EN ISO 5367:2014

SLOVENSKI STANDARD
01-januar-2015
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SIST EN 12342:2000+A1:2009
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Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de
connecteurs (ISO 5367:2014)
Ta slovenski standard je istoveten z: EN ISO 5367:2014
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 5367
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.10 Supersedes EN 12342:1998+A1:2009
English Version
Anaesthetic and respiratory equipment - Breathing sets and
connectors (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Systèmes respiratoires et raccords (ISO 5367:2014) Verbindungsstücke (ISO 5367:2014)
This European Standard was approved by CEN on 18 July 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5367:2014 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 5367:2014) 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 2015, and conflicting national standards shall be withdrawn at the
latest by October 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12342:1998+A1:2009.
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.
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 5367:2014 has been approved by CEN as EN ISO 5367:2014 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 one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC.
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 and associated EFTA regulations.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
standard.
Table ZA 1 — Correspondence between this European Document and Directive 93/42/EEC
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
5.1 7.1 (2nd, and 3rd indents)
4.3
5.1.1 7.2 5.1.1 mandates that these devices shall satisfy
the biological safety testing indicated in
7.1
ISO 10993-1
7.2
7.1 and 7.2 covers the integrity of the packaging
only for devices supplied sterile
4.1.1 7.3 first part 4.1.1, 4.1.2, and 5.1 mandates a risk
4.1.2 assessment be carried out which does not
exclude risks associated with materials and the
5.1
substances with which they may come into
contact.
5.1.3, 7.5 Partly addressed by 5.1.3 and 8.3.m) calls
8.3.m) specifically for a warning if phthalates are
incorporated
7.1, 8.1 Partly addressed. 7.1 and 8.3.a) mandate that
sterile devices are clearly marked according to
7.2,
EN 556–1 mandates the requirements of
8.3.a) 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
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
7.1 8.5
8.3.a) 8.7 Partly covered. Marked sterile if appropriate
5.3  9.1 Generally covered by mandating construction
5.4 and testing of the interface connectors, leakage,
resistance, compliance, resistance to tube
5.5
collapse and kinking.
5.6
5.2 Partly covered to address only the risk of injury
9.2 (first three indents)
in connection with their physical features by
5.3
specifying sizing and marking conventions for
5.4
the ID/OD of the breathing tubes, and leakage,
resistance, and compliance when performance
5.5
tested in accordance with parameters
5.6
associated with a declared patient category.
8.3 c)
8.3 d), e), f), g), m)
8.4.1
8.4.2
8.4.3
8.4.5
5.3.1 12.7.4 Partly addressed for conical gas connectors
only.
5.3.2
5.3.3
5.3.5
5.3.6
8 13.1
8.1
8.2
8.3
8.4
8.1 13.2 Generally covered. Symbols are mandated in
8.1 to conform to EN 1041, ISO 7000 or
ISO 15223-1
8.2 a) 13.3 a)
8.3 i)
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
8.3 c) 13.3 b) Covered for patient category, length, resistance,
total compliance and internal diameter.
8.3 d)
8.3 e) and f)
8.3 g)
8.3 h)
8.3 a) 13.3 c)
8.3 j) 13.3 d)
8.3.k) 13.3 e)
8.3.b) 13.3 f)
8.4.2 13.3 j) Partly addressed with requirements for
instructions for typical components or
8.4.3
processes.
8.4.4
8.4.5
8.3 l) 13.3 k)
8.3 m)
8.3 a) 13.3 m) Partly addressed. Method of sterilization is
addressed only as a recommendation.
8.4.5 13.5 Partly addressed. Limited to detachable
connectors, which are sized in accordance with
ISO 5356-1 instructs users on coaxial integrity
testing
8, 8.1, 8.2, 8.3, 8.4 13.6 , a), b), c)
8.4.4 13.6 h) Partly addressed. Risks associated with the
reuse of devices marked for single use are
8.3 l)
covered partly by the risk management file and
use of the informative Annex F Hazard
identification for risk assessment
8.4.5 13.6 i) Partly addressed. Details for coaxial set user
tests are mandated
8.4.6 13.6 q)
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
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard
INTERNATIONAL ISO
STANDARD 5367
Fifth edition
2014-10-15
Anaesthetic and respiratory
equipment — Breathing sets and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Systèmes
respiratoires et raccords
Reference number
ISO 5367:2014(E)
©
ISO 2014
ISO 5367:2014(E)
© ISO 2014
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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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 5367:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 4
4.3 Clinical evaluation . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
4.6 Recommended service life . 5
5 Specific requirements . 5
5.1 Materials . 5
5.2 Length . 5
5.3 Means of connection . 6
5.4 Leakage . 7
5.5 Resistance to flow . 7
5.6 Compliance . 8
6 Prevention of electrostatic charges . 9
7 Requirements for breathing sets and breathing tubes supplied sterile .9
7.1 Sterility assurance . 9
7.2 Packaging of breathing sets and breathing tubes supplied sterile. 9
8 Marking .10
8.1 General .10
8.2 Marking of breathing sets and breathing tubes .10
8.3 Marking of packages .10
8.4 Information to be supplied by the manufacturer .12
Annex A (informative) Rationale .13
Annex B (informative) Hazard identification for risk assessment .23
Annex C (normative) Test for security of attachment of plain end to conical connector .24
Annex D (normative) Test for security of attachment of adaptor to breathing tube .25
Annex E (normative) Test for leakage .26
Annex F (normative) Measurement of resistance to flow .28
Annex G (normative) Test for increase in flow resistance with bending .31
Annex H (normative) Test for compliance .33
Bibliography .35
ISO 5367:2014(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 fifth edition cancels and replaces the fourth edition (ISO 5367:2000), which has been technically
revised.
The following major changes were made:
— title and scope;
— additional normative references;
— additional terms and definitions;
— additional general requirements, including risk management, usability, clinical and biophysical
research;
— requirements for coaxial tubing, revised leakage limits, and testing for flow resistance and
compliance;
— revised limits for prevention of electrostatic charges;
— revised requirements for marking of packaging, including the use of symbols, disclosure of intended
patient category, flow resistance and compliance;
— added an annex for rationale;
— added an annex for hazard identification for risk assessment;
— revised test method annexes for resistance to flow, security of attachments, leakage and compliance;
— added an annex for compliance with the EU Directives.
iv © ISO 2014 – All rights reserved

ISO 5367:2014(E)
Introduction
This International Standard contains requirements for breathing sets, breathing tubes, and connectors
that are intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets
and breathing tubes are characterized by certain design requirements such as a means of connection
and leakage limits. Disclosure requirements for compliance and flow resistance values allow the user
to make an informed choice when connecting these accessories to a breathing system. These design
requirements are intended to allow operation within the limits of performance of the anaesthetic
breathing systems and ventilator breathing systems with which the accessories are intended to
operate.
This International Standard includes requirements for both single-use and reusable breathing sets
and breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the
requirements of this International Standard for the recommended service life.
Certain tests are performed under constant pressure to simplify the test methodology. It is recognized
that this does not reflect clinical use, where pressure is intermittent and peak pressures occur for short
periods. The limits in the test methods take this into account. While such test methods do not address
product variability, the limits required also take this into account.
Terms defined in this International Standard are set in bold type.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
Throughout this International Standard, all pressures are denoted in SI units of hPa with corresponding
cmH O equivalent values rounded to the nearest whole cmH O.
2 2
NOTE The unit cmH O is not an SI notation and is not used in ISO documents; rounded cmH O values are
2 2
given for information only to allow comparison to medical literature and related breathing system standards.
INTERNATIONAL STANDARD ISO 5367:2014(E)
Anaesthetic and respiratory equipment — Breathing sets
and connectors
1 Scope
*This International Standard specifies basic requirements for breathing sets and breathing tubes
intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers
or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied
already assembled and to those supplied as components and assembled in accordance with the
manufacturer’s instructions.
This International Standard is applicable to breathing sets which include special components (e.g.
water traps) between the patient end and machine end which are supplied already assembled.
This International Standard is not applicable to breathing sets and breathing tubes for special
purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets
and breathing tubes suitable for use with patient end adaptors.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat
and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by
this International Standard.
[3] [4] [1]
NOTE 2 ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1 , ISO 23328-2 , and ISO 5362 cover these.
[2]
NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185 .
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.
NOTE See Annex A for information on the use of dated and undated normative references.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
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 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 5367:2014(E)
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 60417, Graphical symbols for use on equipment
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential
performance – Collateral standard: Usability
IEC 62366, Medical devices — Application of usability engineering to medical devices
ISO 80601-2-12:2011, Medical electrical equipment — Part 2-12: Particular requirements for basic safety
and essential performance of critical care ventilators
ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety
and essential performance of an anaesthetic workstation
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 with medical devices
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
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible
components
[SOURCE: ISO 4135:2001, 4.2.3.1]
3.2
anaesthetic breathing system
inspiratory and expiratory gas pathways through which anaesthetic gas flows at respiratory pressure
between the fresh-gas inlet, the patient connection port and an exhaust valve or exhaust port
[SOURCE: ISO 80601-2-13:2011, 201.3.203]
3.3
antistatic
property of a material or procedure that disperses or inhibits the accumulation of electrostatic charges
3.4
APL valve
adjustable pressure-limiting valve
pop-off valve
pressure-limiting valve which releases gas over an adjustable range of pressures
[SOURCE: ISO 4135:2001, 4.3.6, modified]
3.5
assembled end
end of a breathing tube incorporating an adaptor
2 © ISO 2014 – All rights reserved

ISO 5367:2014(E)
3.6
breathing set
assembly of breathing tubes, connectors and components that form the inspiratory and expiratory
limbs of the gas pathways of an anaesthetic or ventilator breathing system between the ventilator
and the patient’s airway device
Note 1 to entry: The exhaust valve, heat and moisture exchanger (HME), breathing filter, and reservoir bag are
not included.
Note 2 to entry: The patient connection port is included.
3.7
breathing tube
non-rigid tube used to convey gases and/or vapours between components of a breathing system
[SOURCE: ISO 4135:2001, 4.1.2]
3.8
compliance
volume added per unit pressure increase when gas is added to an enclosed space, expressed at the
temperature and humidity of that enclosed space and at ambient atmospheric pressure
[SOURCE: ISO 4135:2001, 3.1.5]
3.9
machine end
that end of the breathing set or breathing tube intended to be connected to the anaesthetic workstation,
ventilator or other breathing system component furthest from the patient
[SOURCE: ISO 4135:2001, 4.2.3.2, modified]
3.10
patient connection port
opening at the patient end of a breathing system intended for connection of an airway device such
as a tracheal or tracheostomy tube connector, a face mask, a supralaryngeal airway or a test apparatus
[SOURCE: ISO 4135:2001, 4.2.1.2, modified]
3.11
patient end
that end of the breathing set or breathing tube which is intended to be connected to the patient end
adaptor, Y-piece or other appropriate component near the patient
3.12
patient end adaptor
tubular connector with multiple ports, one of which is a patient connection port
Note 1 to entry: Examples of patient end adaptors include a Y-piece, a swivel adaptor, and other specialized
adaptors for coaxial, multiple tubes, and bifurcated tubes. See also Annex A, Figures A.1 to A.5.
3.13
plain end
end of a breathing tube designed to fit directly over a male conical connector complying with ISO 5356-1
3.14
swivel adaptor
specialized adaptor which allows variation in the position of its ports relative to each other
ISO 5367:2014(E)
3.15
ventilator breathing system
VBS
inspiratory or expiratory gas pathways through which gas flows at respiratory pressures and bounded
by the port through which fresh gas enters, the patient connection port and the exhaust port
[SOURCE: ISO 80601-2-12:2011, 201.3.221]
3.16
Y-piece
patient end adaptor as a three-way connector with a patient connection port and two ports for
connection to breathing tubes
[SOURCE: ISO 4135:2001, 4.2.2.2, modified]
4 General requirements
4.1 Risk management
4.1.1 This International Standard specifies requirements that are generally applicable to risks
associated with breathing sets and breathing tubes. An established risk management process shall be
applied to the design of the device.
NOTE An informative list of identified hazards is contained in Annex B.
4.1.2 Breathing 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 subsequently 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 It is recognized that the manufacturer may not be able to follow all of the processes identified in
this International Standard for each constituent component of the breathing tube, such as proprietary
components, subsystems of non-medical origin, and legacy devices. In this case, the manufacturer should
take special account of the need for additional risk control measures.
4.1.4 Where requirements of this International Standard refer to freedom from unacceptable risk,
acceptability or unacceptability is determined by the manufacturer in accordance with the manufacturer’s
policy for determining acceptable risk.
Check compliance by inspection of the risk management file.
4.2 Usability
If required by a competent authority, the manufacturer shall address in a usability engineering process
any risks resulting from poor usability (see IEC 60601-1-6 and IEC 62366).
Check compliance by inspection of the usability engineering file.
4 © ISO 2014 – All rights reserved

ISO 5367:2014(E)
4.3 Clinical evaluation
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 of the device.
4.4 Biophysical or modelling research
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 file.
4.5 Test methods
The manufacturer may use type tests different from those detailed within this International Standard,
if an equivalent degree of safety is obtained. However, in the event of dispute, the methods specified
herein shall be used as the reference methods.
4.6 Recommended service life
Re-usable breathing sets and breathing tubes shall comply with the requirements of this International
Standard throughout the recommended service life as required in 8.4.4.
Check compliance by inspection of the manufacturer’s technical file.
5 Specific requirements
5.1 Materials
5.1.1 Breathing sets and breathing tubes, in their ready-for-use condition after any preparation
recommended by the manufacturer, shall satisfy appropriate biological safety testing, in accordance with
ISO 10993-1.
5.1.2 Breathing sets and breathing tubes shall be made of materials suitable for their intended use
and, if applicable, shall function in the presence of commonly used concentrations of anaesthetic agents
and gases in accordance with their intended use.
5.1.3 If required by a competent authority and if phthalates are incorporated in parts of the medical
devices coming directly or indirectly into contact with the patient, the medical device shall be labelled
accordingly.
NOTE Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction.
5.1.4 If materials that contain natural rubber (latex) are incorporated in parts of the medical devices
coming directly or indirectly into contact with the patient, the medical device shall be labelled accordingly.
5.2 Length
5.2.1 The length of a breathing tube shall be designated by its nominal overall length, expressed
in metres, when measured in the resting condition (without extension), lying on a horizontal surface.
Breathing tubes intended to be extended when used shall be designated by both the unextended and
extended lengths.
ISO 5367:2014(E)
5.2.2 The designated length of a breathing tube provided attached to a Y-piece or patient end adaptor
shall include the length of the Y-piece or patient end adaptor and any assembled ends.
5.2.3 The actual length shall be within ± 10 % of the designated length.
5.3 Means of connection
5.3.1 General
5.3.1.1 Breathing tubes shall have plain ends complying with 5.3.2 and/or assembled ends with
adaptors incorporating 22 mm or 15 mm conical connectors complying with ISO 5356-1.
5.3.2 Plain ends of breathing tubes
5.3.2.1 The axial length [l in Figure 1 a)] of the plain ends of breathing tubes, excluding those
specified in 5.3.2.2, shall be not less than 21 mm for breathing tubes intended to engage with 22 mm
male conical connectors or not less than 14 mm for breathing tubes intended to engage with 15 mm
male conical connectors.
5.3.2.2 The axial length [l in Figure 1 a)] of the plain ends of breathing tubes that incorporate an
internal ridge [see Figure 1 b)], intended to engage with the recess at the base of a 22 mm male conical
connector as specified in ISO 5356-1, shall be not less than 26,5 mm.
5.3.2.3 When tested as described in Annex C, the plain ends of breathing tubes shall not become
detached from the appropriate male conical connector at a force of less than 40 N.
Figure 1 — Axial length of plain end of breathing tube
5.3.3 Adaptor
The end of the adaptor that is not intended for attachment to the breathing tube shall have a 22 mm or
15 mm conical connector complying with ISO 5356-1.
5.3.4 Assembled end
When tested as described in Annex D, the adaptor shall not detach from the breathing tube at a force
of less than 45 N.
NOTE For the purpose of this requirement, a patient end adaptor provided securely attached to a breathing
tube is regarded as an adaptor.
6 © ISO 2014 – All rights reserved

ISO 5367:2014(E)
5.3.5 Breathing tubes securely attached to a patient end adaptor
For breathing tubes supplied securely attached to a patient end adaptor, the patient connection
port of that patient end adaptor shall be a 22 mm male/15 mm female coaxial or 15 mm female conical
connector complying with ISO 5356-1.
5.3.6 Coaxial or double lumen breathing tubes securely attached to an adaptor
For coaxial or double-lumen breathing tubes supplied securely attached to an adaptor, the patient
connection port attached to or part of that adaptor shall be a 22 mm male/15 mm female coaxial or
15 mm female conical connector complying with ISO 5356-1.
5.4 Leakage
5.4.1 Leakage from breathing tubes supplied to be cut to length shall not exceed 10 ml/min at (60 ± 3)
hPa [(60 ± 3) cmH O], per metre length of tubing.
Check compliance by testing in accordance with Annex E.
5.4.2 *Leakage from a single breathing tube not intended for use with a VBS or anaesthetic breathing
system, shall not exceed 25 ml/min at (60 ± 3) hPa [(60 ± 3) cmH O].
Check compliance by testing in accordance with Annex E.
5.4.3 *Leakage from a complete breathing set or breathing tube supplied ready for use with a VBS
or anaesthetic breathing system shall not exceed the leakage limit listed for the designated patient
category in Table 1.
Check compliance by testing in accordance with Annex E.
*Table 1 — Leakage limit by patient category
At pressure
Leakage limit
Patient category Intended delivered volume hPa
ml/min
(cmH O)
Adult ≥ 300 ml 70 60 ± 3
Paediatric 50 ml < 300 ml 40 60 ± 3
Neonatal ≤ 50 ml 30 60 ± 3
NOTE See Annex E.
5.5 Resistance to flow
5.5.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
[see 8.4.1 a)] the resistance to flow per metre length of tubing at the flow listed for the designated patient
category in Table 2. The flow resistance shall not exceed the limit in Table 2.
Check compliance by testing in accordance with Annex F.
ISO 5367:2014(E)
*Table 2 — Flow resistance limit per metre by patient category for breathing tubes supplied to
be cut to length
Patient category Intended delivered volume Flow resistance limit At flow
hPa/l/min/m l/min
(cmH O/l/min/m)
Adult ≥ 300 ml 0,03 30
Paediatric 50 ml < 300 ml 0,06 15
Neonatal ≤ 50 ml 0,37 2,5
NOTE See Annex F.
5.5.2 *For a breathing tube supplied ready for use or for each limb of a breathing set, the manufacturer
shall determine, mark, and disclose [see 8.3 e) and 8.4.1 b)] the resistance to flow at the flow listed for the
designated patient category Table 3.
If the resistance exceeds the limit listed in Table 3 for the designated patient category, the risk shall be
assessed in the risk management file and, if required, marked and disclosed [see 8.3 e) and 8.4.1 b)].
Check compliance by testing in accordance with Annex F and, if required, by inspection of the risk management
file.
*Table 3 — Flow resistance limit by patient category for breathing sets and breathing tubes
supplied ready for use
Patient category Intended delivered volume Flow resistance limit At flow
hPa/l/min l/min
(cmH O/l/min)
Adult ≥ 300 ml 0,06 30
Paediatric 50 ml < 300 ml 0,12 15
Neonatal ≤ 50 ml 0,74 2,5
NOTE See Annex F.
5.5.3 Regarding the increase in flow resistance with bending, when tested in accordance with Annex G,
the pressure at the flow rate stated when the breathing tube is suspended over the metal cylinder shall
not exceed 150 % of the value obtained when the tube is straight .
5.6 Compliance
5.6.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
[see 8.4.1 d)] the compliance per metre of tubing at the pressure listed for the designated patient category
in Table 4. The compliance per metre of the tubing shall not exceed the limit in Table 4.
Check compliance by testing in accordance with Annex H.
8 © ISO 2014 – All rights reserved

ISO 5367:2014(E)
Table 4 — Compliance limit per metre by patient category for breathing tubes supplied to be cut
to length
Patient category Intended delivered volume Compliance limit At pressure
ml/hPa/m hPa
(ml/cmH O/m) (cmH O)
2 2
Adult ≥ 300 ml 0,8 60 ± 3
Paediatric 50 ml < 300 ml 0,7 60 ± 3
Neonatal ≤ 50 ml 0,3 60 ± 3
NOTE See Annex H.
5.6.2 *For a breathing set or breathing tube supplied ready for use, the manufacturer shall determine
mark, and disclose [See 8.3 g) and 8.4 e)] the total compliance at the pressure listed for the designated
patient category in Table 5.
If the compliance exceeds the limit listed in Table 5 for the designated patient category, the risk shall be
assessed in the risk management file and, if required, marked and disclosed [See 8.3 g) and 8.4 e)].
Check compliance by testing in accordance with Annex H and, if required, by inspection of the risk management
file.
Table 5 — Compliance limit by patient categoryfor breathing sets and breathing tubes supplied
ready for use
Patient category Intended Delivered Volume Compliance Limit At Pressure
ml ml/hPa hPa
(ml/cmH O) (cmH O)
2 2
Adult ≥ 300 ml 5 60 ± 3
Paediatric 50 ml < 300 ml 4 60 ± 3
Neonatal ≤ 50 ml 1,5 60 ± 3
NOTE See Annex H.
6 Prevention of electrostatic charges
* Antistatic breathing tubes and securely attached components that are for use with flammable
anaesthetic mixtures shall have an end-to-end electrical resistance of not less than 1 megaohm (1 MΩ)
and not more than 1 000 megaohm (1 000 MΩ) when tested in accordance with the requirements of
IEC 60601-1:2005, Annex G.
7 Requirements for breathing sets and breathing tubes supplied sterile
7.1 Sterility assurance
Breathing sets and breathing tubes supplied and marked “STERILE” shall satisfy the requirements of
subclause 4.1 of EN 556-1:2001.
7.2 Packaging of breathing sets and breathing tubes supplied sterile
7.2.1 Breathing sets and breathing tubes supplied and marked “STERILE” shall be contained in an
individual pack.
7.2.2 The pack shall serve as an effective barrier to the penetration of microorganisms and particulate
matter in accordance with ISO 11607-1.
ISO 5367:2014(E)
7.2.3 The pack shall not permit reclosure without clearly revealing that it has been opened.
8 Marking
8.1 General
a) If r
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