SIST EN ISO 5367:2023
(Main)Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
This document specifies minimum 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 document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
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.
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2023)
Dieses Dokument legt die Mindestanforderungen für Atemsets und Atemschläuche fest, die zur Verwendung mit Anästhesie-Atemsystemen, Atemsystemen des Beatmungsgerätes, Anfeuchtern oder Verneblern vorgesehen sind. Es gilt für Atemsets und Atemschläuche und Adapter am Patientenende, die zusammengebaut geliefert werden, und für solche, die als Bauteile geliefert und nach Anleitung des Herstellers zusammengebaut werden.
Dieses Dokument gilt für Atemsets, die spezielle Bauteile (z. B. Wasserabscheider) zwischen dem Patientenende und dem Maschinenende enthalten, die bereits zusammengebaut geliefert werden.
Es sind koaxiale und verwandte bifurkierte, doppellumige oder mehrlumige Atemsets und Atemschläuche vorgesehen, die zur Verwendung mit Adaptern am Patientenende geeignet sind.
ANMERKUNG Beispiele verschiedener Typen von Beatmungsgeräten mit Adapter am Patientenende sind in Anhang A abgebildet.
Dieses Dokument gilt nicht für Atemsets und Atemschläuche für Spezialzwecke.
BEISPIEL 1 Beatmungsgeräte verfügen über spezielle Anforderungen an Compliance, Druck oder Atemfrequenz.
Anforderungen für Atemsystemkomponenten wie Ausatemventile, Abgasventile, einstellbare Druckbegrenzungsventile (APL-Ventile), Wärme- und Feuchtigkeitsaustauscher (HMEs), Atemfilter und Reservoirbeutel werden in diesem Dokument nicht behandelt, können jedoch in ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1 [3], ISO 23328-2 [4], und ISO 5362 [1] gefunden werden. Anforderungen für beheizte Atemschläuche sind in ISO 80601-2-74 [2] zu finden.
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et raccords (ISO 5367:2023)
Le présent document spécifie les exigences de base concernant les ensembles respiratoires et les tubes respiratoires destinés à être utilisés avec des systèmes d’anesthésie par voie respiratoire, des systèmes respiratoires de ventilateurs, des humidificateurs ou des nébuliseurs. Il s’applique aux ensembles respiratoires, aux tubes respiratoires et aux adaptateurs d’extrémité «patient» fournis déjà assemblés ainsi qu’à ceux qui sont fournis en tant que composants et assemblés conformément aux instructions du fabricant.
Le présent document s’applique aux ensembles respiratoires qui incluent des composants spéciaux (par exemple, pièges à eau) entre l’extrémité «patient» et l’extrémité «appareil».
Des dispositions ont été prises pour les ensembles respiratoires et les tubes respiratoires coaxiaux, à double branche, à double ou multiples lumières, destinés à être utilisés avec des adaptateurs d’extrémité «patient».
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5367:2023
01-oktober-2023
Nadomešča:
SIST EN ISO 5367:2015
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2023)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2023)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords (ISO 5367:2023)
Ta slovenski standard je istoveten z: EN ISO 5367:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5367:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5367:2023
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SIST EN ISO 5367:2023
EN ISO 5367
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5367:2014
English Version
Anaesthetic and respiratory equipment - Breathing sets
and connectors (ISO 5367:2023)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Ensembles respiratoires et raccords (ISO 5367:2023) Verbindungsstücke (ISO 5367:2023)
This European Standard was approved by CEN on 3 March 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5367:2023 E
worldwide for CEN national Members.
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SIST EN ISO 5367:2023
EN ISO 5367:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5367:2023
EN ISO 5367:2023 (E)
European foreword
This document (EN ISO 5367:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5367:2014.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5367:2023 has been approved by CEN as EN ISO 5367:2023 without any modification.
3
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SIST EN ISO 5367:2023
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SIST EN ISO 5367:2023
INTERNATIONAL ISO
STANDARD 5367
Sixth edition
2023-07
Anaesthetic and respiratory
equipment — Breathing sets and
connectors
Matériel d'anesthésie et de réanimation respiratoire — Ensembles
respiratoires et raccords
Reference number
ISO 5367:2023(E)
© ISO 2023
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Recommended service life . 2
5 Materials . 2
5.1 General . 2
5.2 Biological safety testing . 2
6 Design requirements .2
6.1 General . 2
6.2 Designated length . 2
6.3 Breathing tube ends . 3
6.4 Leakage . 4
6.5 Resistance to flow . . 4
6.6 Compliance . 5
6.7 Axial strength of breathing tubes . 6
7 Requirements for breathing sets and breathing tubes supplied sterile .6
8 Packaging. 6
9 Information supplied by the manufacturer . 6
9.1 General . 6
9.2 Marking on the packaging . 7
9.3 Instructions for use . 7
Annex A (informative) Rationale . 9
Annex B (informative) Hazard identification for risk management .14
Annex C (normative) Test for security of attachment of plain end to conical connector .15
Annex D (normative) Test for security of attachment of assembled ends and axial strength
of breathing tubes .16
Annex E (normative) Test for leakage .18
Annex F (normative) Measurement of resistance to flow .20
Annex G (normative) Test for increase in flow resistance with bending .23
Annex H (normative) Test for compliance .25
Bibliography .27
iii
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SIST EN ISO 5367:2023
ISO 5367:2023(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airway devices and related equipment, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory
and anaesthetic equipment, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 5367:2014), which has been technically
revised.
The main changes are as follows:
— the layout now follows the format of ISO 18190:2016;
— the general requirements such as risk management, usability, clinical investigation and some
common marking requirements have been removed as they are now in ISO 18190 and cross-
referenced in the appropriate clauses of this document.
— the list of normative references, many of which are cited in ISO 18190 has been updated.
— requirements for hose systems for neonatal applications were added (e.g. the 11,5 mm conical
connector according to ISO 5356-1).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
Introduction
This document 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 conformance 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 document includes requirements for both single-use and reusable breathing sets and breathing
tubes. Reusable breathing sets and breathing tubes are intended to conform to the requirements of this
document for the recommended service life.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
This document is not applicable to breathing sets and breathing tubes that are intended to be used only
for special purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 Patient Interface adapters with special connectors for neonatal ventilation, that are not
interfacing to a Tracheal tube.
Requirements for breathing system components such as exhalation valves, exhaust valves, adjustable
pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir
bags, are not covered by this document but can be found in ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1,
ISO 23328-2 and ISO 5362. Requirements for heated breathing tubes can be found in ISO 80601-2-74.
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 do take this into account.
Throughout this document, all pressures are denoted in SI units of hPa with corresponding cmH O
2
equivalent values rounded to the nearest whole cmH O.
2
NOTE 2 Rounded cmH O values are given for information only to allow comparison to medical literature and
2
related breathing system standards.
This document is written following the format of ISO 18190 which is the general standard for airways
and related equipment. The requirements in this device-specific standard take precedence over any
conflicting requirements in ISO 18190.
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SIST EN ISO 5367:2023
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SIST EN ISO 5367:2023
INTERNATIONAL STANDARD ISO 5367:2023(E)
Anaesthetic and respiratory equipment — Breathing sets
and connectors
1 Scope
This document specifies minimum 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 document is applicable to breathing sets which include special components (e.g. water traps)
between the patient end and machine end.
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
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 Figures A.1 to A.5.
3.2
plain end
end of a breathing tube designed to fit directly over a cone conical connector conforming to ISO 5356-1
1
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
4 General requirements
4.1 General
ISO 18190:2016, Clause 4 shall apply.
NOTE An informative list of identified hazards is contained in Annex B.
4.2 Recommended service life
Re-usable breathing sets and breathing tubes shall conform to the requirements of this document
throughout the recommended service life as required in 9.3.4.
Check conformance by inspection of the manufacturer’s technical documentation.
5 Materials
5.1 General
ISO 18190:2016, Clause 5 shall apply.
5.2 Biological safety testing
Breathing sets shall also be evaluated and tested in conformance with ISO 18562-1.
Check conformance by inspection of the manufacturer’s technical documentation.
6 Design requirements
6.1 General
ISO 18190:2016, Clause 6 shall apply.
6.2 Designated length
6.2.1 The length of breathing tubes shall be designated by their 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.
Check conformance by functional testing.
6.2.2 The designated length of breathing tubes provided securely attached to a Y-piece or patient end
adaptor shall include the length of the patient end adaptor and any assembled ends.
Check conformance by functional testing.
6.2.3 The actual length shall be within ±10 % of the designated length.
Check conformance by functional testing.
2
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
6.3 Breathing tube ends
6.3.1 Breathing tubes shall have plain ends or assembled ends
Check conformance by inspection.
NOTE There is rationale for this subclause in A.3.
6.3.2 Plain ends according to Figure 1 shall have axial lengths as specified in Table 1.
Check conformance by functional testing.
6.3.3 Plain ends shall not become detached from their respective cones when subjected to the axial
forces specified in Table 1.
Check conformance by the test given in Annex C.
a) Plain end with recess b) Plain end without recess
Figure 1 — Axial length of plain end of breathing tubes
Table 1 — Breathing tube end specifications
Axial lengths
Cone size Axial force
L L
1 2
(mm) (N)
(mm) (mm)
22 ≥21 ≥26,5 ≥40
15 ≥14 N/A ≥40
11,5 ≥10,5 N/A ≥25
NOTE The cone sizes are those specified in ISO 5356-1.
6.3.4 Adaptor
The end of the adaptor that is not intended for attachment to the breathing tube shall be a 22 mm or
15 mm or 11,5 mm socket conforming to ISO 5356-1.
Check conformance by inspection of the manufacturer’s technical documentation.
6.3.5 Assembled end
Adaptors shall not detach from the breathing tube at a force of less than:
a) 45 N for 15 mm and 22 mm adaptors; and
b) 30 N for 11,5 mm adaptors.
3
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
Adaptors for use in breathing sets or breathing tubes for neonatal ventilation using an 11,5 mm
ISO 5356-1 compliant socket conical connector shall not detach from the breathing tube at a force of
less than 30 N.
NOTE For the purpose of this requirement, a patient end adaptor provided securely attached to a breathing
tube is regarded as an adaptor.
Check conformance by the test given in Annex D.
6.3.6 Patient connection ports
Patient connection ports shall be one of the following:
a) a coaxial 22 mm cone/15 mm socket;
b) a 15 mm socket;
Check conformance by inspection of the manufacturer’s technical documentation.
6.4 Leakage
6.4.1 Leakage from breathing tubes shall not exceed 10 ml/min at (60 ± 3) hPa [(60 ± 3) cmH O].
2
Check conformance by the test given in Annex E.
6.4.2 Leakage from complete breathing sets shall not exceed the leakage limit listed for the designated
patient category in Table 2.
NOTE See also Annex A for rationale.
Check conformance by the test given in Annex E.
Apply 6.4.1 or 6.4.2, as applicable
Table 2 — Leakage limit by patient category
Patient category Intended delivered volume Leakage limit At pressure
ml/min hPa
(cmH O)
2
Adult ≥ 300 ml 70 60 ± 3
Paediatric 50 ml < 300 ml 40 60 ± 3
Neonatal ≤ 50 ml 30 60 ± 3
NOTE See Annex E.
6.5 Resistance to flow
6.5.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
[see 9.3.1 a)] the resistance to flow per metre length of tubing at the flow listed for the designated
patient category in Table 3. The flow resistance shall not exceed the limit in Table 3.
NOTE See also Annex A for rationale for Tables 3 and 4.
Check conformance by the test given in Annex F.
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
Table 3 — 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)
2
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.
6.5.2 For breathing tubes supplied ready for use or for each limb of a breathing set, the manufacturer
shall determine, mark, and disclose [see 9.2 c) and 9.3.1 b)] the resistance to flow at the flow listed for
the designated patient category specified in Table 4.
If the resistance exceeds the limit listed in Table 4 for the designated patient category, the risk shall be
assessed in the risk management file and, marked and disclosed [see 9.2 c) and 9.3.1 b)].
Check conformance by the test given in Annex F and, if required, by inspection of the manufacturer’s
risk management file.
Table 4 — Flow resistance limit by patient category for breathing sets and breathing tubes
supplied ready for use
Patient category Intended delivered Flow resistance limit At flow
volume
hPa/l/min l/min
(cmH O /l/min)
2
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.
6.5.3 The increase in flow resistance when breathing tubes are suspended over a rigid cylinder shall
not exceed 150 % of the value obtained when the tube is straight.
Check conformance by the test given in Annex G.
6.6 Compliance
6.6.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
[see 9.3.1 d)] the compliance per metre of tubing at the pressure listed for the designated patient
category in Table 5. The compliance per metre of the tubing shall not exceed the limit in Table 5.
Check conformance by the test given in Annex H.
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SIST EN ISO 5367:2023
ISO 5367:2023(E)
Table 5 — 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.
6.6.2 For breathing sets or breathing tubes supplied ready for use, the manufacturer shall determine
mark, and disclose [see 9.2 e) and 9.3.1 e)] the total compliance at the pressure listed for the designated
patient category in Table 5.
NOTE See also Annex A for rationale.
If the compliance exceeds the limit listed in Table 6 for the designated patient category, the risk shall be
assessed in the risk management file and, if required, marked and disclosed [see 9.2 e) and 9.3.1 e)].
Check conformance by the test given in Annex H and, by inspection of the manufacturer’s risk
management file.
Table 6 — Compliance limit by patient category for breathing sets and breathing tubes supplied
ready for use
Patient category Intended delivered volume Compliance limit At pressure
ml/hPa (ml/ cmH O) hPa
2
(cmH O)
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.
6.7 Axial strength of breathing tubes
Breathing tubes shall withstand an axial force of 45 N.
Check conformance by the test given in Annex D.
7 Requirements for breathing sets and breathing tubes supplied sterile
ISO 18190:2016, Clause 7 shall apply.
8 Packaging
ISO 18190:2016, Clause 8 shall apply.
9 Information supplied by the manufacturer
9.1 General
IS
...
SLOVENSKI STANDARD
oSIST prEN ISO 5367:2021
01-julij-2021
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO/DIS 5367:2021)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO/DIS
5367:2021)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO/DIS
5367:2021)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords (ISO/DIS 5367:2021)
Ta slovenski standard je istoveten z: prEN ISO 5367
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5367:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5367:2021
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oSIST prEN ISO 5367:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5367
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-03-30 2021-06-22
Anaesthetic and respiratory equipment — Breathing sets
and connectors
Matériel d'anesthésie et de réanimation respiratoire — Systèmes respiratoires et raccords
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5367:2021(E)
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 5367:2021
ISO/DIS 5367:2021(E)
1 © ISO 2017, Published in Switzerland
2 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
3 otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
4 internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
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6 ISO copyright office
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COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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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ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 5367:2021
ISO/DIS 5367:2021(E)
13 Contents
14 Foreword . iv
15 Introduction . v
16 1 Scope . 1
17 2 Normative references . 1
18 3 Terms and definitions . 1
19 4 General requirements . 3
20 4.1 General . 3
21 4.2 Test methods . 3
22 4.3 Recommended service life . 3
23 5 Materials . 4
24 5.1 General . 4
25 5.2 *Biological safety testing . 4
26 6 Design requirements . 4
27 6.1 General . 4
28 6.2 Designated length . 4
29 6.3 Means of connection . 4
30 6.4 Leakage . 5
31 6.5 Resistance to flow . 6
32 6.6 Compliance . 7
33 6.7 *Prevention of electrostatic charges . Error! Bookmark not defined.
34 7 Requirements for breathing sets and breathing tubes supplied sterile . 8
35 8 Packaging . 8
36 9 Information supplied by the manufacturer . 8
37 9.1 General . 8
38 9.2 Marking on the packaging . 8
39 9.3 Instructions for use . 9
40 Annex A (informative) Rationale . 10
41 Annex B (informative) Hazard identification for risk management . 16
42 Annex C (normative) Test for security of attachment of plain end to conical
43 connector . 17
44 Annex D (normative) Test for security of attachment of adaptor to breathing tube . 18
45 Annex E (normative) Test for leakage . 19
46 Annex F (normative) Measurement of resistance to flow . 21
47 Annex G (normative) Test for increase in flow resistance with bending . 24
48 Annex H (normative) Test for compliance . 26
49 Bibliography . 28
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oSIST prEN ISO 5367:2021
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50 Foreword
51 ISO (the International Organization for Standardization) is a worldwide federation of national
52 standards bodies (ISO member bodies). The work of preparing International Standards is normally
53 carried out through ISO technical committees. Each member body interested in a subject for which a
54 technical committee has been established has the right to be represented on that committee.
55 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
56 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
57 matters of electrotechnical standardization.
58 The procedures used to develop this document and those intended for its further maintenance are
59 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
60 different types of ISO documents should be noted. This document was drafted in accordance with the
61 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
62 Attention is drawn to the possibility that some of the elements of this document may be the subject of
63 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
64 any patent rights identified during the development of the document will be in the Introduction and/or
65 on the ISO list of patent declarations received (see www.iso.org/patents).
66 Any trade name used in this document is information given for the convenience of users and does not
67 constitute an endorsement.
68 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
69 expressions related to conformity assessment, as well as information about ISO's adherence to the
70 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
71 URL: www.iso.org/iso/foreword.html.
72 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
73 equipment Subcommittee SC 2, Airways and related equipment.
74 This document is written following the format of ISO 18190 General standard for airways and related
75 equipment. The requirements in this device-specific standard take precedence over any conflicting
76 requirements in the general standard.
77 This sixth edition cancels and replaces the fifth edition (ISO 5367:2014), which has been technically
78 revised.
79 The main changes compared to the previous edition are as follows:
80 the layout now follows the format of ISO 18190:2016 General standard for airways and related
81 equipment;
82
the general requirements such as risk management, usability, clinical investigation and some
83
common marking requirements have been removed as they are now in ISO 18190 and cross-
84
referenced in the appropriate clauses of this document.
85
the list of normative references, many of which are cited in ISO 18190 has been updated.
86 Requirements for hose systems for neonatal applications were added, e.g. the 11.5mm conical
87 connector according to ISO 5356-1 was added
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oSIST prEN ISO 5367:2021
ISO/DIS 5367:2021(E)
88 Introduction
89 This document contains requirements for breathing sets, breathing tubes and connectors that are
90 intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets and
91 breathing tubes are characterized by certain design requirements such as a means of connection and
92 leakage limits. Disclosure requirements for conformance and flow resistance values allow the user to
93 make an informed choice when connecting these accessories to a breathing system. These design
94 requirements are intended to allow operation within the limits of performance of the anaesthetic
95 breathing systems and ventilator breathing systems with which the accessories are intended to operate.
96 This document includes requirements for both single-use and reusable breathing sets and breathing
97 tubes. Re-usable breathing sets and breathing tubes are intended to comply with the requirements of
98 this document for the recommended service life.
99 Certain tests are performed under constant pressure to simplify the test methodology. It is recognized
100 that this does not reflect clinical use, where pressure is intermittent and peak pressures occur for short
101 periods. The limits in the test methods take this into account. While such test methods do not address
102 product variability, the limits required also take this into account.
103 Throughout this document, all pressures are denoted in SI units of hPa with corresponding cmH O
2
104 equivalent values rounded to the nearest whole cmH O.
2
105 NOTE The unit cmH O is not an SI notation and is not used in ISO documents; rounded cmH O values are given for
2 2
106 information only to allow comparison to medical literature and related breathing system standards.
107 Throughout this document the following print types are used:
108 requirements and definitions: roman type;
109 conformance tests: italic type;
110 informative material appearing outside of tables, such as notes, examples and references: smaller type.
111 The normative text of tables is also in smaller type;
112 terms defined in clause 3: italic type.
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oSIST prEN ISO 5367:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 5367:2021(E)
113 Anaesthetic and respiratory equipment – Breathing sets and
114 connectors
115 1 *Scope
116 This document specifies minimum requirements for breathing sets and breathing tubes intended to be
117 used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It
118 applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and
119 to those supplied as components and assembled in accordance with the manufacturer’s instructions.
120 This document is applicable to breathing sets which include special components (e.g. water traps)
121 between the patient end and machine end which are supplied already assembled.
122 Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets
123 and breathing tubes suitable for use with patient end adaptors.
124 NOTE: Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
125 This document is not applicable to breathing sets and breathing tubes for special purposes.
126 EXAMPLE 1: Ventilators having special compliance, pressure or breathing frequency requirements.
127 Requirements for breathing system components such as exhalation valves, exhaust valves, adjustable
128 pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir
129 bags, are not covered by this document but can be found in ISO 80601-2-12, ISO 80601-2-13, ISO 9360-
[3] [4], [1]
130 1 , ISO 23328-2 and ISO 5362 . Requirements for heated breathing tubes can be found in ISO
[2]
131 80601-2-74 .
132 2 *Normative references
133 The following documents are referred to in the text in such a way that some or all of their content
134 constitutes requirements of this document. For dated references, only the edition cited applies. For
135 undated references, the latest edition of the referenced document (including any amendments) applies.
136 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
137 sockets
138 IEC 60601-1:2020, Medical electrical equipment — Part 1: General requirements for basic safety
139 and essential performance
140 ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and
141 related equipment
142 3 Terms and definitions
143 For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
144 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
145 — IEC Electropedia: available at http://www.electropedia.org/
146 — ISO Online browsing platform: available at https://www.iso.org/obp
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147 3.1
148 anaesthetic breathing system
149 inspiratory and expiratory gas pathways through which anaesthetic gas flows at respiratory pressure
150 between the fresh-gas inlet, the connection port (3.9) and an exhaust valve or exhaust port
151 [SOURCE: ISO 80601-2-13:2011, 201.3.203]
152 3.2
153 antistatic
154 property of a material or procedure that disperses or inhibits the accumulation of electrostatic charges
155 3.3
156 APL valve
157 adjustable pressure-limiting valve
158 pressure-limiting valve which releases gas over an adjustable range of pressures
159 [SOURCE: ISO 4135:2001, 4.3.6, modified]
160 3.4
161 assembled end
162 end of a breathing tube (3.7) incorporating an adaptor (3.1)
163 3.5
164 breathing set
165 assembly of breathing tubes, (3.6) connectors and components that form the gas pathways of a
166 breathing system between the ventilator and the patient’s airway device
167 Note 1 to entry: The exhaust valve, APL valves, heat and moisture exchanger (HME), breathing system filter, and
168 reservoir bag are not included.
169 3.6
170 breathing tube
171 non-rigid tube used to convey gases and/or vapours between components of a breathing system
172 [SOURCE: ISO 4135:2001, 4.1.2]
173 3.7
174 compliance
175 volume added per unit pressure increase when gas is added to an enclosed space, expressed at the
176 temperature and humidity of that enclosed space and at ambient atmospheric pressure
177 [SOURCE: ISO 4135:2001, 3.1.5]
178 3.8
179 patient connection port
180 opening intended for connection to an airway device
181 Note to entry: e.g. tracheal or tracheostomy tube, face mask, supralaryngeal airway
182 [SOURCE: ISO 4135:2001, 4.2.1.2, modified]
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183 3.9
184 machine end
185 end of the breathing set (3.5) or breathing tube (3.6) intended to be connected to the anaesthetic
186 workstation, ventilator or other breathing system component furthest from the patient
187 [SOURCE: ISO 4135:2001, 4.2.3.2, modified]
188 3.10
189 patient end
190 end of the breathing set (3.5) or breathing tube (3.6) which is intended to be connected to the patient
191 end adaptor, Y-piece or other appropriate component near the patient
192 3.11
193 patient end adaptor
194 tubular connector with multiple ports, one of which is a patient connection port (3.8)
195 Note 1 to entry: Examples of patient end adaptors include a Y-piece, (3.16) a swivel adaptor, (3.14) and other
196 specialized adaptors (3.1) for coaxial, multiple tubes, and bifurcated tubes. See also Annex A, Figures A.1 to A.5.
197 3.12
198 plain end
199 end of a breathing tube (3. 6) designed to fit directly over a male conical connector complying with ISO
200 5356-1
201 3.13
202 swivel adaptor
203 specialized adaptor (3.1) which allows variation in the position of its ports relative to each other
204 3.14
205 ventilator breathing system
206 VBS
207 inspiratory or expiratory gas pathways through which gas flows at respiratory pressures and bounded
208 by the port through which fresh gas enters, the patient connection port (3.8) and the exhaust port
209 [SOURCE: ISO 80601-2-12:2011, 201.3.221]
210 4 General requirements
211 4.1 General
212 The applicable requirements of ISO 18190:2016, Clause 4 shall apply.
213 NOTE: An informative list of identified hazards is contained in Annex B.
214 4.2 Test methods
215 Manufacturers may use type tests different from those detailed within this document, if an equivalent
216 degree of safety is obtained. However, in the event of dispute, the methods specified herein shall be
217 used as the reference methods.
218 4.3 Recommended service life
219 Re-usable breathing sets and breathing tubes shall comply with the requirements of this document
220 throughout the recommended service life as required in 9.3.4.
221 Check conformance by inspection of the manufacturer’s technical documentation.
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222 5 Materials
223 5.1 General
224 The applicable requirements of ISO 18190:2016, Clause 5 shall apply.
225 5.2 Biological safety testing
226 Breathing sets shall also be evaluated and tested in conformance with ISO 18562-1.
227 Check conformance by inspection of the manufacturer’s technical documentation.
228 6 Design requirements
229 6.1 General
230 The applicable requirements of ISO 18190:2016, Clause 6 shall apply.
231 6.2 Designated length
232 6.2.1 The length of breathing tubes shall be designated by their nominal overall length, expressed in
233 metres, when measured in the resting condition (without extension), lying on a horizontal surface.
234 Breathing tubes intended to be extended when used shall be designated by both the unextended and
235 extended lengths.
236 Check conformance by functional testing.
237 6.2.2 The designated length of breathing tubes provided securely attached to a Y-piece or patient end
238 adaptor shall include the length of the patient end adaptor and any assembled ends.
239 Check conformance by functional testing.
240 6.2.3 The actual length shall be within ± 10 % of the designated length.
241 Check conformance by functional testing.
242 6.3 Means of connection
243 6.3.1 General
244 6.3.1.1 Breathing tubes shall have plain ends complying with 6.3.2 or assembled ends with adaptors
245 incorporating 22 mm, 15 mm or 11,5 mm conical connectors complying with ISO 5356-1.
246 Check conformance by inspection.
247 6.3.2 Plain ends of breathing tubes
248 6.3.2.1 The axial length [l in Figure 1 a)] of the plain ends of breathing tubes, excluding those specified
1
249 in 6.3.2.2, shall be not less than 21 mm for breathing tubes intended to engage with 22 mm male cones
250 or not less than 14 mm for breathing tubes intended to engage with 15 mm male cones compliant with
251 ISO 5356-1 or shall be not less than 10,5 mm for breathing tubes intended to engage with 11,5 mm
252 male conical connectors.
253 Check conformance by functional testing.
254 6.3.2.2 The axial length [l in Figure 1 a)] of the plain ends of breathing tubes that incorporate an
2
255 internal ridge [see Figure 1 b)], intended to engage with the recess at the base of a 22 mm male cone as
256 specified in ISO 5356-1, shall be not less than 26,5 mm.
257 Check conformance by functional testing.
258 6.3.2.3 Plain ends of breathing tubes shall not become detached from a 22 mm or 15 mm ISO 5356-1
259 compliant male cone at a force of less than 40 N or shall not become detached from an 11,5mm ISO
260 5356-1 compliant male cone at a force of less than 25 N.
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261 Check conformance by the test given in Annex C.
262
263 a) b)
264 Figure 1 — Axial length of plain end of breathing tubes
265 6.3.3 Adaptor
266 The end of the adaptor that is not intended for attachment to the breathing tube shall be a 22 mm or 15
267 mm or 11,5 mm socket complying with ISO 5356-1.
268 Check conformance by inspection of the manufacturer’s technical documentation.
269 6.3.4 Assembled end
270 Adaptors shall not detach from the breathing tube at a force of less than
271 a) 45 N for 15 mm and 22 mm adaptors
272 and
273 b) 30 N for 11,5 mm adaptors
274 Adaptors for use in breathing sets or breathing tubes for neonatal ventilation using an 11.5mm ISO
275 5356-1 compliant female cone shall not detach from the breathing tube at a force of less than 30N.
276 NOTE For the purpose of this requirement, a patient end adaptor provided securely attached to a breathing tube is
277 regarded as an adaptor.
278 Check conformance by the test given in Annex D.
279 6.3.5 Patient end adaptors
280 Patient connection ports of patient end adaptors shall be a conical connector complying with ISO 5356-
281 1 and be one of the following:
282 a) a coaxial 22 mm cone/15 mm socket;
283 b) a 15 mm socket;
284 or
285 c) an 11,5 mm socket
286 Check conformance by inspection of the manufacturer’s technical documentation.
287 6.4 Leakage
288 6.4.1 Leakage from breathing tubes shall not exceed 10 ml/min at (60 ± 3) hPa [(60 ± 3) cmH O].
2
289 Check conformance by the test given in Annex E.
290 6.4.3 *Leakage from complete breathing sets shall not exceed the leakage limit listed for the designated
291 patient category in Table 1.
292 Check conformance by the test given in Annex E.
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oSIST prEN ISO 5367:2021
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293 *Table 1 — Leakage limit by patient category
Patient Intended delivered volume Leakage limit At pressure
category
ml/min hPa
(cmH O)
2
Adult ≥ 300 ml 70 60 ± 3
Paediatric 50 ml < 300 ml 40 60 ± 3
Neonatal ≤ 50 ml 30 60 ± 3
NOTE See Annex E.
294 6.5 Resistance to flow
295 6.5.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
296 [see 8.4.1 a)] the resistance to flow per metre length of tubing at the flow listed for the designated
297 patient category in Table 2. The flow resistance shall not exceed the limit in Table 2.
298 Check conformance by the test given in Annex F.
299 *Table 2 — Flow resistance limit per metre by patient category for breathing tubes supplied to be cut to
300 length
Flow resistance limit At flow
Patient category Intended delivered
hPa/l/min l/min
volume
(cmH2O/l/min)
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.
301 6.5.2 *For breathing tubes supplied ready for use or for each limb of a breathing set, the manufacturer
302 shall determine, mark, and disclose [see 9.2 c) and 9.3.1 b)] the resistance to flow at the flow listed for
303 the designated patient category Table 3.
304 If the resistance exceeds the limit listed in Table 3 for the designated patient category, the risk shall be
305 assessed in the risk management file and, if required, marked and disclosed [see 9.2 c) and 9.2.1 b)].
306 Check conformance by the test given in Annex F and, if required, by inspection of the manufacturer’s risk
307 management file.
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308 *Table 3 — Flow resistance limit by patient category for breathing sets and breathing tubes supplied ready
309 for use
Patient category Intended delivered Flow resistance limit At flow
volume hPa/l/min/m l/min
(cmH2O/l/min/m)
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.
310 6.5.3 The increase in flow resistance when breathing tubes are suspended over a metal cylinder shall
311 not exceed 150 % of the value obtained when the tube is straight.
312 Check conformance by the test given in Annex G.
313 6.6 Compliance
314 6.6.1 For breathing tubes supplied to be cut to length, the manufacturer shall determine and disclose
315 [see 9.3.1 d)] the compliance per metre of tubing at the pressure listed for the designated patient
316 category. in Table 4. The compliance per metre of the tubing shall not exceed the limit in Table 4.
317 Check conformance by the test given in Annex H.
318 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/cmH2O/m) (cmH2O)
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.
319 6.6.2 *For breathing sets or breathing tubes supplied ready for use, the manufacturer shall determine
320 mark, and disclose [See 9.2 e) and 9.3.1 e)] the total compliance at the pressure listed for the designated
321 patient category in Table 5.
322 If the compliance exceeds the limit listed in Table 5 for the designated patient category, the risk shall be
323 assessed in the risk management file and, if required, marked and disclosed [See 9.2 e) and 9.3.1 e)].
324 Check conformance by the test given in Annex H and, if required, by inspection of the manufacturer’s risk
325 management file.
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326 Table 5 — Compliance limit by patient category for breathing sets and breathing tubes supplied ready for
327 use
Patient category Intended delivered volume Compliance limit At pressure
hPa
ml/hPa (ml/cmH
...
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