EN ISO 5361:2016

SLOVENSKI STANDARD
01-december-2016
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SIST EN ISO 5361:2013
SIST EN ISO 5361:2013/AC:2013
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Anästhesieund Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO
5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2016)
Ta slovenski standard je istoveten z: EN ISO 5361:2016
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 5361
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5361:2012
English Version
Anaesthetic and respiratory equipment - Tracheal tubes
and connectors (ISO 5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2016) Verbindungsstücke (ISO 5361:2016)
This European Standard was approved by CEN on 15 July 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 5361:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] . 5

European foreword
This document (EN ISO 5361:2016) 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 March 2017, and conflicting national standards shall
be withdrawn at the latest by September 2019.
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 5361:2012.
This document has been prepared under a mandate given to CEN by the European Commission 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.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes ZZ.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 594-1 EN 20594-1:1993 + ISO 594-1:1986
AC:1993 + A1:1997
ISO 5356-1 EN ISO 5356-1:2015 ISO 5356-1:2015
ISO 7000 ISO 7000:2014
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 11135 EN ISO 11135:20104 ISO 11135:2014
ISO 11137-1 EN ISO 11137-1:2015 ISO 11137-1:2006 + AMD
1:2013
ISO 11607-1 EN ISO 11607-1:2009 + ISO 11607-1:2006 + AMD
A1:2014 1:2014
ISO 14155 EN ISO 14155:2011 ISO 14155:2011 + CORR
1:2011
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
1 1
ISO 15223-1
EN 15223-1:— ISO 15223-1:2015
ISO 15223-2 — ISO 15223-2:2010
EN 556-1:2001 EN 556-1:2001 —
EN 1041 EN 1041:2008 + A1:2013 —
ASTM F640-2007 — —
ASTM D3002-2007 — —
1  The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more
information, consult http://www.iso.org/iso/publications_and_e-products/databases.htm?=.

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 5361:2016 has been approved by CEN as EN ISO 5361:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] / [M/295 concerning
the development of European Standards related to medical devices] / [reference number and title of
any other standardization request as relevant] to provide one voluntary means of conforming to
essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ
L 160].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/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 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this International Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.1 (2nd indent) 5.3 7.1 (second indent)
Partly Covered. There are no
7.1 (3rd indent) 4.1.6
requirements for materials
apart for e requirements to
perform a risk assessment.
7.2 5.3.1 7.1 and 7.2 covers the integrity
of the packaging only for
7.1
devices supplied sterile.
7.2
7.3 5.3.1 5.3.1 and 5.3.1
5.3.3 First part covered; does not
cover devices intended to
administer medicinal products.
7.5 (second paragraph) 5.3.4
8.3.1 m)
8.1 7.2 Covered only for packaging of
sterile devices.
8.3 7.2 Partly addressed by 7.2 which
mandates the requirements of
ISO 11607-1 that the
packaging is suitable to
prevent contamination during
transportation and use.
8.4 7.1 7.1 mandates that sterile
devices satisfy 4.1 of EN 556-1.
8.7 8.3.1 h) Partly covered. Marked sterile
if appropriate.
9.1 5.2.2 Generally covered by
mandating construction and
testing of the interface
connector.
9.2 (first and second indent) 5.1 Partly covered to address only
the risk of injury in connection
5.2
with their physical features by
Tables 1a), 1b), and 1c)
specifying sizing and marking
conventions for the ID/OD of
5.5
the tracheal tube, curvature of
5.7
the tube, marking for the OD of
the cuff, and pressure limits
for cuff performance testing.
8.3.2 b)
10.1 (first sentence) 8.2.1.1 d) Partly covered to address
length measurement and
marking in cm.
10.2 8.2.1.1 d) Partly addressed. Length
marking positions are
8.2.1.2
mandated to provide
ergonomic angular visibility
during intubation. Glottic
depth marks aid in intubation
positioning.
10.3 8.2.1.1 d), and e) Length marking is mandated
using SI units (cm).
12.7.4 5.2.2.5 Tracheal tube gas connectors
are mandated to comply with
5.6.5
ISO 5356-1 for 15 mm
connectors.
Tracheal tube cuff inflation
connectors are mandated to
comply with ISO 594-1 for
Luers.
13.1 8 Covered by mandating
marking and labelling and
instructions on the tube,
connector, unit label, and
instructions for use. 4.2.1
13.3 b) 7.2 Only identifies that the device
is sterile (if applicable).
8.3.1 b)
Marking of 8.3.1 b), c) and d)
8.3.1 c)
on the unit pack will further
8.3.1 d)
address this requirement.
8.3.1 h)
13.3 c) 8.3.1 h)
13.3 d) 8.3.1 g) Batch code preceded by the
word “LOT” mandated for EU
countries.
13.3 e) 8.3.1 g) ‘Use by date’ is only addressed
via a ‘strong’ recommendation;
The EU regulation makes it
mandatory.
13.3 f) 8.3.1 i) For full coverage of this ER, the
NOTE in 8.1.1 I) is mandatory.
13.3 j) 4.2.1 NOTE 4.2.1 Safety note draws
attention to consideration of
disclosure of specific labelling
and instructions for intended
use that may deviate from the
currently accepted medical
practice. This NOTE is
mandatory to cover this ER.
13.3 m) 8.3.1 h) NOTE This NOTE is mandatory to
cover this ER.
13.5 8.4 Limited to detachable
connectors, which are marked
with the designated tracheal
tube size.
13.6, a) 8
Covers the following details
referred to in section 13.3
13.3a), b), c), f), and j).
For 13.3 m) to be covered the
recommendation in 8.3.1 h) is
mandatory.
13.6, b) 8 Covered in full
13.6, c) 5.2.2.5 8.3.1 b) requires the
description of the contents. Per
8.3.1 b)
5.2.2.5 the connector is
mandated to be a 15mm male
connector.
13.6 h), first and second 8.3.1 l) Mandated instructions for
paragraphs cleaning and disinfection or
sterilization. Risks associated
with the reuse of devices
marked for single use are
covered partly by the risk
management file and use of the
informative Annex F Hazard
identification for risk
assessment
13.6 i) 8.3.2 a) Details for preparation for use
are mandated for disclosure.
13.6 q) 8.3.2 c) The date of issue of the latest
revision of instructions for use
is mandated.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
NOTE Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. 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.
INTERNATIONAL ISO
STANDARD 5361
Third edition
2016-09-01
Anaesthetic and respiratory
equipment — Tracheal tubes and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
Reference number
ISO 5361:2016(E)
©
ISO 2016
ISO 5361:2016(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
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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 5361:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *General requirements for tracheal tubes and tracheal tube connectors .5
4.1 Risk assessment . 5
4.2 Safety . 6
5 Specific requirements for tracheal tubes and tracheal tube connectors .6
5.1 Size designation . 6
5.2 Dimensions . 6
5.2.1 Tracheal tubes . 6
5.2.2 Tracheal tube connectors .10
5.3 *Materials .13
5.4 Tracheal tube bevel .13
5.5 *Tracheal tube cuffs .13
5.6 Inflating system for cuffs .14
5.7 Curvature of the tube .14
5.8 *Radiopaque marker .16
5.9 *Kink resistance .16
6 Additional requirement for tracheal tubes with a Murphy eye .17
6.1 Size of the Murphy eye .17
6.2 Location of the Murphy eye .17
6.3 Resistance to kinking or collapse of the Murphy eye .17
6.4 Surface characteristics of the Murphy eye .17
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile .17
7.1 Sterility assurance .17
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile .18
8 Marking .18
8.1 Use of symbols .18
8.2 Marking on the tracheal tube .18
8.3 Marking on the tracheal tube individual pack or any insert.19
8.4 Marking on tracheal tube connectors .21
Annex A (informative) Rationale .22
Annex B (normative) Determination of cuff diameter .26
Annex C (normative) Test method for cuffed tube collapse .27
Annex D (normative) *Test method for cuff herniation .30
Annex E (informative) Guidance on design of tracheal tube connectors .32
Annex F (informative) Hazard identification for risk assessment .33
Annex G (normative) *Test method for tracheal seal .36
Annex H (normative) Test method to determine kink resistance.39
Bibliography .41
ISO 5361:2016(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 WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This third edition cancels and replaces the second edition (ISO 5361:2012), which has been technically
revised.
Throughout this International Standard, terms defined in Clause 3 or in ISO 4135 appear in bold type.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
iv © ISO 2016 – All rights reserved

ISO 5361:2016(E)
Introduction
This International Standard provides the essential performance and safety requirements for the design
of tracheal tubes and tracheal tube connectors. Tracheal tubes are intended to be inserted through
the larynx into the trachea to provide a patent airway in patients during spontaneous, assisted or
controlled ventilation for short or prolonged durations to convey gases and vapours to and from the
trachea.
In addition, tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration.
A variety of cuff designs are available to meet particular clinical requirements. Cuff performance
requirements with associated test methods remain unchanged from the second edition.
Requirements for paediatric tracheal tubes, with and without cuffs, have been updated from the
second edition to include revised length marks and new provisions for glottic depth marks have been
added in this edition because these are commercially available and in common use.
Tracheal tubes are also intended to conform as closely as possible to human anatomy when in position.
Clinical considerations have also dictated the specified length of tracheal tubes because long tracheal
tubes, sometimes of relatively narrow diameter, may be required and, therefore, should be readily
available. Provision has also been included for pre-cut tracheal tubes.
Kink resistance requirements with associated test methods remain unchanged from the second edition
to measure the ability of the shaft of the tracheal tube to resist collapse and increased breathing
resistance when bent or curved.
Radiopacity requirements and test methods remain unchanged from the second edition to characterize
the visibility of tracheal tubes in X-rays used to determine proper placement of the tube. The
requirements of this International Standard were developed using the hazard identification for risk
assessment in Annex F.
INTERNATIONAL STANDARD ISO 5361:2016(E)
Anaesthetic and respiratory equipment — Tracheal tubes
and connectors
1 Scope
This International Standard provides essential performance and safety requirements for oro-tracheal
and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with
metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for
suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes
devised for specialized applications are included in this International Standard, as many specialized
tracheal tubes are now commonly used, and all share similar essential requirements as defined in this
International Standard.
Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways
are excluded from the scope of this International Standard.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical
equipment are outside the scope of this International Standard.
NOTE References [1] to [4] deal with laser surgery of the airway.
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.
1)
ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
2)
ISO 7000 , Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135, Sterilization of health care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
1) To be replaced by ISO 80369-7.
2) The graphical symbols in ISO 7000 are also available online in the ISO web store. For more information, consult
http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
ISO 5361:2016(E)
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information
to be supplied — Part 2: Symbol development, selection and validation
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer of medical devices
ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use
ASTM D3002-07, Standard Guide for Evaluation of Coatings Applied to Plastics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971 and the
following apply.
3.1
angle of bevel
acute angle between the plane of the bevel (3.2) and the longitudinal axis of the tracheal tube (3.27) at
the patient end (3.16)
[SOURCE: ISO 4135:2001, 6.3.5]
Note 1 to entry: See Figures 1a, 1b, and 4.
3.2
bevel
slanted portion at the patient end (3.16) of a tracheal tube (3.27)
[SOURCE: ISO 4135:2001, 6.3.4]
Note 1 to entry: See Figures 1a, 1b, and 4.
3.3
Cole-type tracheal tube
tracheal tube (3.27) combining a short laryngo-tracheal portion (3.8) of small diameter and a longer oral
portion (3.14) of larger diameter with transition from one to the other resulting in a shoulder (3.25)
Note 1 to entry: See Figure 1c.
3.4
cuff
inflatable balloon permanently attached around the tracheal tube (3.27) near the patient end (3.16) and
used to provide an effective seal between the tube and the trachea
Note 1 to entry: See Figures 1a and 1b.
3.5
glottic depth mark
indicator on the tracheal tube (3.27) to assist in determining the tip insertion depth beyond the
vocal cords
3.6
inflating tube
tube through which the cuff (3.4) is inflated
[SOURCE: ISO 4135:2001, 6.3.6.1]
Note 1 to entry: See Figures 1a and 1b.
2 © ISO 2016 – All rights reserved

ISO 5361:2016(E)
3.7
inflation lumen
lumen within the wall of the tracheal tube (3.27) for inflating the cuff (3.4)
3.8
laryngo-tracheal portion
that portion of a Cole-type tracheal tube (3.3) of small diameter and extending from the bevel (3.2) tip to
the point at which there is an increase in the outside diameter
3.9
machine end
that end of a tracheal tube (3.27) which is intended to project from a patient
[SOURCE: ISO 4135:2001, 6.3.3]
Note 1 to entry: See Figures 1a, 1b, and 4.
3.10
machine end of the tracheal tube connector
that portion of the tracheal tube connector (3.28) intended to mate with an anaesthetic breathing
system (ABS) or ventilator breathing system (VBS)
3.11
Magill-type tracheal tube
curved tracheal tube (3.27) with a radius and having a bevel (3.2) at the patient end (3.16)
Note 1 to entry: See 5.7.2 and See Figures 1a, 1b, and 4.
3.12
Murphy eye
hole through the wall of a tracheal tube (3.27) near the patient end (3.16) and on the side opposite to the
bevel (3.2)
Note 1 to entry: See Figure 6.
3.13
naso-tracheal tube
tracheal tube (3.27) for insertion through the nose into the trachea
[SOURCE: ISO 4135:2001, 6.3.1.2]
3.14
oral portion
that portion of a Cole-type tracheal tube (3.3) of a larger diameter extending from the machine end (3.9)
to the point at which there is a decrease in the outside diameter
3.15
oro-tracheal tube
tracheal tube (3.27) for insertion through the mouth into the trachea
[SOURCE: ISO 4135:2001, 6.3.1.1]
3.16
patient end
that end of a tracheal tube (3.27) which is intended to be inserted into the trachea
[SOURCE: ISO 4135:2001, 6.3.2]
Note 1 to entry: See Figures 1a, 1b, and 4.
ISO 5361:2016(E)
3.17
patient end of the connector
that end of the tracheal tube connector (3.28) intended to be inserted into the tracheal tube (3.27)
3.18
pilot balloon
balloon fitted to an inflating tube (3.6) to indicate inflation of the cuff (3.4)
[SOURCE: ISO 4135:2001, 6.3.6.2]
Note 1 to entry: See Figure 1b.
3.19
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2007, 2.16]
3.20
risk analysis
systematic use of available information to identify hazards and to estimate the risk (3.19)
[SOURCE: ISO 14971:2007, 2.17]
Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous
situations and harm (see Annex F and ISO 14971:2007, Annex E).
3.21
risk assessment
overall process comprising a risk analysis (3.20) and a risk evaluation (3.22)
[SOURCE: ISO 14971:2007, 2.18]
3.22
risk evaluation
process of comparing the estimated risk (3.19) against given risk criteria to determine the acceptability
of the risk
[SOURCE: ISO 14971:2007, 2.21]
3.23
risk management
systematic application of management policies, procedures, and practices to the tasks of analysing,
evaluating, controlling, and monitoring risk (3.19)
[SOURCE: ISO 14971:2007, 2.22]
3.24
risk management file
set of records and other documents that are produced by risk management (3.23)
[SOURCE: ISO 14971:2007, 2.23]
3.25
shoulder
that portion of a Cole-type tracheal tube (3.3) at which transition from the oral portion (3.14) to the
laryngo-tracheal portion (3.8) occurs
3.26
single-fault condition
condition in which a single means for reducing a risk (3.19) is defective or a single abnormal condition
is present
4 © ISO 2016 – All rights reserved

ISO 5361:2016(E)
3.27
tracheal tube
tube designed for insertion through the larynx into the trachea to convey gases and vapours to and
from the trachea
[SOURCE: ISO 4135:2001, 6.3.1]
3.28
tracheal tube connector
tubular component that fits directly into the machine end (3.9) of a tracheal tube (3.27)
[SOURCE: ISO 4135:2005, 6.3.8]
Note 1 to entry: See Figures 2 and 3.
4 *General requirements for tracheal tubes and tracheal tube connectors
This International Standard specifies requirements that are generally applicable to risks associated
with tracheal tubes and tracheal tube connectors.
4.1 Risk assessment
4.1.1 An established risk assessment process shall be applied to the design of the device.
EXAMPLE ISO 14971.
Check compliance by inspection of the risk management file. If clinical studies are performed, these
studies shall document measurements taken during the conditions for which performance is claimed.
The clinical studies shall comply with the requirements of ISO 14155.
NOTE See Annex F.
4.1.2 Tracheal tubes shall, when transported, stored, installed, operated in normal use, and
maintained according to the instructions of the manufacturer, present no risks that are not reduced to
an acceptable level using risk management procedures in accordance with ISO 14971 and which are
connected with their intended application, in normal and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable
risk. In that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific
risk control measures need to be determined within the risk management process to deal with such situations.
4.1.3 Where requirements in this International Standard refer to freedom from unacceptable risk, the
acceptability or unacceptability of this risk shall be determined by the manufacturer in accordance with
the manufacturer’s policy for determining acceptable risk.
Check compliance by inspection of the risk management file.
4.1.4 If required by a competent authority, the manufacturer shall address in a usability engineering
process the risk resulting from poor usability (see IEC 62366).
Check compliance by inspection of the usability engineering file.
4.1.5 If required by a competent authority, a clinical evaluation shall be performed and documented in
the technical documentation of the device.
Check compliance by inspection of the technical documentation.
ISO 5361:2016(E)
4.1.6 If required by a competent authority, and where appropriate, validated biophysical or modelling
research shall be carried out.
Check compliance by inspection of the technical documentation.
4.2 Safety
4.2.1 *Tracheal tubes, when transported, stored, inserted, operated in their normal intended use, and
maintained according to the instructions of the manufacturer, shall minimize safety hazards which could
reasonably be foreseen to occur, in normal and single-fault conditions.
Check compliance by inspection of the risk management file.
NOTE Attention is drawn to any intended use that may deviate from the currently accepted medical practice.
See Annex A for examples.
4.2.2 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.
5 Specific requirements for tracheal tubes and tracheal tube connectors
5.1 Size designation
The size of tracheal tubes and tracheal tube connectors shall be designated in accordance with
Table 1a for tracheal tubes, Table 1b for Cole-type tracheal tubes, and Table 2 for tracheal tube
connectors.
5.2 Dimensions
5.2.1 Tracheal tubes
5.2.1.1 The basic dimensions of Magill-type tracheal tubes shall be in accordance with Table 1a.
5.2.1.2 The basic dimensions of Cole-type tracheal tubes shall be in accordance with Table 1b.
5.2.1.3 The designated size of the tracheal tube shall be the marked inside diameter subject to a
tolerance of ±0,15 mm for sizes 6,0 and smaller, and subject to a tolerance of ±0,20 mm for sizes 6,5
and larger.
The lumen of the tracheal tube should be essentially circular in a plane at right angles to the long axis.
5.2.1.4 For Magill-type tracheal tubes, the nominal outside diameter (OD) shall be the marked
outside diameter (OD) subject to a tolerance of ±0,15 mm for sizes 6,0 and smaller, or subject to a
tolerance of ±0,20 mm for sizes 6,5 and larger [see 8.2.1.1 b) 1)]. For Cole-type tracheal tubes, the
maximum outside diameter of the laryngo-tracheal portion (OD) shall be the marked outside diameter
(OD) [see 8.2.1.1 b) 2)].
5.2.1.5 For Cole-type tracheal tubes, the axial length of the outside surface of the shoulder region, S
S (see Figure 1c), shall not exceed 4 mm for sizes up to and including size 3.
6 © ISO 2016 – All rights reserved

ISO 5361:2016(E)
Table 1a — *Basic dimensions of tracheal tubes (see Figures 1a and 1b)
Dimensions in millimetres
a, b
Dimension A Dimension C Dimension S
Designated
Minimum length of tube Maximum distance from the Minimum distance of point
size
(see Figures 1a and 1b) patient end of the tracheal of separation of the inflating
(nominal
tube to the machine end of tube from the patient end of
inside
a the inflatable length of the the tube (see Figures 1a and
Nasal or oral/nasal Oral
diameter)
b
cuff (see Figures 1a and 1b) 1b)
2,0 130 110 — —
2,5 140 110 — —
3,0 160 120 33 —
3,5 180 130 35 —
4,0 200 140 41 —
4,5 220 150 45 —
5,0 240 160 56 110
5,5 270 170 56 120
6,0 280 190 58 125
6,5 290 210 62 135
7,0 300 230 66 140
7,5 310 240 69 145
8,0 320 250 72 150
8,5 320 260 75 155
9,0 320 270 78 160
9,5 320 280 81 165
10,0 320 280 85 170
10,5 320 280 85 170
11,0 320 280 85 170
a
Manufacturers wishing to market packaged sterile tracheal tubes with tracheal tube connectors inserted are guided by the tube
lengths shown in the table. However, the user is cautioned that anatomical variations, conditions of use, the length of the tube inserted,
or other factors may result in the use of a tracheal tube either too long or too short for a given patient. Selecting the size and length of a
tracheal tube still requires expert clinical knowledge and judgment to ensure that it is appropriate to the needs of a specific patient.
b
Clinical literature suggests that a shorter Dimension C may decrease likelihood of endobronchial intubations for paediatric patients
(see Annex A).
ISO 5361:2016(E)
Table 1b — Basic dimensions of Cole-type tracheal tubes (see Figure 1c)
Dimensions in millimetres
Oral portion
B
Length of
a
Designated size
laryngo-
Outside
Overall length
(nominal inside
tracheal
Inside diameter
A
diameter of tracheal
portion
diameter of the oral
portion)
C
d portion
d
d
min max min max max min max
1,5 20 24 3,9 5,0 7,0 110 140
1,75 20 24 4,1 5,0 7,0 110 140
2,0 20 25 4,2 5,0 7,0 120 140
2,25 25 30 4,3 5,0 7,0 120 140
2,5 25 30 4,3 5,0 7,5 125 140
3,0 25 30 4,3 5,0 7,5 125 140
3,5 25 35 5,0 6,0 9,5 130 150
4,0 25 35 5,5 6,5 9,5 140 160
4,5 28 38 6,5 7,0 10,5 150 170
a
For convenience in size designation, the second decimal place may be omitted.
X
S
X 5
S
S
C
Key
1 patient end 7 separating angle (see 5.6.2)
2 angle of the bevel (see 5.4) 8 region for marking size [see 8.2.1.1 b)]
3 radius of curvature (see 5.7) 9 inflatable length of cuff
a
4 inflating tube See 5.6.6.
b
5 machine end See Table 1a.
c
6 alternative integral pilot balloon/valve assembly Minimum value for S = A − S .
2 1
Figure 1a — Typical cuffed Magill-type tracheal tube
8 © ISO 2016 – All rights reserved

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