1、April 2017 English price group 15No 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!%dTu“2654982www.din.deDI
2、N EN ISO 5366Anaesthetic and respiratory equipment Tracheostomy tubes and connectors (ISO 5366:2016);English version EN ISO 5366:2016,English translation of DIN EN ISO 5366:2017-04Ansthesie und Beatmungsgerte Tracheotomietuben und Verbindungsstcke (ISO 5366:2016);Englische Fassung EN ISO 5366:2016,E
3、nglische bersetzung von DIN EN ISO 5366:2017-04Matriel danesthsie et de ranimation respiratoire Raccords et tubes de trachostomie (ISO 5366:2016);Version anglaise EN ISO 5366:2016,Traduction anglaise de DIN EN ISO 5366:2017-04SupersedesDIN EN 12822:200912 andDIN EN ISO 53661:200907www.beuth.deDocume
4、nt comprises 34 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17 DIN EN ISO 5366:2017-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 5366:2016) has been prepared by Technical Committee
5、ISO/TC 121 “Anaesthetic and respiratory 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
6、und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-02 AA “Airways and related equipment”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 5356-1 DIN EN ISO 5356-1
7、 ISO 5361 DIN EN ISO 5361 ISO 80369-7 DIN EN ISO 80369-7 Amendments This standard differs from DIN EN 1282-2:2009-12 and DIN EN ISO 5366-1:2009-07 as follows: a) requirements for tracheostomy tubes for adults and children have been merged in this standard; b) the reference to ISO 18190 “Anaesthetic
8、and respiratory equipment General requirements for airways and related equipment” regarding fundamental requirements for tracheostomy tubes and connectors has been included; c) requirements for adaptors have been deleted; d) the 8,5 mm connector has been deleted and is thus not intended anymore; e)
9、requirements for cuffs have been revised and expanded; f) the requirement that tracheostomy tubes need to be easily detectable by X-ray has been included; g) the requirement for the kink resistance of tracheostomy tubes including test method has been included; h) an informative Annex A with a ration
10、ale on some requirements in the standard has been included; i) an informative Annex G with information on hazard identification for risk assessment has been included; j) requirements for information supplied by the manufacturer and marking have been revised; k) the informative Annex ZA showing the r
11、elationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC has been deleted; l) the standard has been editorially revised. DIN EN ISO 5366:2017-04 3 Previous editions DIN EN 1282-1: 1996-12 DIN EN 1282-2: 1997-10, 2005-09, 2009-12 DIN EN ISO 5366-1: 2004
12、-10, 2009-07 DIN EN ISO 5366:2017-04 4 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5361, Anaesthetic and respiratory equ
13、ipment Tracheal tubes and connectors DIN EN ISO 80369-7, Small bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5366 October 2016 ICS 11.040.
14、10 Supersedes 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 Verbind
15、ungsstcke(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
16、 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 language made by translation under t
17、he 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, Denmark, Estonia, Finland, Former Yugo
18、slav 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
19、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 5366:2016 EEuropean foreword .3Introduction 51 *Scope 62 Norm
20、ative references 63 Terms and definitions . 64 *General requirements for tracheostomy tubes and connectors . 85 Materials . 96 Design requirements for tracheostomy tubes and connectors . 96.1 General design requirements . 96.2 Size designation and dimensions 96.2.1 *Designated size . 96.2.2 Outside
21、dimension 106.2.3 Nominal length . 106.3 Design 106.3.1 Connector 106.3.2 Neck plate . 116.3.3 Inner tube . 116.3.4 *Cuffs 126.3.5 Inflating tubes for cuffs . 126.3.6 Cuff inflation indicator . 126.3.7 *Inflating tube 126.3.8 Patient end 136.3.9 Introducer . 136.3.10 *Radiopaque marker . 136.3.11 *K
22、ink resistance . 137 Requirements for tracheostomy tubes supplied sterile 137.1 Sterility assurance . 137.2 Packaging for tracheostomy tubes supplied sterile . 148 Information supplied by the manufacturer . 148.1 General 148.2 Marking of neck-plate . 148.3 Marking on the inflation indicator . 148.4
23、Marking of tracheostomy tube connectors 158.5 Additional labelling of unit packs 158.6 Labelling of inner tube unit packs 158.7 Labelling of tracheostomy tube inserts . 15Annex A (informative) Rationale .17Annex B (normative) Test method for the security of attachment of a fitted connector and neck-
24、plate to the tracheostomy tube .19Annex C (normative) Test method for determining the diameter of the cuff .21Annex D (normative) Test method for cuff herniation .22Annex E (normative) Test method for determining kink resistance .24Annex F (informative) Guidance on materials and design 26Annex G (in
25、formative) Hazard identification for risk assessment .27Bibliography .30Contents PageDIN EN ISO 5366:2017-04 EN ISO 5366:2016 (E) 2Foreword .4European foreword This document (EN ISO 5366:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboratio
26、n 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 latest by April 2017, and conflicting n
27、ational standards shall be withdrawn at the latest by April 2017. 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 all such patent rights. This document supers
28、edes EN ISO 5366-1:2009. 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, Finland, Former Yugoslav Republic
29、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 text of ISO 5366:2016 has been approved
30、 by CEN as EN ISO 5366:2016 without any modification. DIN EN ISO 5366:2017-04 EN ISO 5366:2016 (E) 3 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
31、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 and non-governmental, in liaison with ISO, also take part in the wo
32、rk. 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 described in the ISO/IEC Directives, Part 1. In particular the diff
33、erent 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 drawn to the possibility that some of the elements of this document ma
34、y 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 the ISO list of patent declarations received (see www.iso.org/paten
35、ts).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 assessment, as well as information about ISOs adherence to the World Trade O
36、rganization (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 and respiratory equipment, Subcommittee SC 2, Airways and related equipment.This first edition of ISO 5366
37、 cancels and replaces ISO 5366-1 and ISO 5366-3, which have been technically revised.DIN EN ISO 5366:2017-04 EN ISO 5366:2016 (E) 4 IntroductionThis International Standard provides the essential requirements for the design of cuffed and uncuffed tracheostomy tubes and connectors. These devices are i
38、ntended 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 aspiration and to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation for short or
39、 prolonged durations. Specialized tubes with walls reinforced with metal or nylon, tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases and the many other types of tracheostomy tubes devised for specialized applications are inclu
40、ded in this specification, as many specialized tracheostomy tubes are now commonly used, and all share similar essential requirements defined in this International Standard.The method of describing tube dimensions and configuration has been devised in order to assist clinicians in the selection of t
41、he 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. Because stoma and tracheal sizes are also important factors when selecting a tracheostomy tube, it is considered essential
42、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 dimensions and by the diameter of the cuff.A variety of cuff designs are available to meet particular clinical requirements.
43、This International Standard encompasses requirements for both paediatric and adult tracheostomy tubes. They share many common requirements that can be standardized and which are important for patient safety. An infant or child differs from an adult, not only in size, but also with regard to airway a
44、natomy and respiratory physiology; thus, airway equipment for paediatric patients differs from that for adults, both in size and in basic design. This International Standard does not require the connector to be permanently attached to the tube, as this can be impractical with infants and small child
45、ren. Other acceptable methods of connecting these components are available, and this International Standard makes provision for them. This International Standard does not limit the range of tube designs needed to match the variations in paediatric anatomy, lesions and space limitations encountered.K
46、ink 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 resist collapse and increased breathing resistance when bent or curved.Requirements for tracheostomy tubes that are common to o
47、ther 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.Throughout this International Standard, the following print types are used: requirements and definitions: roman type; test specificat
48、ions: 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; 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.DIN EN ISO 5366:2017-04 EN ISO 5366:2016 (E) 5 1 *ScopeThis International Standard specifies requirements for adult and paediatric trac
