BS EN ISO 5366-2016 Anaesthetic and respiratory equipment Tracheostomy tubes and connectors《麻醉和呼吸设备 气管导管和连接器》.pdf

1、BS EN ISO 5366:2016Anaesthetic and respiratoryequipment Tracheostomytubes and connectors (ISO5366:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 5366:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5366:2

2、016. It supersedes BS EN ISO 5366-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Airways and related equipment.A list of organizations represented on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

3、 purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 80997 2 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal o

4、bligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 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 5366 October 2016 ICS 11.040.10 Sup

5、ersedes EN ISO 5366-1:2009English Version Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016) Matriel danesthsie et de ranimation respiratoire - Raccords et tubes de trachostomie (ISO 5366:2016) Ansthesie- und Beatmungsgerte - Tracheotomietuben und Verbindungsst

6、cke (ISO 5366:2016) This European Standard was approved by CEN on 20 August 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 without any alteration. Up-to-date lists and

7、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 language made by translation under the re

8、sponsibility 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, Denmark, Estonia, Finland, Former Yugoslav

9、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 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NO

10、RMALISATION 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 5366:2016 EContents PageEuropean foreword . 3 BS EN ISO 5366:2016E

11、N ISO 5366:2016 (E)3 European foreword This document (EN ISO 5366:2016) 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 held by BSI. Th

12、is 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 April 2017, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the

13、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 5366-1:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the f

14、ollowing 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, Netherland

15、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5366:2016 has been approved by CEN as EN ISO 5366:2016 without any modification. BS EN ISO 5366:2016EN ISO 5366:2016 (E)BS EN ISO 5366:2016 ISO 2016

16、Anaesthetic and respiratory equipment Tracheostomy tubes and connectorsMatriel danesthsie et de ranimation respiratoire Raccords et tubes de trachostomieINTERNATIONAL STANDARDISO5366First edition2016-10-01Reference numberISO 5366:2016(E)BS EN ISO 5366:2016ISO 5366:2016(E)ii ISO 2016 All rights reser

17、vedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intra

18、net, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.i

19、so.orgBS EN ISO 5366:2016ISO 5366:2016(E)Foreword ivIntroduction v1 *Scope 12 Normative references 13 Terms and definitions . 14 *General requirements for tracheostomy tubes and connectors . 35 Materials . 46 Design requirements for tracheostomy tubes and connectors . 46.1 General design requirement

20、s . 46.2 Size designation and dimensions 46.2.1 *Designated size . 46.2.2 Outside dimension . 56.2.3 Nominal length 56.3 Design . 56.3.1 Connector . 56.3.2 Neck plate 66.3.3 Inner tube 66.3.4 *Cuffs . 76.3.5 Inflating tubes for cuffs 76.3.6 Cuff inflation indicator 76.3.7 *Inflating tube . 76.3.8 Pa

21、tient end . 86.3.9 Introducer 86.3.10 *Radiopaque marker 86.3.11 *Kink resistance 87 Requirements for tracheostomy tubes supplied sterile . 87.1 Sterility assurance 87.2 Packaging for tracheostomy tubes supplied sterile 98 Information supplied by the manufacturer . 98.1 General . 98.2 Marking of nec

22、k-plate 98.3 Marking on the inflation indicator 98.4 Marking of tracheostomy tube connectors 108.5 Additional labelling of unit packs 108.6 Labelling of inner tube unit packs 108.7 Labelling of tracheostomy tube inserts . 10Annex A (informative) Rationale .12Annex B (normative) Test method for the s

23、ecurity of attachment of a fitted connector and neck-plate to the tracheostomy tube .14Annex C (normative) Test method for determining the diameter of the cuff .16Annex D (normative) Test method for cuff herniation .17Annex E (normative) Test method for determining kink resistance .19Annex F (inform

24、ative) Guidance on materials and design 21Annex G (informative) Hazard identification for risk assessment .22Bibliography .25 ISO 2016 All rights reserved iiiContents PageBS EN ISO 5366:2016ISO 5366:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of

25、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 for which a technical committee has been established has the right to be represented on that committee. Inte

26、rnational organizations, governmental and 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 int

27、ended 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 noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see ww

28、w.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 any or all such patent rights. Details of any patent rights identified during the development of the document

29、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 users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expre

30、ssions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 121, Anaesthetic a

31、nd respiratory equipment, Subcommittee SC 2, Airways and related equipment.This first edition of ISO 5366 cancels and replaces ISO 5366-1 and ISO 5366-3, which have been technically revised.iv ISO 2016 All rights reservedBS EN ISO 5366:2016ISO 5366:2016(E)IntroductionThis International Standard prov

32、ides the essential requirements for the design of cuffed and uncuffed tracheostomy tubes and connectors. These devices are intended to be inserted through a stoma in the trachea to convey gases and vapours to and from the trachea. Cuffed devices are designed to seal and protect the trachea from aspi

33、ration and to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation for short or prolonged durations. Specialized tubes with walls reinforced with metal or nylon, tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or de

34、livery of drugs or other gases and the many other types of tracheostomy tubes devised for specialized applications are included in this specification, as many specialized tracheostomy tubes are now commonly used, and all share similar essential requirements defined in this International Standard.The

35、 method of describing tube dimensions and configuration has been devised in order to assist clinicians in the selection of the most suitable tube for a particular patients anatomy. Size is designated by the internal dimension, which is important because of its relationship to resistance to gas flow.

36、 Because stoma and tracheal sizes are also important factors when selecting a tracheostomy tube, it is considered essential that the outside dimension for each size of tube is also made known to the user.Cuffed tracheostomy tubes can be characterized by a combination of the tube inside and outside d

37、imensions and by the diameter of the cuff.A variety of cuff designs are available to meet particular clinical requirements. This International Standard encompasses requirements for both paediatric and adult tracheostomy tubes. They share many common requirements that can be standardized and which ar

38、e important for patient safety. An infant or child differs from an adult, not only in size, but also with regard to airway anatomy and respiratory physiology; thus, airway equipment for paediatric patients differs from that for adults, both in size and in basic design. This International Standard do

39、es not require the connector to be permanently attached to the tube, as this can be impractical with infants and small children. Other acceptable methods of connecting these components are available, and this International Standard makes provision for them. This International Standard does not limit

40、 the range of tube designs needed to match the variations in paediatric anatomy, lesions and space limitations encountered.Kink resistance requirements with associated test methods have also been added to this International Standard to measure the ability of the shaft of the tracheostomy tube to res

41、ist collapse and increased breathing resistance when bent or curved.Requirements for tracheostomy tubes that are common to other airway and related devices have been removed from this International Standard as these are now included in ISO 18190, which is cross referenced where appropriate.Throughou

42、t this International Standard, the following print types are used: requirements and definitions: roman type; test specifications: italic type; informative material appearing outside of tables, such as notes, examples and references: smaller type. The Normative text of tables is also in smaller type;

43、 terms defined in clause 3: small caps.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A. ISO 2016 All rights reserved vBS EN ISO 5366:2016BS EN ISO 5366:2016Anaesthetic an

44、d respiratory equipment Tracheostomy tubes and connectors1 *ScopeThis International Standard specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.

45、This International Standard is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, taper

46、ing tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addre

47、ssed by appropriate clinical management and is outside the scope of this International Standard.NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its

48、application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 4135, Anaesthetic and respiratory equipment VocabularyISO 5356-1, Anaesthetic and respiratory equipment Conical connectors P

49、art 1: Cones and socketsISO 18190:2016, Anaesthetic and respiratory equipment General requirements for airways and related equipmentISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applicationsASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Re