SIST EN ISO 5364:2026

Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2026)

This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).

Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO 5364:2026)

Dieses Dokument legt Anforderungen an Oropharyngealtuben fest.
Dieses Dokument ist nicht anwendbar für Oropharyngealtuben aus Metall und enthält keine Anforderungen an die Entflammbarkeit von Oropharyngealtuben.
Dieses Dokument gilt nicht für Supralaryngealtuben, die durch ISO 11712 [1] abgedeckt sind.
Die Anforderungen, die auch für andere Atemwegsvorrichtungen gelten, wurden aus diesem Dokument entfernt, da sie nun in der allgemeinen Norm für Atemwegsvorrichtungen und zugehörige Geräte (ISO 18190) enthalten sind.
Die Anforderungen in dieser gerätespezifischen Norm haben Vorrang vor jedweden gegenteiligen Anforderungen in der allgemeinen Norm für Atemwegsvorrichtungen und zugehörige Geräte (ISO 18190).

Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO 5364:2026)

Le présent document spécifie les exigences relatives aux canules oropharyngées.
Le présent document ne s'applique pas aux canules oropharyngées en métal, et ne traite pas des exigences concernant l'inflammabilité des canules oropharyngées.
Il ne s'applique pas aux canules supralaryngées, qui sont couvertes par l'ISO 11712[1].
Les exigences qui s'appliquent également à d'autres canules ont été supprimées du présent document car elles figurent désormais dans la norme générale relative aux canules (ISO 18190).
Les exigences qui figurent dans cette norme spécifique au dispositif prévalent sur toute exigence contradictoire de la norme générale relative aux canules (ISO 18190).

Anestetična in respiratorna oprema - Orofaringealni zračni kanali (ISO 5364:2026)

Ta dokument določa zahteve za orofaringealne dihalne poti.
Ta dokument ni uporaben za kovinske orofaringealne dihalne poti, niti za zahteve, ki se nanašajo na vnetljivost orofaringealnih dihalnih poti.
Ta dokument ni uporaben za supralaryngealne dihalne poti, ki so zajete v ISO 11712[1].
Zahteve, ki so prav tako uporabne za druge naprave za dihalne poti, so bile odstranjene iz tega dokumenta, saj so zdaj vključene v splošni standard za naprave za dihalne poti (ISO 18190).
Zahteve v tem standardu, specifičnem za naprave, imajo prednost pred kakršnimi koli nasprotujočimi si zahtevami v splošnem standardu za naprave za dihalne poti (ISO 18190).

General Information

• Status: Published
• Public Enquiry End Date: 30-Oct-2025
• Publication Date: 29-Jun-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Jun-2026
• Due Date: 16-Aug-2026
• Completion Date: 30-Jun-2026
• Ref Project: EN ISO 5364:2026 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2026)

Relations

• Replaces: SIST EN ISO 5364:2016 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
• Effective Date: 01-Jul-2026

Overview

SIST EN ISO 5364:2026 specifies the requirements for oropharyngeal airways used in anaesthetic and respiratory equipment. These essential medical devices are designed to maintain an open airway by holding the tongue away from the posterior pharyngeal wall during anaesthesia and emergency interventions. The standard ensures the safety, quality, and performance of oropharyngeal airways, excluding devices made from metal and excluding flammability requirements. It does not apply to supralaryngeal airways, which are addressed in ISO 11712, nor does it duplicate requirements now covered in the general airway device standard, ISO 18190.

This international standard, developed by the Technical Committee ISO/TC 121 and adopted as a Slovenian national standard (SIST), plays a crucial role for manufacturers, healthcare providers, and regulatory bodies concerned with respiratory and resuscitation equipment.

Key Topics

• Scope and Exclusions

  • Applies to non-metal, reusable or disposable oropharyngeal airways
  • Excludes metal airways and flammability considerations
  • Not applicable to supralaryngeal airway devices

• Terminology

  • Defines key anatomical and component terms: oropharyngeal airway, pharyngeal end, flanged end

• Materials and Construction

  • Requirements for materials that resist deterioration from anaesthetic gases, cleaning, disinfection, and sterilization
  • Design must minimize risk of dental and soft tissue trauma
  • Reinforcement inserts, if used, must be securely attached and corrosion-resistant

• Design and Size Specification

  • Size indicated by nominal length (in cm), corresponding to patient anatomy
  • Dimensions and tolerances specified for each size
  • Inside lumen dimension must allow passage of suction catheters

• Marking and Colour Coding

  • Marked with size, manufacturer’s name or trademark, indication of latex if present
  • Colour coding by size for rapid identification in clinical emergencies

• Performance and Safety Tests

  • Resistance to collapse under compression at elevated temperature
  • Lumen patency under simulated clinical use conditions

• Packaging and Information

  • Shelf and multi-unit packs must be clearly labelled with size and relevant information for safe selection and use

Applications

Oropharyngeal airways standardized by SIST EN ISO 5364:2026 are vital in:

• Hospitals and surgical suites for general anaesthesia
• Emergency departments for airway management
• Pre-hospital and ambulance care settings
• Intensive care, resuscitation, and critical care units

The standard provides assurance of device safety and functionality, minimizing risk for patients and aiding clinicians in rapid, accurate device selection. Adherence to ISO 5364:2026 simplifies procurement, supports compliance with international regulations, and promotes harmonization of respiratory and anaesthetic equipment worldwide.

Related Standards

For comprehensive airway device regulation and compatibility, consider these closely associated standards:

• ISO 18190: Anaesthetic and respiratory equipment - General requirements for airways and related equipment
• ISO 11712: Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
• ISO 4135: Anaesthetic and respiratory equipment - Vocabulary
• ISO/TR 11991: Guidance on airway management during laser surgery of the upper airway

Summary

SIST EN ISO 5364:2026 elevates patient safety and clinical effectiveness in airway management by setting rigorous and harmonized requirements for oropharyngeal airways. Its provisions enable healthcare professionals and manufacturers to achieve high standards of quality, reliability, and interoperability for anaesthetic and respiratory devices in varied medical environments. For any organization seeking to market or use oropharyngeal airways, compliance with this standard signifies a commitment to the highest levels of patient care and product excellence.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 5364:2016
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO
5364:2026)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2026)
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO 5364:2026)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO
5364:2026)
Ta slovenski standard je istoveten z: EN ISO 5364:2026
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 5364
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2026
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5364:2016
English Version
Anaesthetic and respiratory equipment - Oropharyngeal
airways (ISO 5364:2026)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Canules oropharyngées (ISO 5364:2026) Oropharyngealtuben (ISO 5364:2026)
This European Standard was approved by CEN on 25 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 5364:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 5364:2026) 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 December 2026, and conflicting national standards
shall be withdrawn at the latest by December 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.
This document supersedes EN ISO 5364:2016.
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 5364:2026 has been approved by CEN as EN ISO 5364:2026 without any modification.

International
Standard
ISO 5364
Sixth edition
Anaesthetic and respiratory
2026-05
equipment — Oropharyngeal
airways
Matériel d'anesthésie et de réanimation respiratoire — Canules
oropharyngées
Reference number
ISO 5364:2026(en) © ISO 2026
ISO 5364:2026(en)
© ISO 2026
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 5364:2026(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 Safety.2
5 Materials . 2
5.1 General .2
5.2 Material requirements.2
6 Design requirements . 2
6.1 General .2
6.2 Size designation .2
6.3 Dimensions .4
7 Cleaning disinfection and sterilization . 4
8 Information to be supplied by the manufacturer . 5
8.1 General .5
8.2 Marking .5
8.3 Marking of shelf or multi-unit packs .6
Annex A (informative) Rationale . 7
Annex B (normative) Test method for resistance to collapse of the buccal portion . 9
Annex C (normative) Test method for patency of lumen .11
Annex D (informative) Guidance on materials and design .13
Bibliography . 14

iii
ISO 5364:2026(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, 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 5364:2016), which has been technically revised.
The main changes are as follows:
— this document has been rewritten to follow the format of ISO 18190;
— the temperature of testing the lumen of the buccal portion and patency has changed from 34 °C to 40 °C
to reflect the ambient conditions that can be reached in emergency use in some countries.
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 5364:2026(en)
Introduction
This document specifies dimensions and other requirements for oropharyngeal airways.
Airway size is designated by length, which is important when selecting an oropharyngeal airway to hold
forward the base of the tongue to prevent obstruction of the airway by the soft tissues.
Airway size is indicated by a legible marking and by a colour code, which are important to allow rapid
identification and selection in emergencies.
NOTE The terms defined in Clause 3 are denoted throughout the document in italic font.

v
International Standard ISO 5364:2026(en)
Anaesthetic and
...