EN ISO 5364:2011
(Main)Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008)
ISO 5364:2008 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. 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.
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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .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
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.
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
ISO 5364:2008(E)
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©
ii ISO 2008 – All rights reserved
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
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
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
.
vi
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 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— Part1: 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
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 980, Graphical symbols for use in the labelling of 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 4135]
©
ISO 2008 – All rights reserved 1
ISO 5364:2008(E)
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.
Key
1 buccal portion
2 reinforcement insert, if provided
3 position for measuring minimum inside dimension (see Table 1)
4 flanged end
a
For l see 4.1 and 4.2.1.
Figure 1 — Dimensions for size designation of oropharyngeal airways
©
2 ISO 2008 – All rights reserved
ISO 5364:2008(E)
Table 1 — Size designation of oropharyngeal airways — Dimensions and tolerances
Designated size Minimum inside
Length and tolerance
(nominal length) dimension
cm mm mm
3230± 2,5,5
3,5 35± 2,5 3,0
4340± 2,5,0
4,5 45± 2,5 3,0
5350± 2,5,5
5,5 55± 2,5 3,5
6460± 2,5,0
6,5 65± 2,5 4,0
+5,0
7470 ,0
−2,5
8480± 5,0,5
9490± 5,0,5
10 100± 5,0 5,0
11 110± 5,0 5,5
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,
...
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