SIST EN ISO 5364:2011
(Main)Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
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 5364:2008)
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 5364:2008)
L'ISO 5364:2008 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. L'inflammabilité des canules oropharyngées, par exemple en cas d'utilisation de produits anesthésiques, 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.
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO 5364:2008)
Ta mednarodni standard določa zahteve za ustno-žrelne (orofaringalne) dihalne cevke iz plastičnih materialov in/ali gume, vključno s tistimi, katerih vložek za ojačanje je izdelan iz plastičnih materialov in/ali kovine. Ta mednarodni standard ne velja za kovinske ustno-žrelne (orofaringealne) dihalne cevke niti za zahteve, ki zadevajo gorljivost ustno-žrelnih (orofaringealnih) dihalnih cevk. Gorljivost ustno-žrelnih (orofaringealnih) dihalnih cevk, če se na primer uporabijo gorljivi anestetiki, elektrokirurške enote ali laserji, je dobro znana nevarnost. Je predmet kliničnega nadzorovanja, ki je zunaj področja uporabe tega mednarodnega standarda. Ta mednarodni standard ne velja za supralaringealne dihalne cevke brez notranjih vgrajenih tesnilnih mehanizmov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5364:2011
01-julij-2011
1DGRPHãþD
SIST EN 12181:2000
Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO
5364:2008)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
Anästhesie- und Beatmungsgeräte - Oropharyngealtuben (ISO 5364:2008)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO
5364:2008)
Ta slovenski standard je istoveten z: EN ISO 5364:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5364:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5364:2011
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SIST EN ISO 5364:2011
EUROPEAN STANDARD
EN ISO 5364
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Oropharyngeal airways
(ISO 5364:2008)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Oropharyngealtuben
Canules oropharyngées (ISO 5364:2008) (ISO 5364:2008)
This European Standard was approved by CEN on 24 March 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5364:2011: E
worldwide for CEN national Members.
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SIST EN ISO 5364:2011
EN ISO 5364:2011 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 5364:2011
EN ISO 5364:2011 (E)
Foreword
The text of ISO 5364:2008 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 5364:2011 by 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
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.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 5364:2008 has been approved by CEN as a EN ISO 5364:2011 without any modification.
3
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SIST EN ISO 5364:2011
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SIST EN ISO 5364:2011
INTERNATIONAL ISO
STANDARD 5364
Fourth edition
2008-07-15
Corrected version
2009-01-15
Anaesthetic and respiratory equipment —
Oropharyngeal airways
Matériel d'anesthésie et de réanimation respiratoire — Canules
oropharyngées
Reference number
ISO 5364:2008(E)
©
ISO 2008
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SIST EN ISO 5364:2011
ISO 5364:2008(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2008
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from 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
Published in Switzerland
©
ii ISO 2008 – All rights reserved
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SIST EN ISO 5364:2011
ISO 5364:2008(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
Annex A (normative) Test method for resistance to collapse of the buccal portion . 6
Annex B (normative) Test method for patency of lumen . 8
Annex C (informative) Guidance on materials and design . 10
Bibliography . 11
©
ISO 2008 – All rights reserved iii
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SIST EN ISO 5364:2011
ISO 5364:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO5364 was prepared by Technical Committee ISO/TC121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This fourth edition cancels and replaces the third edition (ISO 5364:2001), which has been technically revised.
In this corrected version of ISO 5364:2008 Figure 1 has been replaced with an illustration in which the position
given in key 3 is corrected.
©
iv ISO 2008 – All rights reserved
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SIST EN ISO 5364:2011
ISO 5364:2008(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 airway by the soft tissues.
©
ISO 2008 – All rights reserved v
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SIST EN ISO 5364:2011
.
vi
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SIST EN ISO 5364:2011
INTERNATIONAL STANDARD ISO 5364:2008(E)
Anaesthetic and respiratory equipment — Oropharyngeal
airways
1Scope
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
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijska in dihalna oprema - Ustno-žrelne (orofaringealne) dihalne cevke (ISO 5364:2008)Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO 5364:2008)Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 5364kSIST FprEN ISO 5364:2010en01-november-2010kSIST FprEN ISO 5364:2010SLOVENSKI
STANDARD
kSIST FprEN ISO 5364:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 5364
September 2010 ICS 11.040.10 English Version
Anaesthetic and respiratory equipment -Oropharyngeal airways (ISO 5364:2008)
Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées (ISO 5364:2008)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 5364:2010: EkSIST FprEN ISO 5364:2010
FprEN ISO 5364:2010 (E) 2 Contents Page Foreword .3 kSIST FprEN ISO 5364:2010
FprEN ISO 5364:2010 (E) 3 Foreword The text of ISO 5364:2008 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 5364:2010 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This document is currently submitted to the Unique Acceptance Procedure. Endorsement notice The text of ISO 5364:2008 has been approved by CEN as a FprEN ISO 5364:2010 without any modification.
kSIST FprEN ISO 5364:2010
kSIST FprEN ISO 5364:2010
INTERNATIONALSTANDARDISO5364Fourth edition2008-07-15Reference numberISO5364:2008(E)© ISO2008Corrected version2009-01-15Anaesthetic and respiratory equipment— Oropharyngeal airwaysMatériel d'anesthésie et de réanimation respiratoire— Canules oropharyngées
kSIST FprEN ISO 5364:2010
ISO5364:2008(E)ii© ISO2008–All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shallnot be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. Indownloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariataccepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creationparameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In theunlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT©ISO2008All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel.+ 41 22 749 01 11Fax+ 41 22 749 09 47E-mailcopyright@iso.orgWebwww.iso.orgPublished in SwitzerlandkSIST FprEN ISO 5364:2010
ISO5364:2008(E)© ISO2008–All rights reservediiiContents Page1Scope . 12Normative references . 13Terms and definitions . 14Size designation and dimensions . 25Materials . 36Design . 37Performance requirements . 38Sterility assurance . 49Packaging of oropharyngeal airways supplied sterile . 410Marking . 411Information to be supplied by the manufacturer . 5AnnexA(normative)Test method for resistance to collapse of the buccal portion . 6AnnexB(normative)Test method for patency of lumen . 8AnnexC(informative)Guidance on materials and design . 10Bibliography . 11kSIST FprEN ISO 5364:2010
ISO5364:2008(E)iv© ISO2008–All rights reservedForewordISO (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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational 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 document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO5364 was prepared by Technical Committee ISO/TC121, Anaesthetic and respiratory equipment,Subcommittee SC2, Tracheal tubes and other equipment.This fourth edition cancels and replaces the third edition (ISO5364:2001), which has been technically revised.In this corrected version of ISO5364:2008 Figure1 has been replaced with an illustration in which the positiongiven in key3 is corrected.kSIST FprEN ISO 5364:2010
ISO5364:2008(E)© ISO2008–All rights reservedvIntroductionThis 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 forwardthe base of the tongue to prevent obstruction of the airway by the soft tissues.kSIST FprEN ISO 5364:2010
.vikSIST FprEN ISO 5364:2010
INTERNATIONAL STANDARDISO5364:2008(E)© ISO2008–All rights reserved1Anaesthetic and respiratory equipment— Oropharyngeal airways1ScopeThis International Standard specifies requirements for oropharyngeal airways of plastics materials and/orrubber, 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 concerningflammability of oropharyngeal airways.Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasersare used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside thescope of this International Standard.This International Standard is not applicable to supralaryngeal airways without an internal, integral sealingmechanism.2Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO7000, Graphical symbols for use on equipment— Index and synopsisISO10993-1, Biological evaluation of medical devices— Part1: E
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