SIST 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
• 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)

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

SIST EN ISO 5364:2026 is the Slovenian national standard adopting ISO 5364:2026 for anaesthetic and respiratory equipment - oropharyngeal airways. It specifies the requirements for the device, including materials, dimensions, test methods, marking, and manufacturer information, for people who design, make, test, buy, or select these airways.

What does SIST EN ISO 5364:2026 specify?

SIST EN ISO 5364:2026 specifies requirements for oropharyngeal airways and sets out how to identify, design, test, and mark them. It also explains how this device-specific standard works with ISO 18190, which covers the general requirements for airway devices.

The document is not for metal oropharyngeal airways, and it does not cover flammability requirements. It is also not for supralaryngeal airways, which are covered by ISO 11712. Requirements that apply across airway devices have been moved to ISO 18190, while the requirements in this document take precedence if there is any conflict.

The document is organized into eight clauses and four annexes:

Annex	What it covers
Annex A	Rationale for the main requirements
Annex B	Test method for resistance to collapse of the buccal portion
Annex C	Test method for patency of lumen
Annex D	Guidance on materials and design

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

SIST EN ISO 5364:2026 combines general airway-device requirements from ISO 18190 with device-specific requirements for shape, strength, marking, and identification. In practice, it tells the manufacturer what must be checked on the product itself and what must be documented in the risk management file.

Safety and materials

Clause 4 requires the general requirements of ISO 18190:2025, Clause 4, and says the airway shall minimize the risk of dental and soft tissue trauma. For a manufacturer, this means the design must protect the mouth and tissues during insertion and use, and the risk management file is part of the evidence used to show conformity.

Clause 5 requires the general material rules of ISO 18190:2025, Clause 5, and adds two material expectations. The material shall resist deterioration from anaesthetic gases and volatile agents, and reusable devices shall also resist foreseeable cleaning, disinfection, and sterilization methods. That matters because the airway must keep its function and safety characteristics during normal clinical use and, if reusable, after reprocessing.

Size designation and dimensions

Clause 6 defines the size of an oropharyngeal airway by its nominal length in centimetres. Table 1 links each designated size to its dimensions, so users can select the right airway by size rather than by appearance alone.

The airway length shall match Table 1, and the inside dimension along the length shall not fall below the specified minimum at any point. This is important in practice because the airway must remain open enough for airflow and for passage of other devices such as a suction catheter.

Edges and corners that may touch patient tissues shall have a minimum radius of curvature of 0.5 mm. That reduces the chance of local tissue injury, especially during insertion and handling.

Resistance to collapse and lumen patency

Clause 6 also sets two performance checks for the buccal portion and the lumen. The buccal portion shall keep at least 75% of the inside dimension when tested at 40 °C under the specified force, and the test force depends on the designated size. Annex B gives the test method, so laboratories know how to condition the airway, apply the load, and measure the compressed dimension.

The lumen shall not reduce in patency by more than 25% when tested at 40 °C under a 5 N force. Annex C gives the test method, which uses clamping and a steel ball to verify that the lumen still allows passage. In practice, these tests check that the airway will not collapse or close off when it is in use.

If the manufacturer claims a wider temperature range, that wider range must also be tested. This matters when a product is intended for more demanding or unusual environments.

Reinforcement inserts and reprocessing

If reinforcement inserts are used, they shall be securely attached and not detachable without a tool, and they shall meet the material requirements of Clause 5. That prevents loose parts and keeps the insert covered by the same material durability expectations as the rest of the airway.

Clause 7 requires the cleaning, disinfection, and sterilization requirements of ISO 18190:2025, Clause 7. For reusable products, this links the airway’s design and materials to the reprocessing methods it is intended to withstand.

Marking and pack information

Clause 8 requires the general information rules of ISO 18190:2025, Clause 8, and adds device-specific marking. The flanged end shall show the designated size, the manufacturer and/or supplier name or trademark, and an indication if natural rubber (latex) is present.

The airway shall also be colour coded by size, and the colour code shall be visible from the flanged end. That helps staff identify the right size quickly, which is important in emergency and time-sensitive situations. Shelf or multi-unit packs shall also be marked with the designated size.

What terms does SIST EN ISO 5364:2026 define?

SIST EN ISO 5364:2026 uses a small set of terms that matter for size, orientation, and use.

• 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 the flange that remains external to the teeth or gums.
• designated size - the size identification used in the standard, based on nominal length in centimetres.
• nominal length - the length used to designate the size of the airway.
• buccal portion - the part of the airway that is compressed in the collapse test and clamped in the patency test.
• natural rubber (latex) - the material whose presence must be indicated on the device if it is present.

Who uses SIST EN ISO 5364:2026?

SIST EN ISO 5364:2026 is used by manufacturers and suppliers of oropharyngeal airways, because it tells them how to design the product, choose materials, mark it, and prove performance. It is also used by test laboratories and quality or regulatory teams that need to run the collapse and patency tests in Annexes B and C.

It is relevant to buyers, clinical procurement staff, and anaesthesia or emergency-care users who need to select the correct size quickly and understand the marking and colour code. Because the document focuses on anaesthetic and respiratory equipment, it is most relevant where airway management products are specified, checked, or purchased.

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

SIST EN ISO 5364:2026 replaces SIST EN ISO 5364:2016 and the fifth edition of ISO 5364. The main changes stated in the document are that the standard has been rewritten to follow the format of ISO 18190, and the test temperature for the lumen of the buccal portion and for 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 SIST EN ISO 5364:2026?

SIST EN ISO 5364:2026 uses ISO 18190:2025 as its normative reference for the general requirements for airway devices and related equipment. Clauses 4, 5, 6, 7, and 8 of ISO 18190 are called up throughout this document, so it provides the shared baseline that this airway-specific standard builds on.

ISO 11712 is named in the scope as the standard covering supralaryngeal airways. ISO 4135:2022 is the source of the definitions used for the terms and definitions in Clause 3.

What does the SIST EN ISO 5364:2026 document contain?

SIST EN ISO 5364:2026 contains the core technical material needed to specify and check an oropharyngeal airway. Table 1 sets the size designation, nominal length, and dimensional tolerances, while Figure 1 shows the airway parts used to interpret those dimensions.

The marking requirements in Clause 8 are illustrated by Figure 2, and Table 2 assigns the size-based colour code. Annex A explains the rationale, including the colour-code background, and Annex D gives guidance on materials and design choices. Annexes B and C provide the test setups, apparatus, and procedures used for collapse resistance and lumen patency verification, which are the main laboratory checks in the document.

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
...