SIST EN ISO 5361:2013

SLOVENSKI STANDARD
SIST EN ISO 5361:2013
01-januar-2013
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SIST EN 1782:2000+A1:2009
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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
SIST EN ISO 5361:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5361:2013

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SIST EN ISO 5361:2013


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.

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
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.
3

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
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.
4

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
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
6
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)
5

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
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.

6

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SIST EN ISO 5361:2013
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

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SIST EN ISO 5361:2013
ISO 5361:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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

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SIST EN ISO 5361:2013
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 2012 – All rights reserved iii

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SIST EN ISO 5361:2013
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

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SIST EN ISO 5361:2013
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.
© ISO 2012 – All rights reserved v

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SIST EN ISO 5361:2013

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SIST EN ISO 5361:2013
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 2012 – All rights reserved 1

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SIST EN ISO 5361:2013
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

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SIST EN ISO 5361:2013
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 2012 – All rights reserved 3

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SIST EN ISO 5361:2013
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
proc
...