SIST EN ISO 17256:2026

Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors (ISO 17256:2024)

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

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)

Le présent document spécifie les exigences relatives aux tubulures respiratoires et aux raccords utilisés pour acheminer des gaz respirables vers un patient dans des environnements de soins et de soins à domicile et pour assurer un raccordement sûr entre le dispositif d'administration de gaz et l'interface patient. Les tubulures respiratoires et les raccords sont principalement utilisés pour l'administration d'oxygène, mais ils peuvent également être utilisés pour l'administration d'air respirable ou de mélanges oxygène/air et de mélanges de gaz médicinaux respirables tels que les mélanges oxygène/protoxyde d'azote ou oxygène/hélium. Le présent document spécifie également les exigences relatives aux tubulures de rallonge pour thérapie respiratoire.
NOTE 1        Les dispositifs d'administration de gaz mentionnés dans le présent document n'incluent pas les appareils/stations de travail d'anesthésie et les ventilateurs.
NOTE 2        Le présent document ne traite pas des tuyaux respiratoires pour les systèmes respiratoires. Ceux-ci sont spécifiés dans l'ISO 5367.
Le présent document est rédigé en respectant le format de l'ISO 18190, Exigences générales pour canules et équipement connexe. Les exigences de cette norme spécifique d'un dispositif prévalent sur toute exigence en contradiction spécifiée dans la norme générale.

Anestezijska in dihalna oprema - Cevi in priključki za dihalno terapijo (ISO 17256:2024)

Ta dokument določa zahteve za dihalne cevi in priključke, ki se uporabljajo za prenos dihalnih plinov do pacienta v zdravstvenem in domačem okolju ter zagotavljajo varno povezavo med napravo za dovod plina in pacientovim vmesnikom. Dihalne cevi in priključki se večinoma uporabljajo za dovajanje kisika, lahko pa se uporabljajo tudi za dihalni zrak ali mešanice kisika/zraka ter dihalne zdravilne plinske mešanice, kot so mešanice kisika/dušikovega oksida ali kisika/helija. Ta dokument prav tako določa zahteve za podaljške dihalne terapije.
OPOMBA 1 Naprave za dovod plina, navedene v tem dokumentu, ne vključujejo anestezijskih aparatov/delovnih postaj in ventilatorjev.
OPOMBA 2 Ta dokument ne zajema dihalnih cevi za dihalne sisteme. Te so določene v ISO 5367.
Ta dokument je napisan po formatu ISO 18190, Splošni standard za dihalne poti in sorodno opremo. Zahteve v tem specifičnem standardu za naprave imajo prednost pred kakršnimi koli nasprotujočimi zahtevami v Splošnem standardu.

General Information

• Status: Published
• Public Enquiry End Date: 30-Mar-2026
• Publication Date: 20-May-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-May-2026
• Due Date: 20-Jul-2026
• Completion Date: 21-May-2026
• Ref Project: EN ISO 17256:2026 - Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors (ISO 17256:2024)

Overview

SIST EN ISO 17256:2026 establishes comprehensive requirements for respiratory therapy tubing and connectors used in both healthcare and homecare environments. Developed by ISO Technical Committee 121 and adopted as a European standard, this document ensures safe, standardized delivery of respirable gases such as oxygen, air, oxygen/air mixtures, and various medicinal gas combinations to patients. The primary objective is to facilitate secure connections between gas supply devices and patient interfaces, enhancing safety and interoperability while minimizing the risk of incorrect connections.

This standard specifically addresses respiratory tubing and connectors but excludes devices such as anesthetic workstations, ventilators, and breathing tubes intended for breathing systems as covered by ISO 5367.

Key Topics

• Scope and Purpose: Focuses on respiratory therapy tubing and connectors designed to convey medical gases safely to patients in diverse care settings.
• Design and Safety Requirements:
  • Tubing and connectors must be robust, capable of withstanding specified axial forces and pressure without detachment or fracture.
  • Connectors must be permanently attached to prevent accidental removal and misconnections.
• Compatibility: Ensures that connectors are compatible with commonly used gas-specific outlets and patient interfaces, reducing the risk of misconnections with other medical devices.
• Performance Criteria:
  • Maximum allowable flow resistance and leak rates.
  • Flexibility of extension tubing for effective use in both clinical and homecare environments.
• Biocompatibility: Materials must comply with relevant biological safety standards, safeguarding patients from exposure to harmful substances.
• Packaging and Labelling: Mandates clear manufacturer information and warnings, especially when devices are recommended for use with fire-activated shut-off valves.

Applications

Respiratory therapy tubing and connectors compliant with SIST EN ISO 17256:2026 are critical in various medical settings, including:

• Hospitals and Clinics: Ensuring error-free and secure delivery of oxygen and medical gas mixtures during respiratory therapy, emergency care, and routine treatments.
• Homecare Environments: Supporting long-term oxygen therapy and portable gas delivery in non-clinical settings where trained medical personnel may not always be present.
• Special Use Cases: Providing flexibility and safety in facilities such as MRI units, endoscopy suites, and patient transport, where extended tubing may be required.
• Patient Safety: Minimizing risks associated with misconnection, blockages, or leaks, which could compromise patient care.

By standardizing connector types and the performance of tubing systems, this standard enhances interoperability across devices from different manufacturers and boosts patient safety throughout the gas supply chain.

Related Standards

SIST EN ISO 17256:2026 references and aligns with several key international standards:

• ISO 18190: General requirements for airways and related anaesthetic and respiratory equipment.
• ISO 80369-2: Small-bore connectors for liquids and gases in healthcare applications, addressing respiratory small-bore connectors to prevent misconnections.
• ISO 5367: Specifies requirements for breathing tubes used in respiratory systems, not covered by this standard.
• ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in healthcare.
• ISO 20417: Information to be supplied by medical device manufacturers.

Compliance with these standards ensures broader compatibility, patient safety, and regulatory adherence, supporting the delivery of high-quality respiratory care in medical and home environments.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-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: EN ISO 17256:2026
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.

EN ISO 17256
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2026
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Respiratory
therapy tubing and connectors (ISO 17256:2024)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Schläuche und
Tubulures pour thérapie respiratoire et raccords (ISO Verbindungsstücke für die respiratorische Therapie
17256:2024) (ISO 17256:2024)
This European Standard was approved by CEN on 3 May 2026.

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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17256:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 17256:2024 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 17256:2026 by 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 November 2026, and conflicting national standards
shall be withdrawn at the latest by November 2026.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
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 17256:2024 has been approved by CEN as EN ISO 17256:2026 without any modification.

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
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: [phone]
Email: [e-mail]
Website: www.iso.org
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
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