SIST EN ISO 5364:2016

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

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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
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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.
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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
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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
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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.
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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
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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
...