SIST EN ISO 5364:2016
(Main)Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
This International Standard specifies requirements for oropharyngeal airways of plastics materials
and/or rubber, including 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 flammability of oropharyngeal airways.
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.
This International Standard is not applicable to supralaryngeal airways without an internal, integral
sealing mechanism.
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO 5364:2016)
Diese Internationale Norm legt Anforderungen an Oropharyngealtuben aus Kunststoff und/oder Gummi, mit oder ohne Verstärkungseinsatz aus Kunststoff und/oder Metall, fest.
Diese Internationale Norm gilt nicht für Oropharyngealtuben aus Metall und enthält keine Anforderungen an die Entflammbarkeit von Oropharyngealtuben.
Die Entflammbarkeit von Oropharyngealtuben, z. B. bei Anwendung von entflammbaren Anästhesiemitteln, elektrochirurgischen Geräten oder Laser, stellt eine bekannte Gefährdung dar. Sie wird durch entsprechendes klinisches Management berücksichtigt, das jedoch nicht Gegenstand dieser Internationalen Norm ist.
Diese Internationale Norm gilt nicht für supralaryngeale Atemwege ohne einen internen, integrierten Abdichtmechanismus.
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO 5364:2016)
ISO 5364:2016 spécifie les exigences relatives aux canules oropharyngées en matière plastique et/ou en caoutchouc, notamment celles qui comportent un renfort inséré en matière plastique et/ou en métal.
ISO 5364:2016 ne s'applique pas aux canules oropharyngées en métal, ni ne traite des exigences concernant l'inflammabilité des canules oropharyngées.
L'inflammabilité des canules oropharyngées, par exemple en cas d'utilisation de produits anesthésiques inflammables, d'appareils d'électrochirurgie ou de lasers, représente un danger bien connu. Ce problème est pris en compte par une gestion clinique appropriée, qui ne relève pas du domaine d'application de la présente Norme internationale.
ISO 5364:2016 ne s'applique pas aux canules supralaryngées ne comportant pas de mécanisme d'obturation intégré.
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO 5364:2016)
Ta mednarodni standard določa zahteve za orofaringealne dihalne cevke iz plastičnih materialov
in/ali gume, vključno s tistimi z vstavki za ojačanje iz plastičnih materialov in/ali kovine.
Ta mednarodni standard se ne uporablja za kovinske orofaringealne dihalne cevke in za zahteve
glede vnetljivosti orofaringealnih dihalnih cevk.
Vnetljivost orofaringealnih dihalnih cevk, na primer pri uporabi vnetljivih anestetikov, elektrokirurških enot ali laserjev, je dobro poznana nevarnost. Preprečuje se z ustreznim kliničnim upravljanjem, ki ne spada na področje uporabe tega mednarodnega standarda.
Ta mednarodni standard se ne uporablja za supralaringealne dihalne cevke brez notranjega celostnega tesnilnega mehanizma.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5364:2016
01-december-2016
1DGRPHãþD
SIST EN ISO 5364:2011
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO
5364:2016)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO 5364:2016)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO
5364:2016)
Ta slovenski standard je istoveten z: EN ISO 5364:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5364:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5364:2016
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SIST EN ISO 5364:2016
EN ISO 5364
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5364:2011
English Version
Anaesthetic and respiratory equipment - Oropharyngeal
airways (ISO 5364:2016)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Canules oropharyngées (ISO 5364:2016) Oropharyngealtuben (ISO 5364:2016)
This European Standard was approved by CEN on 15 July 2016.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5364:2016 E
worldwide for CEN national Members.
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 5
2
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
European foreword
This document (EN ISO 5364:2016) 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 March 2017, and conflicting national standards shall
be withdrawn at the latest by September 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 5364:2011.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes ZZ.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 4135 EN ISO 4135:2001 ISO 4135:2001
ISO 7000 — ISO 7000:2014
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 11607-1 EN ISO 11607-1:2009 + ISO 11607-1:2006 + AMD
A1:2014 1:2014
1 1
ISO 15223-1 EN 15223-1:— ISO 15223-1:2015
3
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
EN 556-1:2001 EN 556-1:2001 —
1 The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more
information, consult http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
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, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 5364:2016 has been approved by CEN as EN ISO 5364:2016 without any modification.
4
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] / [M/295 concerning
the development of European Standards related to medical devices] / [reference number and title of
any other standardization request as relevant] to provide one voluntary means of conforming to
essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ
L 160].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.1 (second indent) 5 Partly covered. There are no
10.3.1 c) requirements for materials
apart from a requirement to
10.4 C)
indicate the presence of
natural rubber (latex), if
applicable.
8.1 8 Covered on for packaging of
9.1 sterile devices.
9.2
9.2
8.3 9.3 Partly addressed by 9.3 which
mandates the requirements of
ISO 11607-1 that the
5
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
packaging is suitable to
prevent contamination during
transportation and use.
8.7 9.1 Partly covered. Marked sterile
if appropriate
9.2 (first two indents) 4 Partly covered to address only
6 the risk of injury in connection
7 with their physical features by
specifying sizing and marking
conventions for the length and
ID of the airway and by testing
for collapse and patency.
12.7.1 6 Partly covered with a
requirement to limit sharp
edges.
13.1 9
10
11
13.2 10.3.3 Covered only for the use of
10.3.4 identification colours.
13.3 b) 10.3.1 a)
10.3.3
10.5 a)
10.5 b)
13.3 c) 10.4 a)
10.5 e)
13.3 d) 10.5 d) To cover this ER fully, the
batch number must be
preceded by the word ‘LOT’.
13.3 e) 10.5 f) To cover this ER fully, the
‘strong’ recommendation to
state the use by date is
mandatory.
13.3 f) 10.4 b) Only the first sentence is
10.5 f) covered.
13.3 k) 10.3.1 c) Limited to indications only of
10.4 b) single use and the presence of
natural rubber (latex).
10.4 c)
10.5 f)
13.3 m) 10.5 e) To cover th is ER fully, the
recommendation to provide
the method of sterilisation is
mandatory (if applicable).
13.6 h) (firs paragraph only) 11.1
6
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SIST EN ISO 5364:2016
EN ISO 5364:2016 (E)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
7
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SIST EN ISO 5364:2016
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SIST EN ISO 5364:2016
INTERNATIONAL ISO
STANDARD 5364
Fifth edition
2016-09-01
Anaesthetic and respiratory
equipment — Oropharyngeal airways
Matériel d’anesthésie et de réanimation respiratoire — Canules
oropharyngées
Reference number
ISO 5364:2016(E)
©
ISO 2016
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SIST EN ISO 5364:2016
ISO 5364:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 5364:2016
ISO 5364:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Size designation and dimensions . 2
4.1 Size designation . 2
4.2 Dimensions . 3
5 Materials . 3
6 Design . 3
7 Performance requirements . 3
7.1 Resistance to collapse of the buccal portion . 3
7.2 Patency of lumen . 3
8 Sterility assurance . 4
9 Packaging of oropharyngeal airways supplied sterile . 4
10 Marking . 4
10.1 General . 4
10.2 Use of symbols . 4
10.3 Marking of oropharyngeal airways . 4
10.4 Marking of unit packs . 5
10.5 Marking of shelf or multi-unit packs . 6
11 Information to be supplied by the manufacturer . 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
© ISO 2016 – All rights reserved iii
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SIST EN ISO 5364:2016
ISO 5364:2016(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 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 documents should
...
SLOVENSKI STANDARD
oSIST prEN ISO 5364:2014
01-julij-2014
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke
(ISO/DIS 5364:2014)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO/DIS 5364:2014)
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO/DIS 5364:2014)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO/DIS
5364:2014)
Ta slovenski standard je istoveten z: prEN ISO 5364 rev
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5364:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5364:2014
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oSIST prEN ISO 5364:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5364
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-03-27 2014-08-27
Anaesthetic and respiratory equipment — Oropharyngeal
airways
Matériel d’anesthésie et de réanimation respiratoire — Canules oropharyngées
[Revision of fourth edition (ISO 5364:2008)]
ICS: 11.040.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5364:2014(E)
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. ISO 2014
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oSIST prEN ISO 5364:2014
ISO/DIS 5364:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
16 Contents Page
17 Foreword . iv
18 Introduction . v
19 1 Scope . 1
20 2 Normative references . 1
21 3 Terms and definitions . 1
22 4 Size designation and dimensions . 2
23 5 Materials . 3
24 6 Design . 3
25 7 Performance requirements . 3
26 8 Sterility assurance . 4
27 9 Packaging of oropharyngeal airways supplied sterile . 4
28 10 Marking . 4
29 11 Information to be supplied by the manufacturer . 6
30 Annex A (informative) Rationale . 7
31 Annex B (normative) Test method for resistance to collapse of the buccal portion . 9
32 Annex C (normative) Test method for patency of lumen . 11
33 Annex D (informative) Guidance on materials and design . 13
34 Bibliography . 14
35 Annex ZA (informative) Relationship between this European Standard and the Essential
36 Requirements of EU Directive 93/42/EEC . 15
© ISO 2013 – All rights reserved iii
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
37 Foreword
38 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
39 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
40 technical committees. Each member body interested in a subject for which a technical committee has been
41 established has the right to be represented on that committee. International organizations, governmental and
42 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
43 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
44 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
45 The main task of technical committees is to prepare International Standards. Draft International Standards
46 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
47 International Standard requires approval by at least 75 % of the member bodies casting a vote.
48 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
49 rights. ISO shall not be held responsible for identifying any or all such patent rights.
50 ISO 5364 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
51 Subcommittee SC 2, Airways and related equipment.
52 This fifth edition cancels and replaces the fourth edition (ISO 5364:2008), which has been technically revised.
53 Throughout this International Standard, text for which rationale is provided in Annex A is indicated by an
54 asterisk (*).
55 Major changes in this edition include a new legibility test methods and requirements, and a colour code to
56 indicate designated size.
57 Major changes in this International Standard are highlighted in a BLUE box during the Enquiry phase only.
58 These highlights will be removed during the approval and publication phases.
iv © ISO 2013 – All rights reserved
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
59 Introduction
60 This International Standard specifies dimensions and other requirements for oropharyngeal airways.
61 Airway size is designated by length, which is important when selecting an oropharyngeal airway to hold
62 forward the base of the tongue to prevent obstruction of the airway by the soft tissues.
63 Airway size is indicated by a legible marking and by a colour code, which are important to allow rapid
64 identification and selection in emergencies.
© ISO 2013 – All rights reserved v
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oSIST prEN ISO 5364:2014
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oSIST prEN ISO 5364:2014
DRAFT INTERNATIONAL STANDARD ISO/DIS 5364
Anaesthetic and respiratory equipment — Oropharyngeal
airways
1 Scope
This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or
rubber, including 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
flammability of oropharyngeal airways.
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.
This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing
mechanism.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to
be supplied – Part 1: General requirements
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
oropharyngeal airway
device intended to maintain a gas pathway through the oral cavity and pharynx
© ISO 2013 – All rights reserved
1
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
[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]
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 designation may additionally be given, but this is not recommended.
1 buccal portion
2 reinforcement insert, if provided
3 position for measuring minimum inside dimension (see )
4 flanged end
For see 4.1 and 4.2.1.
Figure 1 — Dimensions for size designation of oropharyngeal airways
© ISO 2013 – All rights reserved
2
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
Table 1 — Size designation of oropharyngeal airways — Dimensions and tolerances
Designated size
Length and tolerance Minimum inside dimension
(nominal length)
cm
mm mm
3
30 2,5 2,5
3,5
3,0
35 2,5
4 3,0
40 2,5
4,5 3,0
45 2,5
5
50 2,5 3,5
5,5
55 2,5 3,5
6
4,0
60 2,5
6,5 4,0
65 2,5
+5,0
7
4,0
70
-2,5
8
80 5,0 4,5
9
90 5,0 4,5
10
5,0
100 5,0
11 5,5
110 5,0
12
120 5,0 5,5
4.2 Dimensions
4.2.1 The length (see l, Figure 1) shall be in accordance with Table 1.
4.2.2 The minimum inside dimension at any point along the length of the airway shall be not less than that
specified in Table 1.
NOTE This dimension is relevant to the ability to pass other devices, e.g. a suction catheter, through the airway.
5 Materials
Oropharyngeal airways, in their ready-for-use state after any preparation for use recommended by the
manufacturer, shall satisfy appropriate biological safety testing, as indicated in ISO 10993-1.
6 Design
Edges and corners intended to come into contact with the patients tissues shall have a minimum radius of
curvature of 0,5 mm.
7 Performance requirements
7.1 Resistance to collapse of the buccal portion
When tested in accordance with Annex B, the minimum inside dimension of the buccal portion of the airway
shall be not less than 75% of that given in Table 1 for the size of the airway being tested.
7.2 Patency of lumen
When tested in accordance with Annex C, the patency of the oropharyngeal airway lumen shall be maintained.
© ISO 2013 – All rights reserved
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oSIST prEN ISO 5364:2014
ISO/DIS 5364
8 Sterility assurance
Oropharyngeal airways supplied and marked “STERILE” shall satisfy the requirements of 4.1 of EN 556-
1:2001.
9 Packaging of oropharyngeal airways supplied sterile
9.1 Each oropharyngeal airway supplied and marked “STERILE” shall be contained in an individual pack.
9.2 The pack shall serve as an effective barrier to the penetration of micro-organisms and particulate material
in accordance with ISO 11607-1.
9.3 The pack shall permit the aseptic extraction of the contents and shall not be capable of re-closure without
clearly revealing that it has been opened.
9.4 The designated size of the airway shall be apparent on visual examination of the intact unit container.
9.5 Individual packs shall be contained within a shelf or multi-unit pack.
10 Marking
10.1 General
Marking of oropharyngeal airways, of unit packs and of shelf or multi-unit packs and information to be supplied
by the manufacturer should comply with EN 1041.
10.2 Use of symbols
The requirem
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