oSIST prEN ISO 5364:2025

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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Reference number
ISO/DIS 5364:2025(en)
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
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BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 5364:2025(en)
ii
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

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

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.

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.

ISO/DIS 5364:2025(en)
115 Anaesthetic and respiratory equipment —
116 Oropharyngeal airways
117 1 Scope
...