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International
Standard
ISO 17256
First edition
Anaesthetic and respiratory
2024-07
equipment — Respiratory therapy
tubing and connectors
Matériel d'anesthésie et de réanimation respiratoire — Tubulures
pour thérapie respiratoire et raccords
Reference number
© ISO 2024
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ii
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 Test methods and conditions .2
5 Materials . 2
5.1 General .2
5.2 Biological assessment of gas pathways .2
6 Design requirements . 2
6.1 General .2
6.2 Specific design requirements .3
6.3 Inlet connectors .5
6.4 Outlet connectors .6
7 Requirements for respiratory tubing, extension tubing and connectors supplied sterile . 6
8 Packaging. 6
9 Information supplied by the manufacturer . 6
9.1 General .6
9.2 Information supplied by the manufacturer .6
Annex A (informative) Rationale . 7
Annex B (normative) Respiratory therapy equipment tubing connectors. 9
Annex C (informative) Hazard identification for the purposes of risk assessment .11
Bibliography .12
iii
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
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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 document should be noted. This document was drafted in accordance with the editorial rules of the
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This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
Subcommittee SC 2, Airway devices and related equipment.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Respiratory tubing and connectors form the essential conduit between the patient interface and the gas supply
device. The connectors specified in this document have been selected taking into consideration the risks of
misconnection with other medical devices commonly used within the same environment. The requirements
in this document were further developed and are to be circulated to all ISO/TC 121 subcommittees as
recommendations.
Respiratory tubing and connectors are used extensively in healthcare facilities and increasingly in the
home healthcare environment where medically trained personnel are not always in attendance. These
environments have been carefully considered throughout the development of this document.
[1]
This document recognizes the significant use and the inherent safety of the EN 13544-2 specified nipple
as the gas outlet on respiratory gas supply devices and therefore specifies a compatible elastomeric (funnel)
connector as the inlet of the respiratory tubing. This document also recognizes the high risks associated with
misconnection of the previously prescribed elastomeric (funnel) connector at the outlet (patient end) of the
tubing and has therefore specified the new R2 respiratory small-bore connector as the outlet connector if
the respiratory tubing is not integrated with the patient interface device (e.g. face mask, nasal cannula).
The concept of extension tubing, commonly used to provide flexibility of movement for the patient in home-
care environments and hospital environments, such as MRI units, toilets and endoscopy units, has now been
included in this document with particular emphasis on the connectors.
[1]
This document is adapted from EN 13544-2:2009 and has been modified as follows:
— the change of outlet from an elastomeric funnel to an R2 respiratory small-bore connector;
— requirements for extension tubing;
— requirements for respiratory tubing integrated with patient interface devices;
— a requirement to assess the biocompatibility of the materials of the devices that provide a gas pathway
has been added;
— the dimensions of the nipple have been better defined;
— the option to specify a gas-specific threaded connection at the inlet of the respiratory tubing to replace
the elastomeric funnel inlet connector has been made clearer;
— the gas-specific threaded inlet connectors now include gasses other than oxygen and air; and
— a hazard identification annex has been added (Annex C).
v
International Standard ISO 17256:2024(en)
Anaesthetic and respiratory equipment — Respiratory
therapy tubing and connectors
1 Scope
This document specifies requirements for the respiratory tubing and connectors used to convey respirable
gases to a patient in the healthcare and homecare environments and provide a safe connection between the
gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of
oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures
such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for
respiratory therapy extension tubing.
NOTE 1 The gas supply devices referred to in this document do not include anaesthetic machines/workstations and
ventilators.
NOTE 2 This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367.
This document is written following the format of ISO 18190, General standard for airways and related
equipment. The requirements in this device-specific standard take precedence over any conflicting
requirements in the General standard
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 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 21920-1, Geometrical product specifications (GPS) — Surface texture: Profile — Part 1: Indication of
surface texture
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Respiratory small-
bore connectors
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:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
extension tubing
flexible conduit with connectors to extend the connection between the respiratory tubing (3.4) and the
patient interface (3.2)
3.2
patient interface
part connected to the patient
EXAMPLE Mask, nasal cannula or connectors thereof.
3.3
permanently attached
not removable without the use of a tool
Note 1 to entry: There is rationale for this definition in A.2.
3.4
respiratory tubing
flexible conduit with connectors to connect the gas supply device to the patient interface (3.2) or extension
tubing (3.1)
4 General requirements
4.1 General
The requirements of ISO 18190:2016, Clause 4, shall apply.
4.2 Test methods and conditions
The test methods i
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