EN ISO 5364:2026

• Abstract:

  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).

• Status: Published
• Publication Date: 02-Jun-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jun-2026
• Completion Date: 03-Jun-2026
• Ref Project: SIST EN ISO 5364:2026 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2026)

• Replaces: EN ISO 5364:2016 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
• Effective Date: 09-Jun-2024
• Refers: ISO 18190:2025 - Anaesthetic and respiratory equipment — General requirements for airway devices and related equipment
• Effective Date: 09-Sep-2026
• Consolidated By: ISO 5364:2026 - Anaesthetic and respiratory equipment — Oropharyngeal airways
• Effective Date: 12-Feb-2026

EN ISO 5364:2026 is a CEN European Standard for anaesthetic and respiratory equipment that specifies requirements for oropharyngeal airways. It covers the device’s dimensions, materials, marking, colour coding, and test methods for collapse resistance and lumen patency, so manufacturers, test labs, and buyers can identify and verify compliant devices. CEN approved the text of ISO 5364:2026 without modification.

What does EN ISO 5364:2026 specify?

EN ISO 5364:2026 specifies requirements for oropharyngeal airways and how to check the main design and performance features that matter in use. It is not applicable to metal oropharyngeal airways, to flammability requirements, or to supralaryngeal airways, which are covered by ISO 11712.

EN ISO 5364:2026 is organized into clauses on scope, normative references, terms and definitions, general requirements, materials, design requirements, cleaning/disinfection/sterilization, and manufacturer information. It also includes four annexes that separate the rationale, the two test methods, and design guidance.

Annex	What it covers
Annex A	Rationale for the main requirements, including colour coding
Annex B	Normative test method for resistance to collapse of the buccal portion
Annex C	Normative test method for patency of lumen
Annex D	Guidance on materials and design

The document also states that requirements common to other airway devices are now in ISO 18190, and that the device-specific requirements in EN ISO 5364:2026 take precedence where they conflict with ISO 18190.

What are the key requirements of EN ISO 5364:2026?

EN ISO 5364:2026 focuses on safe sizing, suitable materials, shape retention, lumen patency, and clear identification. In practice, these are the points that affect whether the airway fits, stays open, and can be selected quickly in an emergency.

General safety and materials

Clause 4 requires the general requirements of ISO 18190:2025 and adds a specific safety aim: the oropharyngeal airway shall minimize the risk of dental and soft tissue trauma. Clause 5 also brings in ISO 18190:2025 and requires the material to resist deterioration from anaesthetic gases and volatile agents, and - if the device is reusable - from foreseeable cleaning, disinfection, and sterilization methods. For a manufacturer, this means the chosen material has to match the intended clinical environment and reprocessing route.

Size designation and dimensions

Clause 6.2 requires the size to be designated by the nominal length in centimetres, and Table 1 links that length to each designated size and inside dimension. Clause 6.3 then requires the length to match Table 1 and the inside dimension to be at least the stated minimum at any point along the airway. This matters because the airway must be long enough to position correctly and wide enough to allow passage of other devices such as a suction catheter.

Clause 6.3.3 requires edges and corners that may contact patient tissue to have a minimum radius of curvature of 0.5 mm. That reduces the chance of local tissue injury from sharp or abrupt transitions.

Resistance to collapse and lumen patency

Clause 6.3.4 requires the buccal portion to retain at least 75% of the inside dimension under test at 40 °C, using a force that depends on the designated size. Annex B gives the test method for this collapse resistance. In practice, this checks that the airway does not flatten in use and block the gas pathway.

Clause 6.3.5 requires the lumen patency to reduce by no more than 25% under test at 40 °C and with a 50 N force, and Annex C gives the test method. This is important because the lumen has to remain open enough for suction or other clinical passage.

Reinforcement inserts

Clause 6.3.6 requires reinforcement inserts, if used, to be securely attached so they cannot be removed without a tool, and to meet the material requirements of Clause 5. That means a reinforcement feature cannot become a loose part or introduce a different material problem.

Cleaning, marking, and colour coding

Clause 7 applies the cleaning, disinfection, and sterilization requirements of ISO 18190:2025. Clause 8 requires the manufacturer’s information to include marking at the flanged end with the designated size, the manufacturer’s and/or supplier’s name or trademark, and an indication of natural rubber (latex) if present. For users, this supports fast identification and helps with allergy-related handling.

Clause 8.2.2 requires size colour coding, and Clause 8.2.3 requires the colour code to be visible from the flanged end. Annex A explains that colour coding is intended to help rapid size selection and reduce confusion in emergencies. Shelf or multi-unit packs also have to be marked with the designated size.

What terms does EN ISO 5364:2026 define?

EN ISO 5364:2026 defines three core terms that are central to sizing and marking the device.

• Oropharyngeal airway - a device intended to maintain a gas pathway through the oral cavity and pharynx.
• Pharyngeal end - the end intended to be inserted into the patient’s oropharynx.
• Flanged end - the end with a flange that remains outside the teeth or gums.

The document also uses nominal length as the basis for size designation, meaning the size is identified by a stated length in centimetres rather than by an arbitrary product name. It uses buccal portion for the part compressed in the collapse test, and lumen for the internal passage that must remain patent.

Who uses EN ISO 5364:2026?

EN ISO 5364:2026 is used by manufacturers of oropharyngeal airways, testing and inspection laboratories, quality and regulatory teams, and hospital procurement staff. It is also relevant to clinical users who need to choose the right size quickly and to check that the size marking and colour code are clear.

For manufacturers, the document sets the design, materials, and marking baseline for product development. For laboratories, it gives the two normative tests used to verify collapse resistance and lumen patency. For buyers and clinical users, it helps compare products by size designation, colour code, and whether the device is intended to meet the standard’s safety and identification requirements.

What changed in EN ISO 5364:2026 from the previous edition?

EN ISO 5364:2026 supersedes EN ISO 5364:2016. The ISO foreword states that this sixth edition cancels and replaces ISO 5364:2016 and that it has been technically revised.

The stated changes are that the document has been rewritten to follow the format of ISO 18190, and the test temperature for the lumen of the buccal portion and patency has changed from 34 °C to 40 °C to reflect ambient conditions that can occur in emergency use in some countries.

Which standards are used with EN ISO 5364:2026?

EN ISO 5364:2026 refers to several other standards that supply general requirements, exclusions, or definitions.

• ISO 18190:2025 - provides the general requirements for airway devices and related equipment; Clause 4, Clause 5, Clause 6, Clause 7, and Clause 8 of EN ISO 5364:2026 rely on it.
• ISO 11712 - covers supralaryngeal airways, which are outside the scope of EN ISO 5364:2026.
• ISO 4135:2022 - provides the source definitions for the terms used in Clause 3.

What does the EN ISO 5364:2026 document contain?

EN ISO 5364:2026 contains the full framework for specifying and checking oropharyngeal airways, including one sizing figure, one main size-and-dimension table, a colour-code table, and two normative test methods. It also includes informative annexes that explain the rationale for colour coding and provide guidance on materials and design.

Annex B gives the apparatus and procedure for measuring resistance to collapse of the buccal portion, including conditioning at 40 °C and the force applied for different sizes. Annex C gives the apparatus and procedure for checking lumen patency with a steel ball while the airway is loaded. Annex D gives practical guidance on materials and design, including smooth surfaces, corrosion resistance for inserts, and resistance to common clinical agents.

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
...