ISO 5364:2001

INTERNATIONAL ISO
STANDARD 5364
Third edition
2001-09-01
Anaesthetic and respiratory equipment —
Oropharyngeal airways
Matériel d'anesthésie et de réanimation respiratoire — Canules
oropharyngées
Reference number
ISO 5364:2001(E)
© ISO 2001

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ISO 5364:2001(E)
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ISO 5364:2001(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Size designation and dimensions . 2
5 Materials . 3
6 Design . 3
7 Performance requirements . 3
8 Sterility assurance . 4
9 Packaging of oropharyngeal airways supplied sterile . 4
10 Marking . 4
11 Information to be supplied by the manufacturer . 5
Annexes
A Test method for resistance to collapse of the buccal portion. 6
A.1 Principle . 6
A.2 Apparatus . 6
A.3 Test procedure . 6
A.4 Expression of result . 6
B Test method for patency of lumen. 8
B.1 Principle . 8
B.2 Apparatus . 8
B.3 Test procedure . 8
B.4 Expression of results . 8
C Guidance on materials and design . 10
Bibliography. 11
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ISO 5364:2001(E)
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 com-
mittees. 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 liai-
son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 5364 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Tracheal tubes and other equipment.
This third edition cancels and replaces the second edition (ISO 5364:1986), which has been technically revised. This
edition introduces a test for patency of lumen as well as a test for resistance to collapse of the buccal end. Metal air-
ways have been excluded from this scope because of their association with dental trauma.
Annexes A and B form a normative part of this International Standard. Annex C is for information only.
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ISO 5364:2001(E)
Introduction
This International Standard 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 human airway by the soft tissue.
Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasers are
1)
used, is a well-recognized hazard . It is addressed by appropriate clinical management, which is outside the scope
of this International Standard.
1) See ISO/TR 11991.
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INTERNATIONAL STANDARD ISO 5364:2001(E)
Anaesthetic and respiratory equipment — Oropharyngeal airways
1 Scope
This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, in-
cluding those with a reinforcement insert made of plastics materials and/or metal.
This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flam-
mability of oropharyngeal airways.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publica-
tions do not apply. However, parties to agreements based on this International Standard are encouraged to investi-
gate the possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain reg-
isters of currently valid International Standards.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 11607, Packaging for terminally sterilized medical devices
EN 556:1994, Sterilization of medical devices — Requirements for medical devices to be labelled “STERILE”
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
oropharyngeal airway
device intended to maintain a gas pathway through the oral cavity and pharynx
[ISO 4135]
3.2
pharyngeal end
that end of an oropharyngeal airway which is intended to be inserted into a patient's oropharynx
[ISO 4135]
3.3
flanged end
that end of an oropharyngeal airway which is flanged and is intended to be external to the teeth or gums
[ISO 4135]
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ISO 5364:2001(E)
4 Size designation and dimensions
4.1 Size designation
The size of oropharyngeal airways shall be designated by the nominal length (see l, Figure 1) expressed in
centimetres, in accordance with Table 1.
NOTE The manufacturer's own size designa
...