2016 All rights reserved iiiContents PageBS EN ISO 14408:2016ISO 14408:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member b

32、odies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental a

33、nd non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are d

34、escribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is dra

35、wn 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 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

36、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 users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessme

37、nt, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and r

38、elated Equipment.This third edition cancels and replaces the second edition (ISO 14408:2005), which has been technically revised.Major changes include an update on the normative references to ISO 11990-1, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1 T

39、racheal 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 following p

40、ublication of a new, amended, or revised ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationa

41、lly not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.iv ISO 2016 All rights reservedBS EN ISO 14408:2016ISO 14408:2016(E)IntroductionThis International Standard is intended

42、 to provide requirements for marking, labelling, and information supplied for tracheal tubes which are designed for resistance to ignition by a laser and which have been tested for laser resistance in accordance with ISO 11990-1 and ISO 11990-2 including a standard format for reporting results obtai

43、ned when tested in accordance with ISO 11990-1 and ISO 11990-2. It is intended that, by limiting the requirements to disclosure of information determined in accordance with standard test methods, the manufacturer will be allowed maximum use of alternatives in design and materials. ISO 2016 All right

44、s reserved vBS EN ISO 14408:2016BS EN ISO 14408:2016Tracheal tubes designed for laser surgery Requirements for marking and accompanying information1 ScopeThis International Standard specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tube

45、s and related materials designed to resist ignition by a laser2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the l

46、atest edition of the referenced document (including any amendments) applies.ISO 70001), Graphical symbols for use on equipment Registered symbolsISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 1

47、1990-1, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaftISO 11990-2, Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs3 Terms and definitionsFor the purposes of this doc

48、ument, the following terms and definitions apply.3.1tracheal tubetube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the tracheaSOURCE: ISO 4135:20013.2cuffinflatable balloon permanently attached around the tracheal tube near the patient end to pro

49、vide an effective seal between the tube and the tracheaSOURCE: ISO 4135:2001, modified3.3laser-resistant tracheal tubetracheal tube specifically designed by the manufacturer for use during laser surgery of the airwayNote 1 to entry: This includes devices sold preassembled or in kit form.1) The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more information, consulthttp:/www.iso.org/iso/publications_and_e-products/databases.htm?= .INTERNATIONAL STANDARD ISO 14408:2016(E) ISO 2016 All rights reserv