oSIST prEN ISO 17256:2026

SLOVENSKI STANDARD
01-marec-2026
Anestezijska in dihalna oprema - Cevi in priključki za dihalno terapijo (ISO
17256:2024)
Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors (ISO
17256:2024)
Anästhesie- und Beatmungsgeräte - Schläuche und Verbindungsstücke für die
respiratorische Therapie (ISO 17256:2024)
Matériel d'anesthésie et de réanimation respiratoire - Tubulures pour thérapie
respiratoire et raccords (ISO 17256:2024)
Ta slovenski standard je istoveten z: prEN ISO 17256
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.

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 17256:2024(en) © ISO 2024
ISO 17256:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 17256:2024(en)
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
ISO 17256:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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.
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.

iv
ISO 17256:2024(en)
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 tex
...