EN ISO 5364:2016

Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.
ISO 5364:2016 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.
ISO 5364:2016 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 Lasern, 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

• Status: Published
• Publication Date: 27-Sep-2016
• Withdrawal Date: 29-Sep-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 28-Sep-2016
• Completion Date: 28-Sep-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 5364:2016 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)

Relations

• Replaces: EN ISO 5364:2011 - Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
• Effective Date: 30-Sep-2016

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.
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