EN ISO 5366:2016
(Main)Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
ISO 5366:2016 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.
ISO 5366:2016 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, tapering 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 addressed by appropriate clinical management and is outside the scope of this International Standard.
NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.
Anästhesie- und Beatmungsgeräte - Tracheotomietuben und Verbindungsstücke (ISO 5366:2016)
Diese Internationale Norm legt Anforderungen an TRACHEOTOMIETUBEN für Erwachsene und an pädiatrische TRACHEOTOMIETUBEN fest. Derartige Tuben sind primär für Patienten bestimmt, die eine Anästhesie, künstliche Beatmung oder sonstige Atemunterstützung benötigen.
Die vorliegende Internationale Norm ist auch auf Spezial-TRACHEOTOMIETUBEN mit gemeinsamen Merkmalen anwendbar, z. B. Tuben ohne Verbindungsstück am MASCHINENENDE für spontan atmende Patienten und Tuben mit verstärkten Wänden oder Tuben aus Metall oder mit Schultern, konische Tuben, Tuben mit Möglichkeiten zum Absaugen, zum Überwachen oder zur Zufuhr von Medikamenten oder sonstigen Gasen.
Es ist bekannt, dass TRACHEOTOMIETUBEN (zum Beispiel bei Verwendung mit elektrochirurgischen Geräten oder Lasern und brennbaren Anästhesiemitteln in einer mit Oxidationsmittel angereicherten Atmosphäre) sich entzünden können; dieser Gefährdung wird durch das angemessene klinische Management entgegengewirkt, das außerhalb des Anwendungsbereichs dieser Internationalen Norm liegt.
ANMERKUNG ISO/TR 11991 enthält eine Anleitung zu Vermeidung von Feuer in den Luftwegen.
Matériel d'anesthésie et de réanimation respiratoire - Raccords et tubes de trachéostomie (ISO 5366:2016)
ISO 5366:2016 spécifie les exigences relatives aux raccords et tubes de trachéostomie pour les adultes et les applications pédiatriques. L'usage de ces tubes est essentiellement réservé aux patients dont l'état nécessite une anesthésie, une respiration artificielle ou toute autre aide respiratoire.
Le domaine d'application de la présente Norme internationale couvre également les tubes de trachéostomie spéciaux qui partagent des attributs communs, par exemple les tubes sans raccord à l'extrémité «appareil» conçus pour les patients qui respirent de façon naturelle, les tubes à paroi renforcée, les tubes métalliques ou les tubes à épaulement, les tubes coniques, les tubes avec dispositifs pour aspiration ou surveillance ou administration de médicaments ou autres gaz.
Si, par exemple, des agents d'anesthésie inflammables sont utilisés avec des appareils d'électrochirurgie ou des lasers dans des atmosphères enrichies en oxydant, l'inflammabilité des tubes de trachéostomie constitue un danger bien connu, qui est géré par des pratiques cliniques appropriées, mais qui ne relève pas du domaine d'application de la présente Norme internationale.
NOTE L'ISO/TR 11991 donne des préconisations concernant la façon d'éviter les incendies de canule.
Anestezijska in dihalna oprema - Traheostomske cevke in priključki (ISO 5366:2016)
Ta mednarodni standard določa zahteve za traheostomske cevke in priključke za odrasle in otroke. Takšne cevke so zasnovane predvsem za bolnike, ki potrebujejo anestezijo, umetno ventilacijo ali drugo dihalno podporo.
Ta mednarodni standard se uporablja tudi za specializirane traheostomske cevke s skupnimi lastnostmi, na primer cevke brez priključka na aparatu, namenjene za bolnike, ki dihajo spontano, in cevke z ojačanimi stenami ali cevke, izdelane iz kovine, ali cevke z izboklinami, konusne cevke, cevke s sredstvi za sesanje, nadzorovanje ali dovajanje zdravil ali drugih plinov.
Vnetljivost traheostomskih cevk je dobro poznana nevarnost (npr. pri uporabi elektrokirurških enot ali laserjev z vnetljivimi anestetiki v okolju, obogatenem s kisikom). Preprečuje se z ustreznim kliničnim upravljanjem, ki ne spada na področje uporabe tega mednarodnega standarda. OPOMBA: standard ISO/TR 11991 podaja smernice za preprečevanje požarov zaradi dihalnih cevk.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2017
1DGRPHãþD
SIST EN ISO 5366-1:2009
$QHVWH]LMVNDLQGLKDOQDRSUHPD7UDKHRVWRPVNHFHYNHLQSULNOMXþNL ,62
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO
5366:2016)
AAnästhesie- und Beatmungsgeräte - Tracheotomietuben (ISO 5366:2016)
Matériel d'anesthésie et de réanimation respiratoire - Raccords et tubes de
trachéostomie (ISO 5366:2016)
Ta slovenski standard je istoveten z: EN ISO 5366:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5366
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5366-1:2009
English Version
Anaesthetic and respiratory equipment - Tracheostomy
tubes and connectors (ISO 5366:2016)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Raccords et tubes de trachéostomie (ISO 5366:2016) Tracheotomietuben und Verbindungsstücke (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 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 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 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 COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN ISO 5366:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 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.
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 national 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 supersedes 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 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 by CEN as EN ISO 5366:2016 without any modification.
INTERNATIONAL ISO
STANDARD 5366
First edition
2016-10-01
Anaesthetic and respiratory
equipment — Tracheostomy tubes and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Raccords et
tubes de trachéostomie
Reference number
ISO 5366:2016(E)
©
ISO 2016
ISO 5366:2016(E)
© ISO 2016, Published in Switzerland
All 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 intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 5366:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 *General requirements for tracheostomy tubes and connectors .3
5 Materials . 4
6 Design requirements for tracheostomy tubes and connectors . 4
6.1 General design requirements . 4
6.2 Size designation and dimensions . 4
6.2.1 *Designated size . 4
6.2.2 Outside dimension . 5
6.2.3 Nominal length . 5
6.3 Design . 5
6.3.1 Connector . 5
6.3.2 Neck plate . 6
6.3.3 Inner tube . 6
6.3.4 *Cuffs . 7
6.3.5 Inflating tubes for cuffs . 7
6.3.6 Cuff inflation indicator . 7
6.3.7 *Inflating tube . 7
6.3.8 Patient end . 8
6.3.9 Introducer . 8
6.3.10 *Radiopaque marker . 8
6.3.11 *Kink resistance . 8
7 Requirements for tracheostomy tubes supplied sterile . 8
7.1 Sterility assurance . 8
7.2 Packaging for tracheostomy tubes supplied sterile . 9
8 Information supplied by the manufacturer . 9
8.1 General . 9
8.2 Marking of neck-plate . 9
8.3 Marking on the inflation indicator . 9
8.4 Marking of tracheostomy tube connectors .10
8.5 Additional labelling of unit packs .10
8.6 Labelling of inner tube unit packs .10
8.7 Labelling of tracheostomy tube inserts .10
Annex A (informative) Rationale .12
Annex B (normative) Test method for the security of attachment of a fitted connector and
neck-plate to the tracheostomy tube .14
Annex C (normative) Test method for determining the diameter of the cuff .16
Annex D (normative) Test method for cuff herniation .17
Annex E (normative) Test method for determining kink resistance .19
Annex F (informative) Guidance on materials and design .21
Annex G (informative) Hazard identification for risk assessment .22
Bibliography .25
ISO 5366:2016(E)
Foreword
ISO (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 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) on all matters of
electrotechnical standardization.
The procedures used to develop this document and
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.