SIST EN ISO 5366:2017
(Main)Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
This 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.
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,
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.
AAnästhesie- und Beatmungsgeräte - Tracheotomietuben (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
SIST EN ISO 5366:2017
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
SIST EN ISO 5366:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5366:2017
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SIST EN ISO 5366:2017
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.
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SIST EN ISO 5366:2017
EN ISO 5366:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5366:2017
EN ISO 5366:2016 (E)
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.
3
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SIST EN ISO 5366:2017
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SIST EN ISO 5366:2017
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
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 5366:2017
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 2016 – All rights reserved iii
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SIST EN ISO 5366:2017
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 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 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 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 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 assessment,
as well as information about ISO’s 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 and 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 reserved
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
Introduction
This International Standard provides 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 aspiration 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 delivery 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 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 patient’s 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 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. 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 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 does 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 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 resist 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.
Throughout 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;
— 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 v
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SIST EN ISO 5366:2017
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SIST EN ISO 5366:2017
INTERNATIONAL STANDARD ISO 5366:2016(E)
Anaesthetic and respiratory equipment — Tracheostomy
tubes and connectors
1 *Scope
This 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.
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,
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.
2 Normative references
The 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 latest edition of the referenced document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on
Medical Devices in the Magnetic Resonance Environment
ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
NOTE See Figure 1 for illustrations of typical tracheostomy tubes and associated nomenclature.
3.1
angle of bevel
angle between the plane of the bevel (3.2) and the longitudinal axis of a tracheostomy tube (3.13)
3.2
bevel
slanted portion at the patient end (3.12) of a tracheostomy tube (3.13)
© ISO 2016 – All rights reserved 1
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
3.3
cuff
inflatable balloon around a tracheostomy tube (3.13) near the patient end (3.12) to provide a seal
between the tube and the trachea
3.4
inflating tube
tube through which a cuff (3.3) is inflated
3.5
inflation indicator
pilot balloon
device attached to an inflating tube (3.4) to indicate cuff inflation
3.6
inner tube
tube or cannula which fits closely to the inside contours of an outer tube (3.11)
3.7
introducer
stylet to facilitate the introduction of an outer tube (3.11) into the trachea
3.8
machine end
end of a tracheostomy tube (3.13) which is intended to project from the neck of a patient
3.9
neck-plate
part of a tracheostomy tube which is used to secure the tube in position
3.10
nominal length
distance from the patient side of the neck-plate (3.9) to the patient end (3.12) along the centre line
3.11
outer tube
part of a tracheostomy tube (3.13) which is normally in contact with the tissues
3.12
patient end
end of a tracheostomy tube (3.13) which is intended to be inserted into the trachea
3.13
tracheostomy tube
tube designed for insertion into the trachea through a tracheostomy
2 © ISO 2016 – All rights reserved
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
6
1
8
2
7
3
9
β
4
5
a) b)
Key
1 inflating tube 8 outer tube
2 neck-plate 9 inflation indicator
3 cuff 10 inflation valve or closure device
4 patient end 11 tip
5 inflation indicator/pilot balloon 12 bevel
6 breathing system connector β angle of bevel (see 6.3.7)
7 machine end l clamping length (see 6.3.7.2)
1
Figure 1 — Typical tracheostomy tube
a) b)
Key
Θ angle formed between the long axes of the tracheostomy tube at the machine end and the patient end
NOTE Figure 2 a) nominal length = b + c + a; Figure 2 b) nominal length = c.
Figure 2 — Basic dimensional datum references of a tracheostomy tube
4 *General requirements for tracheostomy tubes and connectors
4.1 Tracheostomy tubes and connectors shall satisfy the general requirements for airways and
related equipment for risk management, usability, clinical evaluation and biophysical or modelling
research listed in ISO 18190.
© ISO 2016 – All rights reserved 3
l₁
l₁
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
NOTE Annex G covers hazard identification for risk assessment of tracheostomy tubes.
Check compliance by the relevant requirements in ISO 18190.
4.2 The manufacturer may use type tests different from those detailed within this International
Standard if an equivalent degree of safety is obtained. Alternative test methods shall be validated against
the test methods specified in this International Standard.
Check compliance by inspection of the manufacturer’s technical file.
5 Materials
Tracheostomy tubes and connectors shall satisfy the general requirements for materials specified in
ISO 18190:2016, Clause 5.
Check compliance by the relevant requirements in ISO 18190.
6 Design requirements for tracheostomy tubes and connectors
6.1 General design requirements
Tracheostomy tubes and connectors shall satisfy the general design requirements for airways and
related equipment specified in ISO 18190.
Check compliance by the relevant requirements in ISO 18190.
6.2 Size designation and dimensions
6.2.1 *Designated size
Designated sizes of tracheostomy tubes shall be within the tolerances for the internal dimensions
specified in Table 1, including the connector, if fitted according to 6.3.1.1, but excluding any
encroachment allowed by 6.3.5 a).
Check compliance by functional testing.
4 © ISO 2016 – All rights reserved
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
Table 1 — Size designations of tracheostomy tubes: Dimensions and tolerances
Dimensions in millimetres
Designated size Nominal internal Designated size Nominal internal
dimension and dimension and
tolerance tolerance
2,0 2,0 + 0,2/–0,0 6,5 6,5 ± 0,2
2,5 2,5 + 0,2/–0,0 7,0 7,0 ± 0,2
3,0 3,0 + 0,2/–0,0 7,5 7,5 ± 0,2
3,5 3,5 + 0,2/–0,0 8,0 8,0 ± 0,2
4,0 4,0 + 0,2/–0,0 8,5 8,5 ± 0,2
4,5 4,5 + 0,3/–0,0 9,0 9,0 ± 0,2
5,0 5,0 + 0,3/–0,0 9,5 9,5 ± 0,2
5,5 5,5 + 0,3/–0,0 10,0 10,0 ± 0,2
6,0 6,0 + 0,3/–0,0 10,5 10,5 ± 0,2
11,0 11,0 ± 0,2
>11,0 >11,0 ± 0,2
6.2.2 Outside dimension
The actual measurement, of a and b (see Figure 2), shall be at the widest cross-sectional dimension
along its length (excluding any protuberance caused by inflating tube, suction line, etc., other than at
the cuff, if provided), shall be the marked outside dimension subject to a tolerance of ±0,2 mm.
The actual outside dimension of section c shall be the marked outside dimension subject to a tolerance
of +/-0,5 mm.
Check compliance by functional testing.
NOTE The outside dimension relates to that portion of the tube intended to be within the wall and the lumen
of the trachea.
6.2.3 Nomin al length
The nominal length, [see Figures 2 a) and b)], shall be within ±1,5 mm of the manufacturer’s declared
length [see 8.2.1 d)] for tubes with a designated size of <4,5 mm and within ±2,0 mm for tubes with
a designated size of ≥4,5 mm measured from the patient side of the neck-plate to the patient end
including the bevel, if present, and expressed in millimetres.
Check compliance by functional testing.
6.3 Design
6.3.1 Connector
6.3.1.1 Tracheostomy tubes or their inner tubes designed for use with a breathing system shall be
fitted, at the machine end, with a conical connector having a 15 mm cone complying with ISO 5356-1.
The connector shall not detach from the tracheostomy tube or inner tube at a separation force <50 N
−1
when applied at a rate of (50 ± 5) mm min .
Check compliance by the test method given in Annex B.
© ISO 2016 – All rights reserved 5
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SIST EN ISO 5366:2017
ISO 5366:2016(E)
6.3.1.2 The minimum inside diameter of the connector shall be ≥ the designated size of the
tracheostomy tube.
Check compliance by functional testing.
6.3.1.3 Any transition in inside diameter shall be tapered to facilitate the passage of a device (e.g.
suction catheter).
Check compliance by inspection.
6.3.1.4 Assessment of the risk of misconnection between the ID of the 15 mm connector to the
ISO 80369 series small-bore connector‚ shall be addressed by the manufacturer during the risk
management process. Reduction of the risk should be addressed by design if practicable.
Check compliance by inspection of the risk management file.
6.3.2 Neck plate
6.3.2.1 A non-adjustable neck-plate shall not detach from the tracheostomy tube at an axial force of
−1
<50 N applied at a rate of (50 ± 5) mm min .
Check compliance by the test method given in Annex B.
6.3.2.2 An adjustable neck-plate shall not move, when in a locked position, at an axial force of <15 N
−1
applied at a rate of (50 ± 5) mm min .
Check compliance by the test meth
...
SLOVENSKI STANDARD
oSIST prEN ISO 5366:2015
01-oktober-2015
$QHVWH]LMVNDLQGLKDOQDRSUHPD7UDKHRVWRPVNHFHYNHGHO &HYNHLQSULNOMXþNL
]DRGUDVOH ,62',6
Anaesthetic and respiratory equipment - Tracheostomy tubes (ISO/DIS 5366:2015)
Anästhesie- und Beatmungsgeräte - Tracheotomietuben (ISO/DIS 5366:2015)
Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie (ISO/DIS
5366:2015)
Ta slovenski standard je istoveten z: prEN ISO 5366
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5366:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5366:2015
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oSIST prEN ISO 5366:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5366
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-08-13 2015-11-13
Anaesthetic and respiratory equipment — Tracheostomy
tubes —
Part :
Tubes and connectors for use in adults
Matériel d’anesthésie et de réanimation respiratoire — Tubes de trachéostomie —
Partie : Tubes et raccords pour utilisation chez les adultes
ICS: 11.040.10
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ISO/DIS 5366:2015(E)
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
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ISO/DIS 5366:2015(E)
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© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
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ISO 5366
6 © ISO 2014
7 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
8 utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or
9 posting on the internet or an intranet, without prior written permission. Permission can be requested
10 from either ISO at the address below or ISO's member body in the country of the requester.
11 ISO copyright office
12 Case postale 56 • CH-1211 Geneva 20
13 Tel. + 41 22 749 01 11
14 Fax + 41 22 749 09 47
15 E-mail copyright@iso.org
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17 Published in Switzerland.
18 Contents
19 This template allows you to work with default MS Word functions and styles. You can use these if you
20 want to maintain the Table of Contents automatically and apply auto-numbering if this is your
21 preference. Delete this Table of Contents if not required.
22 Foreword . 7
23 Introduction. 9
24 1 *Scope . 10
25 2 Normative references . 10
26 3 Terms and definitions . 10
27 4 *General Requirements for TRACHEOSTOMY TUBES and connectors . 13
28 5 Materials . 13
29 6 Design requirements for TRACHEOSTOMY TUBES and connectors . 13
30 6.1 General design requirements . 13
31 6.2 Size designation and dimensions. 13
32 6.2.1 *Designated size . 13
33 6.2.2 Outside dimension . 14
34 6.2.3 Nominal length . 14
35 6.3 Design. 14
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36 6.3.1 Connector . 14
37 6.3.2 NECK-PLATE . 15
38 6.3.3 INNER TUBE . 15
39 6.3.5 INFLATING TUBES for CUFFS . 16
40 6.3.6 Cuff inflation indicator . 16
41 6.3.7 *Inflating tubes . 16
42 6.3.8 PATIENT END . 16
43 6.3.9 INTRODUCER . 16
44 6.3.10 *Radiopaque marker . 17
45 6.3.11 *Kink resistance . 17
46 7 Requirements for TRACHEOSTOMY TUBES supplied sterile . 17
47 7.1 Sterility assurance . 17
48 7.2 Packaging for TRACHEOSTOMY TUBES supplied sterile . 17
49 8 Marking and labelling . 18
50 8.1 General . 18
51 8.2 Marking of NECK- PLATE . 18
52 8.3 Marking on the INFLATION INDICATOR . 18
53 8.4 Marking of TRACHEOSTOMY TUBE connectors . 18
54 8.5 Additional labelling of unit packs . 19
55 8.6 Labelling of inner tube unit packs . 19
56 8.7 Labelling of TRACHEOSTOMY TUBE inserts . 19
57 In addition to the general labelling requirements of ISO 18190, the following shall be marked on
58 the TRACHEOSTOMY TUBE insert: . 19
59 Annex A (informative) Rationale . 21
60 A.1 Scope . 21
61 A.4 General Requirements for TRACHEOSTOMY TUBES and connectors . 21
62 A.5 Materials . 21
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63 A.6.2.1 Designated size . 21
64 A.6.3.4 CUFFS . 22
65 A.6.3.7 Inflating tubes . 22
66 A.6.3.10 Radiopaque marker . 22
67 A.6.3.11 Kink resistance . 22
68 Annex B (normative) Test method for the security of attachment of a fitted connector and NECK-
69 PLATE to the TRACHEOSTOMY TUBE . 23
70 B.1 Principle . 23
71 B.2 Apparatus . 23
72 B.3 Procedure . 23
73 Annex C (normative) Test method for determining the diameter of the CUFF . 24
74 C.1 Principle . 24
75 C.2 Apparatus . 24
76 C.3 Procedure . 24
77 C.4 Expression of results . 24
78 Annex D (normative) Test method for CUFF herniation . 25
79 D.1 Principle . 25
80 D.2 Apparatus . 25
81 D.3 Procedure . 25
82 D.4 Expression of results . 26
83 Annex E (normative) Test method for leakage past the CUFF . 27
84 E.1 Principle . 27
85 E.2 Apparatus . 27
86 E.3 Procedure . 27
87 Annex F (normative) Test method for determining kink resistance . 30
88 F.1 Principle . 30
89 F.2 Apparatus . 30
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90 F.3 Procedure . 30
91 Annex G (informative) Guidance on materials and design . 32
92 G.1 Materials . 32
93 G.2 Design . 32
94 Annex H (informative) Hazard identification for risk assessment. 33
95 H.1. Potential hazards associated with the placement, removal and use of TRACHEOSTOMY TUBES: 33
96 H.2. Potential device hazards . 33
97 Bibliography . 35
98 Annex ZA (informative) Relationship between this document and the Essential Requirements of
99 EU Directive 93/42/EEC . 36
100
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101 Foreword
102 ISO (the International Organization for Standardization) is a worldwide federation of national
103 standards bodies (ISO member bodies). The work of preparing International Standards is normally
104 carried out through ISO technical committees. Each member body interested in a subject for which a
105 technical committee has been established has the right to be represented on that committee.
106 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
107 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
108 matters of electrotechnical standardization.
109 The procedures used to develop this document and those intended for its further maintenance are
110 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
111 different types of ISO documents should be noted. This document was drafted in accordance with the
112 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
113 Attention is drawn to the possibility that some of the elements of this document may be the subject of
114 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
115 any patent rights identified during the development of the document will be in the Introduction and/or
116 on the ISO list of patent declarations received. www.iso.org/patents
117 Any trade name used in this document is information given for the convenience of users and does not
118 constitute an endorsement.
119 For an explanation on the meaning of ISO specific terms and expressions related to conformity
120 assessment, as well as information about ISO's adherence to the WTO principles in the Technical
121 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
122 The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
123 Subcommittee SC 2, Airways and related equipment.
124 This fifth edition cancels and replaces the fourth edition, ISO 5366-1:2000, which has been technically
125 revised.
126 The requirements of ISO 5366-3:2001 and ISO 5366-3 Corr:2003, Tracheostomy tubes – Part 3:
127 Paediatric tracheostomy tubes, have been included in this fifth edition.
128 Throughout this International Standard the following print types are used:
129 Requirements and definitions: roman type;
130 Test specifications: italic type;
131 Informative material appearing outside of tables, such as notes, examples and references: smaller
132 type. The Normative text of tables is also in smaller type;
133 TERMS DEFINED IN CLAUSE 3: SMALL CAPS.
134 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
135 that there is guidance or rationale related to that item in Annex A.
136 The attention of Member Bodies and National Committees is drawn to the fact that equipment
137 manufacturers and testing organizations may need a transitional period following publication of a new,
138 amended or revised ISO or IEC publication in which to make products in accordance with the new
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139 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
140 the committee that the content of this publication be adopted for implementation nationally not earlier
141 than 3 years from the date of publication for equipment newly designed and not earlier than 5 years
142 from the date of publication for equipment already in production.
143
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144 Introduction
145 This standard provides the essential requirements for the design of cuffed and uncuffed TRACHEOSTOMY
146 TUBES and connectors. These devices are intended to be inserted through a stoma in the trachea to
147 convey gases and vapours to and from the trachea. Cuffed devices are designed to seal and protect the
148 trachea from aspiration and to provide an unobstructed airway in patients during spontaneous,
149 assisted, or controlled ventilation for short or prolonged durations. Specialized tubes with walls
150 reinforced with metal or nylon, tubes with shoulders, tapering tubes, tubes with provision for
151 suctioning or monitoring or delivery of drugs or other gases, and the many other types of TRACHEOSTOMY
152 TUBES devised for specialized applications are included in this specification, as many specialized
153 TRACHEOSTOMY TUBES are now commonly used, and all share similar essential requirements defined in
154 this International Standard.
155 The method of describing tube dimensions and configuration has been devised in order to assist
156 clinicians in the selection of the most suitable tube for a particular patient's anatomy. Size is designated
157 by the internal dimension, which is important because of its relationship to resistance to gas flow.
158 Because stoma and tracheal sizes are also an important factor when selecting a TRACHEOSTOMY TUBE it is
159 considered essential that the outside dimension for each size of tube is also made known to the user.
160 Cuffed TRACHEOSTOMY TUBES can be characterized by a combination of the tube inside and outside
161 dimensions and by the diameter of the CUFF to be marked.
162 A variety of CUFF designs are available to meet particular clinical requirements. CUFF performance
163 requirements with associated test methods, which are aligned with the requirements in ISO 5361,
164 Tracheal tubes and connectors have been added to this fifth edition.
165 Requirements for paediatric TRACHEOSTOMY TUBES have been included in this fifth edition because they
166 share many common requirements that can be standardized and which are important for patient safety.
167 An infant or child differs from an adult, not only in size but also with regard to airway anatomy and
168 respiratory physiology; thus airway equipment for paediatric patients differs from that for adults, both
169 in size and in basic design. It does not require the connector to be permanently attached to the tube, as
170 this can be impractical with infants and small children. Other acceptable methods of connecting these
171 components are available, and this standard makes provision for them. This standard does not limit the
172 range of tube designs needed to match the variations in paediatric anatomy, lesions and space
173 limitations encountered.
174 Kink resistance requirements with associated test methods have also been added to this fifth edition to
175 measure the ability of the shaft of the TRACHEOSTOMY TUBE to resist collapse and increased breathing
176 resistance when bent or curved. These new requirements are aligned with the requirements in ISO
177 5361, Tracheal tubes and connectors (under development).
178 Requirements for TRACHEOSTOMY TUBES that are common to other airway and related devices have been
179 removed from this fifth edition as these are now included in ISO 18190 General requirements for
180 airways and related equipment, which is cross referenced where appropriate.
181
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182 Anaesthetic and respiratory equipment – Tracheostomy tubes
183 1 *Scope
184 This International standard specifies requirements for adult and paediatric TRACHEOSTOMY TUBES and
185 connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial
186 ventilation or other respiratory support.
187 This International standard is also applicable to specialized TRACHEOSTOMY TUBES that share common
188 attributes , for example those without a connector at the MACHINE END intended for spontaneously
189 breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders,
190 tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.
191 Flammability of TRACHEOSTOMY TUBES is a well-recognized hazard (for example when electrosurgical
192 units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is
193 addressed by appropriate clinical management and is outside the scope of this International standard.
194 NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.
195 2 Normative references
196 The following documents, in whole or in part, are normatively referenced in this document and are
197 indispensable for its application. For dated references, only the edition cited applies. For undated
198 references, the latest edition of the referenced document (including any amendments) applies.
199 ISO 4135, Anaesthetic and respiratory equipment — Vocabulary.
200 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
201 ISO/DIS 18190, General requirements for airways and related equipment (under development)
202 ISO/DIS 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
203 Connectors with 6% (Luer) taper for intravascular or hypodermic applications (under development)
204 ASTM F 640-12, Standard Test Methods for Determining Radiopacity for Medical Use
205 ASTM F 2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on
206 Medical Devices in the Magnetic Resonance Environment
207 ASTM F 2503. Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance
208 Environment
209 3 Terms and definitions
210 For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
211 NOTE See Figure 1 for illustrations of typical TRACHEOSTOMY TUBES and associated nomenclature.
212 3.1
213 ANGLE OF BEVEL
214 angle between the plane of the BEVEL and the longitudinal axis of a TRACHEOSTOMY TUBE
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215 3.2
216 BEVEL
217 slanted portion at the PATIENT END of a TRACHEOSTOMY TUBE
218 3.3
219 CUFF
220 inflatable balloon around a TRACHEOSTOMY TUBE near the PATIENT END to provide a seal between the tube
221 and the trachea
222 3.4
223 INFLATING TUBE
224 tube through which a CUFF is inflated
225 3.5
226 INFLATION INDICATOR/PILOT BALLOON
227 device attached to an INFLATING TUBE to indicate the extent of CUFF inflation
228 3.6
229 INNER TUBE
230 tube or cannula which fits closely to the inside contours of an OUTER TUBE
231 3.7
232 INTRODUCER
233 stylet to facilitate the introduction of an OUTER TUBE into the trachea
234 3.8
235 MACHINE END
236 that end of a TRACHEOSTOMY TUBE which is intended to project from the neck of a patient
237 3.10
238 NECK-PLATE
239 that part of a TRACHEOSTOMY TUBE which is used to secure the tube in position
240 3.11
241 NOMINAL LENGTH
242 NECK-PLATE to the PATIENT END along the centre line
Distance from the patient side of the
243 3.12
244 OUTER TUBE
245 that part of a TRACHEOSTOMY TUBE which is normally in contact with the tissues
246 3.13
247 PATIENT END
248 that end of a TRACHEOSTOMY TUBE which is intended to be inserted into the trachea
249 3.14
250 TRACHEOSTOMY TUBE
251 tube designed for insertion into the trachea through a tracheostomy
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252
253 Figure 1 a) Figure 1 b)
254 Figure 1 typical TRACHEOSTOMY TUBES
Key
1 INFLATING TUBE 7 MACHINE END
2 NECK-PLAT
...
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