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EN ISO 5361:2012

(Main)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)

same as ISO 5361

Anästhesie­ und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2012)

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   Sie werden durch ISO/TR 11991, ISO 11990 1, ISO 11990 2 und ISO 14408 abgedeckt [1] [2] [3] [4].

Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2012)

Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO 5361:2012)

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 rameni, konusni sapnični tubusi in sapnični tubusi s sredstvi za sesanje, nadzorovanje ali dostavo 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. Trahiobronhialni (endobronhialni) tubusi, traheotomični tubusi in supralaringealne zračne poti so izključene iz 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

Status
Withdrawn
Publication Date
30-Sep-2012
Withdrawal Date
27-Sep-2016
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
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 5361:2013 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)

Relations

Replaces
EN 1782:1998+A1:2009 - Tracheal tubes and connectors
Effective Date
12-Dec-2012
Replaced By
EN ISO 5361:2016 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Effective Date
08-Jun-2022
Corrected By
EN ISO 5361:2012/AC:2012 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012)
Effective Date
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5361:2013
01-januar-2013
1DGRPHãþD
SIST EN 1782:2000+A1:2009
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2012)
Ta slovenski standard je istoveten z: EN ISO 5361:2012
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5361:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5361:2013

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SIST EN ISO 5361:2013


EUROPEAN STANDARD
EN ISO 5361

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Tracheal tubes and
connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2012) Verbindungsstücke (ISO 5361:2012)
This European Standard was approved by CEN on 15 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5361:2012: E
worldwide for CEN national Members.

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 5361:2013
EN ISO 5361:2012 (E)
Foreword
This document (EN ISO 5361:2012) 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 April 2013, and conflicting national standards shall be withdrawn at the
latest by October 2015.
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 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 5361:2012 has been approved by CEN as a EN ISO 5361:2012 without any modificatio
...

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This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, 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.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1      There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.

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