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).

Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO 5364:2026)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Oct-2025
• 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
• 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
oSIST prEN ISO 5364:2025
01-oktober-2025
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke
(ISO/DIS 5364:2025)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO/DIS 5364:2025)
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO/DIS 5364:2025)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO/DIS
5364:2025)
Ta slovenski standard je istoveten z: prEN ISO 5364
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5364:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 5364:2025
oSIST prEN ISO 5364:2025
DRAFT
International
Standard
ISO/DIS 5364
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Oropharyngeal
Voting begins on:
airways
2025-08-12
Matériel d'anesthésie et de réanimation respiratoire — Canules
Voting terminates on:
oropharyngées
2025-11-04
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 5364:2025(en)
oSIST prEN ISO 5364:2025
DRAFT
ISO/DIS 5364:2025(en)
International
Standard
ISO/DIS 5364
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Oropharyngeal
Voting begins on:
airways
Matériel d'anesthésie et de réanimation respiratoire — Canules
Voting terminates on:
oropharyngées
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 5364:2025(en)
ii
oSIST prEN ISO 5364:2025
ISO/DIS 5364:2025(en)
22 Contents
23 Foreword . 5
24 Introduction. 6
25 1 Scope . 7
26 2 Normative references . 7
27 3 Terms and definitions . 7
28 4 General requirements . 8
29 4.1 General . 8
30 4.2 Safety . 8
31 5 Materials . 8
32 5.1 General . 8
33 5.2 Material requirements . 8
34 6 Design requirements . 8
35 6.1 General . 8
36 6.2 Size designation . 8
37 Figure 1 — Examples of oropharyngeal airways and their component parts. 9
38 Table 1 — Size designation of oropharyngeal airways — Dimensions and tolerances . 10
39 6.3 Dimensions . 10
40 7 Cleaning disinfection and sterilization . 11
41 8 Information to be supplied by the manufacturer . 11
42 8.1 General . 11
43 8.2 Marking . 11
44 Figure 2 — Typical marking locations on flanged end of oropharyngeal airways . 11
45 Table 2 — Oropharyngeal airway colour code . 11
46 8.3 Marking of shelf or multi-unit packs . 12
47 Annex A (informative) Rationale . 13
48 Table A.1 — Size colour code identified in a survey of 13 airway manufacturers . 14
49 Table A.2 — Size colour code selected for this document . 14
50 Annex B (normative) Test method for resistance to collapse of the buccal portion . 15
51 B.1 Principle . 15
52 B.2 Apparatus . 15

oSIST prEN ISO 5364:2025
ISO/DIS 5364:2025(en)
53 B.3 Test procedure . 15
54 B.4 Expression of result . 15
55 Figure B.1 — Apparatus for testing resistance to collapse of the buccal portion . 16
56 Annex C (normative) Test method for patency of lumen . 17
57 C.1 Principle . 17
58 C.2 Apparatus . 17
59 C.3 Test procedure . 17
60 Figure C.1 — Apparatus for testing patency of lumen . 18
61 Annex D (informative) Guidance on materials and design . 19
62 Bibliography . 20

oSIST prEN ISO 5364:2025
ISO/DIS 5364:2025(en)
63 Foreword
64 ISO (the International Organization for Standardization) is a worldwide federation of national standards
65 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
66 through ISO technical committees. Each member body interested in a subject for which a technical
67 committee has been established has the right to be represented on that committee. International
68 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
69 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
70 electrotechnical standardization.
72 The procedures used to develop this document and those intended for its further maintenance are
73 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
74 different types of ISO document should be noted. This document was drafted in accordance with the
75 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
77 ISO draws attention to the possibility that the implementation of this document may involve the use of
78 (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
79 patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice
80 of (a) patent(s) which may be required to implement this document. However, implementers are
81 cautioned that this may not represent the latest information, which may be obtained from the patent
82 database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
83 such patent rights.
85 Any trade name used in this document is information given for the convenience of users and does not
86 constitute an endorsement.
88 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
89 expressions related to conformity assessment, as well as information about ISO's adherence to the World
90 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
91 www.iso.org/iso/foreword.html.
93 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
94 Subcommittee SC 2, Airway devices and related equipment, in collaboration with the European Committee
95 for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
96 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
98 This sixth edition cancels and replaces the fifth edition (ISO 5364:2016), which has been technically
99 revised.
101 The main changes are as follows:
102 — this document has been rewritten to follow the format of ISO 18190.
103 — the temperature of testing the lumen of the buccal portion and patency has changed from 34°C to
104 50°C to reflect the ambient conditions that can be reached in emergency use in some countries.
106 Any feedback or questions on this document should be directed to the user’s national standards body. A
107 complete listing of these bodies can be found at www.iso.org/members.html.

oSIST prEN ISO 5364:2025
ISO/DIS 5364:2025(en)
108 Introduction
109 This document specifies dimensions and other requirements for oropharyngeal airways.
110 Airway size is designated by length, which is important when selecting an oropharyngeal airway to hold
111 forward the base of the tongue to prevent obstruction of the airway by the soft tissues.
112 Airway size is indicated by a legible marking and by a colour code, which are important to allow rapid
113 identification and selection in emergencies.
114 NOTE The terms defined in Clause 3 are denoted throughout the document in italic font.

oSIST prEN ISO 5364:2025
ISO/DIS 5364:2025(en)
115 Anaesthetic and respiratory equipment —
116 Oropharyngeal airways
117 1 Scope
118 This document specifies requirements for oropharyngeal airways.
119 This document is not applicable to metal oropharyngeal airways, nor to requirements concerning
120 flammability of oropharyngeal airways.
...