Anaesthetic and respiratory equipment — Oropharyngeal airways

Matériel d'anesthésie et de réanimation respiratoire — Canules oropharyngées

General Information

Status
Withdrawn
Publication Date
19-Sep-2001
Withdrawal Date
19-Sep-2001
Current Stage
9599 - Withdrawal of International Standard
Start Date
02-Jul-2008
Completion Date
02-Jul-2008
Ref Project

RELATIONS

Effective Date
15-Apr-2008

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ISO 5364:2001 - Anaesthetic and respiratory equipment -- Oropharyngeal airways
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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 2001

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ii ISO 2001 – All rights reserved
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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

ISO 2001 – All rights reserved iii
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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.

iv ISO 2001 – All rights reserved
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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

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.
ISO 2001 – All rights reserved v
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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]
ISO 2001 – All rights reserved 1
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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
...

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