INTERNATIONAL ISO

STANDARD 23368

First edition
2022-07

Anaesthetic and respiratory

equipment — Low-flow nasal cannulae
for oxygen therapy
Matériel d'anesthésie et d'assistance respiratoire — Canules nasales à
faible débit pour oxygénothérapie

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ISO 23368:2022
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23368-2022

Reference number
ISO 23368:2022(E)

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ISO 23368:2022(E)

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23368-2022

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© ISO 2022
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 ISO 23368:2022(E)

Contents Page

Foreword......................................................................................................................................................................................................................................... iv
Introduction..................................................................................................................................................................................................................................v
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 General requirements..................................................................................................................................................................................... 2
5 Materials........................................................................................................................................................................................................................ 2
5.1 General............................................................................................................................................................................................................ 2
5.2 Biological safety of gas pathways........................................................................................................................................... 2
6 Design requirements........................................................................................................................................................................................ 2
6.1 General............................................................................................................................................................................................................ 2
6.2 Resistance to flow................................................................................................................................................................................. 4
6.3 Inlet connectors...................................................................................................................................................................................... 5
6.4 Nasal prongs.............................................................................................................................................................................................. 6
7 Sterility........................................................................................................................................................................................................................... 7
8 Packaging..................................................................................................................................................................................................................... 7
9
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Information supplied by the manufacturer............................................................................................................................. 7
Annex A (normative) Test method for resistance to flow.............................................................................................................. 8
(standards.iteh.ai)
Annex B (normative) Test methods for security of connectors and nasal prongs ............................................... 9

ISO 23368:2022
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ISO 23368:2022(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
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/
iso/foreword.html.
(standards.iteh.ai)
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airways and related equipment, in collaboration with the European
Committee for Standardization (CEN) Technical ISOCommittee
23368:2022CEN/TC 215, Respiratory and anaesthetic
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equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement). 23368-2022
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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 ISO 23368:2022(E)

Introduction
Low-flow nasal cannulae are used to guide oxygen directly to the patient’s nasal passageways via nasal
prongs during the administration of oxygen therapy.
Several countries have introduced a fire-activated oxygen flow-stopping device for use with oxygen
therapy systems especially in the home-care environment that prevents the proliferation of fire along
the tubing if it catches light. It is recommended that these flow-stopping devices be fitted as close to the
patient as possible.

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23368-2022
INTERNATIONAL STANDARD ISO 23368:2022(E)

Anaesthetic and respiratory equipment — Low-flow nasal

cannulae for oxygen therapy

1 Scope
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital
environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but
does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.

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 and semantics

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ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility(standards.iteh.ai)
evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 80369-2,1)Small-bore connectors for ISO
liquids and gases in healthcare applications — Part 2: Connectors
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respiratory applications
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 18190 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://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
3.1
inlet connector
connection on the low-flow nasal cannula (3.3) that connects to the outlet of the oxygen supply device or
the outlet of the therapy tubing
3.2
integral nasal cannula
low-flow nasal cannula (3.3) and therapy tubing with no user-detachable connectors between the inlet
connector (3.1) and the nasal prongs
3.3
low-flow nasal cannula
patient interface designed for use with flows ≤6 l/min for the administration of oxygen via nasal prongs

1) Under preparation. Stage at time of publication ISO/DIS 80369-2:2022.

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ISO 23368:2022(E)

3.4
oxygen therapy
supplemental oxygen administered to a patient at atmospheric pressure
3.5
user-detachable nasal cannula
low-flow nasal cannula (3.3) with connections between the inlet connector (3.1) and the nasal prongs
that can be detached by the user

4 General requirements
The requirements of ISO 18190:2016, Clause 4, shall apply.

5 Materials

5.1 General
The requirements of ISO 18190:2016, Clause 5, shall apply.

5.2 Biological safety of gas pathways

Gas pathways of low-flow nasal cannulae shall be assessed for biological safety according to ISO 18562-1.
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Check conformance by inspection of the technical file.

6 Design requirements (standards.iteh.ai)

6.1 General ISO 23368:2022
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6.1.1 The requirements of ISO 18190:2016, Clause23368-2022
6, shall apply.

6.1.2 Low-flow nasal cannulae shall either be:

a) an integral part of the therapy tubing with a minimum length of 1,8 m (see Figure 1); or
b) user-detachable from the therapy tubing with an inlet connector within 100 mm of the bifurcation,
(see Figure 2) or if not bifurcated within 500 mm of the nasal prongs.
Check conformance by inspection.

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 ISO 23368:2022(E)

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Key
1 nasal prongs 23368-2022 4 bifurcation/wye connector
2 headset tubing/headset loop 5 therapy tubing
3 toggle/slide/slide bolo (adjuster) 6 inlet connector

Figure 1 — Example of integral nasal cannula

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ISO 23368:2022(E)

Key
1 nasal prongs 3 toggle/slide/slide bolo (adjuster)
2 headset tubing/headset loop 4 R2 respiratory small-bore socket connector

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Figure 2 — Example of user-detachable nasal cannula

6.1.3 (standards.iteh.ai)
A low-flow nasal cannula shall operate normally, i.e. within its specification, at flows ≤15 l/min.

Check conformance by inspection of the technical file.

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6.2 Resistance to flow
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6.2.1 The resistance to flow of the therapy tubing shall not exceed 0,9 kPa/m at a flow of 4 l/min for
adult sizes, 3 l/min for paediatric sizes and 2 l/min for neonatal sizes.

Check conformance by the test given in Annex A.

6.2.2 The resistance to flow of the headset shall not exceed 10 kPa at a flow of 4 l/min for adult sizes,
3 l/min for paediatric sizes and 2 l/min for neonatal sizes.
NOTE The resistance to flow through headsets is based on testing of devices on the market. It is higher than
that for therapy tubing as headset tubing can be markedly smaller particularly if it bifurcates. This is not seen as
detrimental to patients as they receive oxygen from both tubes.

Check conformance by the test given in Annex A.

6.2.3 Flow shall not reduce by more than 25 % when the therapy tubing of the low-flow nasal cannula
is bent in a semicircle of diameter three times its smallest outside diameter at flows of 4 l/min for adult
sizes, 3 l/min for paediatric sizes and 2 l/min for neonatal sizes.

Check conformance by the test given in Annex A.

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