EN ISO 5361:2012

SLOVENSKI STANDARD
01-januar-2013
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2012)
Ta slovenski standard je istoveten z: EN ISO 5361:2012
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.

EUROPEAN STANDARD
EN ISO 5361
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Tracheal tubes and
connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2012) Verbindungsstücke (ISO 5361:2012)
This European Standard was approved by CEN on 15 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5361:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 5361:2012) 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 2013, and conflicting national standards shall be withdrawn at the
latest by October 2015.
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 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 5361:2012 has been approved by CEN as a EN ISO 5361:2012 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 mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of
Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, 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.
NOTE 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 European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
5.3 7.1 (2nd indent) In the EU, competent authorities always
require applicable ERs.
4.1.6 7.1 (3rd indent)
5.3.1 7.2 7.1 and 7.2 covers the integrity of the
packaging only for devices supplied
7.1
sterile.
7.2
4.1.1 7.3 4.1.1, 4.1.2, and 5.3 mandates a risk
assessment be carried out which does not
4.1.2
exclude risks associated with materials
and the substances with which they may
5.3
come into contact. Does not cover
devices intended to administer medicinal
products.
5.3.4 7.5 Partly addressed by 5.3.4 and 8.3.1 m),
calls specifically for a warning if
8.3.1 m)
phthalates are incorporated. However,
justification for the use of phthalates for
use with children or pregnant or nursing
women is not covered.
7.2 8.1 7.2 mandates the requirements of ISO
11607-1 to ensure that the packaging is

suitable to prevent contamination during
transportation and use.
7.2 8.3 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.
7.1 8.4 7.1 mandates that sterile devices satisfy
4.1 of EN 556-1.
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
7.1 8.5 7.1 mandates that sterile devices satisfy
4.1 of EN 556-1.
8.3.1 h) 8.7 Partly covered. Marked sterile if
appropriate.
5.2.2 9.1 Generally covered by mandating
construction and testing of the interface
5.5.4, 5.9, 5.5.1
connector, resistance to tube collapse
and kinking, and cuff leakage.
5.1 9.2 (first and second indent) Partly covered to address only the risk of
injury in connection with their physical
5.2
features by specifying sizing and marking
conventions for the ID/OD of the tracheal
Tables 1a), 1b), and 1c)
tube, curvature of the tube, marking for
5.5
the OD of the cuff, and pressure limits for
cuff performance testing.
5.7
8.3.2 b)
8.2.1.1 d), e), and f) 10.1 (first sentence) Partly covered to address length
measurement and marking in cm. Limits
of accuracy are specified in the standard
and not disclosed by the manufacturer.
8.2.1.1 d), e), and f) 10.2 Length marking positions are mandated to
provide ergonomic angular visibility during
intubation.
8.2.1.1 d), e), and f) 10.3 Length marking is mandated using SI
units (cm).
5.2.2.5 12.7.4 Tracheal tube gas connectors are
mandated to comply with ISO 5356-1 for
5.6.5
15 mm connectors.
Tracheal tube cuff inflation connectors are
mandated to comply with ISO 594-1 for
Luers.
8 13.1 Covered by mandating marking and
labelling and instructions on the tube,

connector, unit label, and instructions for
use. 4.2.1 Safety note draws attention to
4.2.1 NOTE
consideration of disclosure of specific

labelling and instructions for intended use
that may deviate from the currently
accepted medical practice.
8.1 13.2 Symbols are mandated in 8.1 to conform
to EN 1041 and ISO 7000 or EN 980 or
ISO 15223-1 and ISO 15223-2.
8.2.1.1 a) 13.3 a) Manufacturer identification mandated on
the device and on individual pack or any
8.3.1 f)
insert. Authorised representative
mandated on the individual pack or any

insert.
7.2 13.3 b) Only identifies that the device is sterile (if
applicable).
8.3.1 h)
8.3.1 h) 13.3 c)
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
8.3.1 g) 13.3 d) Batch code preceded by the word “LOT”
mandated for EU countries.
8.3.1 g) 13.3 e) ‘Use by date’ is only addressed via a
‘strong’ recommendation; The EU
regulation makes it mandatory.

8.3.1 i) 13.3 f)
4.2.1 NOTE 13.3 j) 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.
8.3.1 h) NOTE 13.3 m) This NOTE is mandatory to cover this ER.
8.4 13.5 Limited to detachable connectors, which
are marked with the designated tracheal
tube size.
8 13.6, a), b), c) Mandated markings, labelling and
instructions.
8.3.1 l) 13.6 h), first and second Mandated instructions for cleaning and
paragraphs 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
8.3.2 a) 13.6 i) Details for preparation for use are
mandated for disclosure.
8.3.2 c) 13.6 q) The date of issue of the latest revision of
instructions for use is mandated.

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 5361
Second edition
2012-10-01
Anaesthetic and respiratory equipment —
Tracheal tubes and connectors
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
Reference number
ISO 5361:2012(E)
©
ISO 2012
ISO 5361:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 5361:2012(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
5.3 *Materials .14
5.4 Tracheal tube bevel .15
5.5 *Tracheal tube cuffs .15
5.6 Inflating system for cuffs .16
5.7 Curvature of the tube .16
5.8 *Radiopaque marker .18
5.9 *Kink resistance .18
6 Additional requirement for tracheal tubes with a Murphy eye .19
6.1 Size of the Murphy eye .19
6.2 Location of the Murphy eye .19
6.3 Resistance to kinking or collapse of the Murphy eye .19
6.4 Surface characteristics of the Murphy eye .19
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile .20
7.1 Sterility assurance .20
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile .20
8 Marking .20
8.1 Use of symbols .20
8.2 Tracheal tubes .20
8.3 Marking on the tracheal tube individual pack or any insert .21
8.4 Marking on tracheal tube connectors .23
Annex A (informative) Rationale .24
Annex B (normative) Determination of cuff diameter .28
Annex C (normative) Test method for cuffed tube collapse .29
Annex D (normative) *Test method for cuff herniation.32
Annex E (informative) Guidance on design of tracheal tube connectors .34
Annex F (informative) Hazard identification for risk assessment .35
Annex G (normative) *Test method for tracheal seal .38
Annex H (normative) Test method to determine kink resistance .41
Bibliography .43
ISO 5361:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
This second edition cancels and replaces the first edition (ISO 5361:1999), which has been technically revised.
The requirements of ISO 5361-4, Tracheal tubes — Part 4: Cole type, have been included in this second
edition because Cole type tracheal tubes are specialized tubes, and as such, are now included in the scope
of this International Standard.
Throughout this Particular Standard, terms defined in Clause 3 or in ISO 4135 appear in bold type.
Throughout this Particular Standard, text for which a rationale is provided in Annex A is indicated by an
asterisk (*).
iv © ISO 2012 – All rights reserved

ISO 5361:2012(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 convey gases and vapours to and from the trachea.
Tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration of secretions and to
provide an unobstructed airway in patients during spontaneous, assisted, or controlled ventilation for short or
prolonged durations.
A variety of cuff designs are available to meet particular clinical requirements. Cuff performance requirements
with associated test methods have been added to this second edition.
Requirements for paediatric tracheal tubes with cuffs have been added 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 have also been added to 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 have been added to this 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 5361:2012(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
or 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.
Tracheobronchial (endobronchial) 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.
[1][2][3][4]
NOTE ISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this .
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
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
1)
ISO 7000, Graphical symbols for use on equipment – Index and synopsis
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135-1, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for 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, 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
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
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?=.
ISO 5361:2012(E)
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 980, Symbols for use in the labelling of medical devices
EN 1041, Terminology, symbols and information provided with medical devices: Information supplied by the
manufacturer of medical devices
ASTM F640-2007, Standard test methods for radiopacity for medical use
ASTM D3002-2007, Standard guide for evaluation of coatings applied to plastics
3 Terms and definitions
[5]
For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 14971 and the
following apply.
3.1
angle of bevel
acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end
[ISO 4135:2001, definition 6.3.5]
See Figures 1 a), 1 b) and 4.
3.2
bevel
slanted portion at the patient end of a tracheal tube
[ISO 4135:2001, definition 6.3.4]
See Figures 1 a), 1 b) and 4.
3.3
Cole-type tracheal tube
tracheal tube combining a short laryngo-tracheal portion of small diameter and a longer oral portion of
larger diameter with transition from one to the other resulting in a shoulder
See Figure 1 c).
3.4
cuff
inflatable balloon permanently attached around the tracheal tube near the patient end and used to provide
an effective seal between the tube and the trachea
See Figures 1 a) and 1 b).
3.5
inflating tube
tube through which the cuff is inflated
[ISO 4135:2001, definition 6.3.6.1]
See Figures 1 a) and 1 b).
3.6
inflation lumen
lumen within the wall of the tracheal tube for inflating the cuff
2 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
3.7
laryngo-tracheal portion
that portion of a Cole-type tracheal tube of small diameter and extending from the bevel tip to the point at
which there is an increase in the outside diameter
3.8
machine end
that end of a tracheal tube which is intended to project from a patient
[ISO 4135:2001, definition 6.3.3]
See Figures 1 a), 1 b) and 4.
3.9
machine end of the tracheal tube connector
that portion of the tracheal tube connector intended to mate with an anaesthetic breathing system (ABS) or
ventilator breathing system (VBS)
3.10
Magill-type tracheal tube
curved tracheal tube with a radius without a Murphy eye and having a bevel at the patient end
See 5.7.2 and Figures 1 a), 1 b) and 4.
3.11
Murphy eye
hole through the wall of a tracheal tube near the patient end and on the side opposite to the bevel
See Figure 6.
3.12
naso-tracheal tube
tracheal tube for insertion through the nose into the trachea
[ISO 4135:2001, definition 6.3.1.2]
3.13
oral portion
that portion of a Cole-type tracheal tube of a larger diameter extending from the machine end to the point at
which there is a decrease in the outside diameter
3.14
oro-tracheal tube
tracheal tube for insertion through the mouth into the trachea
[ISO 4135:2001, definition 6.3.1.1]
3.15
patient end
that end of a tracheal tube which is intended to be inserted into the trachea
[ISO 4135:2001, definition 6.3.2]
See Figures 1 a), 1 b) and 4.
3.16
patient end of the connector
that end of the tracheal tube connector intended to be inserted into the tracheal tube
ISO 5361:2012(E)
3.17
pilot balloon
balloon fitted to an inflating tube to indicate inflation of the cuff
[ISO 4135:2001, definition 6.3.6.2]
See Figure 1 b).
3.18
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO 14971:2007, definition 2.16]
3.19
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[ISO 14971:2007, definition 2.17]
NOTE 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).
3.20
risk assessment
overall process comprising a risk analysis and a risk evaluation
[SO 14971:2007, definition 2.18]
3.21
risk evaluation
process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
[ISO 14971:2007, definition 2.21]
3.22
risk management
systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,
controlling and monitoring risk
[ISO 14971:2007, definition 2.22]
3.23
risk management file
set of records and other documents that are produced by risk management
[ISO 14971:2007, definition 2.23]
3.24
shoulder
that portion of a Cole-type tracheal tube at which transition from the oral portion to the laryngo-tracheal
portion occurs
3.25
single-fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
3.26
tracheal tube
tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea
[ISO 4135:2001, definition 6.3.1]
4 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
3.27
tracheal tube connector
tubular component that fits directly into the machine end of a tracheal tube
[ISO 4135:2005, definition 6.3.8]
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.
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.
ISO 5361:2012(E)
4.2 Safety
*4.2.1 Tracheal tubes, when transported, stored, installed, 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 Tables 1a and 1b.
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.
NOTE 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
1 2
Figure 1 c)], shall not exceed 4 mm for sizes up to and including size 3.
6 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
Table 1a —*Basic dimensions of tracheal tubes
(see Figures 1a and 1b)
Dimensions in millimetres
Dimension A Dimension C
a, b
Dimension S
Minimum length of tube Maximum distance from
Minimum distance of
Designated size [see Figure 1 a) and b)] the patient end of the
point of separation of the
(nominal inside tracheal tube to
inflating tube from the
diameter) the machine end of the
a patient end of the tube
Nasal or oral/nasal Oral
b
inflatable length of the cuff
[see Figures 1 a) and 1 b)]
[see Figures 1 a) and 1 b)]
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 5361:2012(E)
Table 1b — Basic dimensions of Cole-type tracheal tubes
(see Figure 1c)
Dimensions in millimetres
Oral portion
B
a
Length of
Designated size
laryngo-tracheal Overall length
(nominal inside Outside
Inside
portion A
diameter of tracheal diameter
diameter
C
portion) of the oral portion
d
d d
1 3
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.
8 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
Key
1 patient end 5 machine end
2 angle of the bevel (see 5.4) 6 alternative integral pilot balloon/valve assembly
3 radius of curvature (see 5.7) 7 separating angle (see 5.6.2)
4 inflating tube 8 region for marking size [see 8.2.1.1 b)]
9 inflatable length of cuff
a
See 5.6.6.
b
See Table 1a.
c
Minimum value for S = A − S .
2 1
Figure 1 a) — Typical cuffed Magill-type tracheal tube
ISO 5361:2012(E)
Key
1 patient end 5 machine end
2 angle of the bevel (see 5.4) 6 pilot balloon
3 radius of curvature (see 5.7) 7 separating angle (see 5.6.2)
4 inflating tube 8 region for marking size [see 8.2.1.1 b)]
9 inflatable length of cuff
a
See 5.6.6.
b
See Table 1a.
c
Minimum value for S = A − S .
2 1
Figure 1 b) — Typical cuffed Magill-type tracheal tube showing alternative design features
10 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
Key
1 patient end
2 maximum distance of start of curvature from beginning of taper S , 20 mm max. (See 5.7.4)
3 radius of curvature, approximately 60 mm (see 5.7.4)
4 angle of the curvature of the tube from the machine end to the patient end, (45 ± 15) ° (see 5.7.4)
5 machine end
6 region for marking, 20 mm min. [see 8.2.1.1 b)]
7 shoulder region for dimension S S (see 5.2.1.5)
1 2
8 smooth reduction of lumen (see 5.7.6)
9 maximum outside diameter of the laryngo-tracheal portion that is marked (OD) [see 8.2.1.1 b) 2)]
NOTE For dimensions A, B, C, d , d , and d , see Table 1 b)
1 2 3
Figure 1 c) — Cole-type tracheal tube
5.2.2 Tracheal tube connectors
NOTE The tracheal tube connector may incorporate a suction port.
5.2.2.1 The basic dimensions of tracheal tube connectors shall be in accordance with Table 2.
5.2.2.2 When a tracheal tube is supplied with a tracheal tube connector, the designated size of the connector
shall be not less than that of the tracheal tube with which it is provided.
5.2.2.3 The minimum inside diameter of a curved or angled tracheal tube connector shall be not less than 80 %
of the designated size, and the corresponding cross-sectional area shall not be reduced by more than 10 %.
5.2.2.4 A suction port, if provided, shall be designed so that its closure does not obstruct or narrow the lumen of
the tracheal tube connector.
ISO 5361:2012(E)
5.2.2.5 The machine end of the tracheal tube connector shall be a male 15 mm conical connector complying
with ISO 5356-1.
5.2.2.6 The inside diameter of the (conical) machine end of the tracheal tube connector shall be not less than
that allowed by Table 2 for the patient end. Any transition in the inside diameter shall be tapered to permit an
adequate lead-in for smooth passage of a suction catheter.
5.2.2.7 The basic dimensions of the patient end of the tracheal tube connector (see Figures 2 and 3) shall be
in accordance with Table 2. For curved tracheal tube connectors (Figure 3) angle θ shall be greater than 45°.
5.2.2.8 The opening at the patient end shall have a plane at (90 ± 5)° to the long axis of the patient end of the
tracheal tube connector.
Table 2 — Tracheal tube connectors — Size range and basic dimensions of patient end
Dimensions in millimetres
Straight connectors — Curved connectors —
Designated size Inside diameter minimum dimension l minimum dimension l
1 2
a a
(nominal inside diameter) d (±0,15) (effective length)  (effective length)
(Figure 2) (Figure 3)
2,0 2,0 9 —
2,5 2,5 9 —
3,0 3,0 9 —
3,5 3,5 11 —
4,0 4,0 11 —
4,5 4,5 12 —
5,0 5,0 12 —
5,5 5,5 13 10
6,0 6,0 13 10
6,5 6,5 16 10
7,0 7,0 16 10
7,5 7,5 16 10
8,0 8,0 16 10
8,5 8,5 16 10
9,0 9,0 16 10
9,5 9,5 16 10
10,0 10,0 16 10
10,5 10,5 16 10
11,0 11,0 16 10
a
The effective length of the patient end of a tracheal tube connector is that length available for insertion into the tracheal tube.
12 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
Key
1  machine end (see 5.2.2.5)
2  patient end
l effective length of the patient end of the straight tracheal tube connector
d  internal diameter of the tracheal tube connector
NOTE  This figure illustrates a tracheal tube connector for the purpose of defining basic dimensions, and is intended
as an example only.
Figure 2 — Straight tracheal tube connector
ISO 5361:2012(E)
Key
1  machine end (see 5.2.2.5)
2  patient end
l effective length of the patient end of the curved tracheal tube connector (see Table 2)
NOTE  This figure illustrates a tracheal tube connector for the purpose of defining basic dimensions, and is intended
as an example only.
Figure 3 — Example of a curved tracheal tube connector
5.3 *Materials
5.3.1 Those parts of the tracheal tube, including the cuff and tracheal tube connector in its ready-for-use
state, that come into contact with the patient’s ventilator gas pathway or mucous membranes, shall satisfy
appropriate biological safety testing, as indicated in ISO 10993-1.
5.3.2 The marking of tracheal tubes shall be durable and legible.
Check compliance by inspection, as indicated in 6.4.1 of ASTM D3002.
5.3.3 If intended and marked for reuse, tracheal tubes and tracheal tube connectors and marking materials used
on tracheal tubes should be resistant to deterioration by the methods of cleaning, disinfection and sterilization
recommended by the manufacturer. Such tracheal tubes shall withstand methods of sterilization recommended
14 © ISO 2012 – All rights reserved

ISO 5361:2012(E)
by the manufacturer. The recommended method or methods of sterilization shall not produce changes in the
materials which will compromise the biological safety of the tracheal tube and tracheal tube connector.
Check compliance by inspection of the risk management file.
5.3.4 If required by a compete
...