EN ISO 5361:2016
(Main)Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.
Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.
Anästhesie und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2016)
Diese Internationale Norm enthält die grundlegenden Leistungs- und Sicherheitsanforderungen an Orotracheal- und Nasotrachealtuben und an Verbindungsstücke für Trachealtuben. Trachealtuben mit durch Metall oder Nylon verstärkter Wand, Trachealtuben mit Schultern, konische Trachealtuben, Trachealtuben mit Möglichkeiten zum Absaugen, zum Überwachen oder zur Zufuhr von Medikamenten oder sonstigen Gasen und die zahlreichen anderen Arten von Trachealtuben für Spezialanwendungen wurden in diese Internationale Norm aufgenommen, da zahlreiche Spezial-Trachealtuben heutzutage häufig verwendet werden und für alle ähnliche grundlegende Anforderungen entsprechend dieser Internationalen Norm gelten.
Tracheobronchialtuben (Endobronchialtuben), Tracheostomietuben und supralaryngeale Atemwege sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen.
Trachealtuben, die für die Anwendung mit brennbaren Anästhesiegasen oder -mitteln sowie Laser oder elektrochirurgischen Geräten bestimmt sind, sind nicht durch diese Internationale Norm abgedeckt.
ANMERKUNG Die Verweisungen [1] bis [4] decken diese Internationale Norm ab.
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2016)
ISO 5361:2016 fournit les exigences essentielles de performance et de sécurité pour les sondes orotrachéales et nasotrachéales et les raccords de sonde trachéale. Les sondes trachéales à parois renforcées de métal ou de nylon, les sondes trachéales à épaulements, les sondes trachéales coniques, les sondes trachéales avec dispositifs pour aspiration, surveillance ou administration de médicaments ou d'autres gaz ainsi que les nombreux autres types de sondes trachéales conçus pour des applications spéciales sont inclus dans la présente Norme internationale, car de nombreuses sondes trachéales de spécialité sont maintenant d'usage courant et elles partagent toutes des exigences essentielles similaires à celles définies dans l'ISO 5361:2016.
Les sondes endobronchiques (trachéo-bronchiques), les canules de trachéotomie et les canules supralaryngiennes sont exclues du domaine d'application de l'ISO 5361:2016.
Les sondes trachéales destinées à être utilisées avec des gaz ou des agents anesthésiques inflammables, des équipements laser ou du matériel électrochirurgical ne relèvent pas du domaine d'application de l'ISO 5361:2016.
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO 5361:2016)
Ta mednarodni standard določa bistvene zahteve za učinkovitost in varnost ustnih ter nosnih sapničnih (endotrahealnih) tubusov in priključkov. V ta mednarodni standard so vključeni sapnični tubusi, ki imajo stene ojačane s kovino ali najlonom, sapnični tubusi z izboklinami, konusni sapnični tubusi in sapnični tubusi s sredstvi za sesanje, nadzorovanje ali dovajanje zdravil ali drugih plinov. Vključene so tudi druge vrste sapničnih tubusov za posebno uporabo, ker je trenutno v splošni uporabi veliko specializiranih sapničnih tubusov, pri čemer si vsi delijo podobne bistvene zahteve, ki so podane v tem mednarodnem standardu.
Endobronhialni (vključno s traheobronhialnimi) tubusi, traheostomski tubusi in supralaringealne dihalne cevke so izključene s področja uporabe tega mednarodnega standarda.
Sapnični tubusi, ki so namenjeni uporabi z vnetljivimi anestetičnimi plini ali anestetiki, ter laserska ali elektrokirurška oprema ne spadajo na področje uporabe tega mednarodnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5361:2016
01-december-2016
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SIST EN ISO 5361:2013
SIST EN ISO 5361:2013/AC:2013
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Anästhesieund Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO
5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2016)
Ta slovenski standard je istoveten z: EN ISO 5361:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5361:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5361:2016
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SIST EN ISO 5361:2016
EN ISO 5361
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5361:2012
English Version
Anaesthetic and respiratory equipment - Tracheal tubes
and connectors (ISO 5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2016) Verbindungsstücke (ISO 5361:2016)
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 5361:2016 E
worldwide for CEN national Members.
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SIST EN ISO 5361:2016
EN ISO 5361:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] . 5
2
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SIST EN ISO 5361:2016
EN ISO 5361:2016 (E)
European foreword
This document (EN ISO 5361:2016) 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 5361:2012.
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 re
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