EN ISO 5366-1:2009

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

2019-02-19 - JO - TC decision 17/2018  (BT N 11332 - BT C160/2018)  to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.

Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)

Dieser Teil von ISO 5366 gilt für Tracheotomietuben aus Kunststoffen und/oder Gummi mit einem Innendurchmesser
von mindestens 6,5 mm. Solche Tuben sind hauptsächlich für Patienten bestimmt, die eine
Anästhesie, künstliche Beatmung oder Atemunterstützung benötigen, ohne jedoch auf diese Anwendungsbereiche
beschränkt zu sein.
Dieser Teil von ISO 5366 gilt nicht für Spezialtuben. Entzündbarkeit von Tracheotomietuben ist nicht Gegenstand
von diesem Teil von ISO 5366.

Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie - Partie 1: Tubes et raccords pour adultes (ISO 5366-1:2000)

L'ISO 5366-1:2000 fixe les prescriptions relatives aux tubes de trachéostomie en plastique et/ou en caoutchouc dont le diamètre intérieur est égal ou supérieur à 6,5 mm. L'usage de ces tubes est essentiellement réservé aux patients dont l'état nécessite une anesthésie, une respiration artificielle ou toute autre aide respiratoire, mais cet usage n'est pas restrictif.
L'ISO 5366-1:2000 ne s'applique pas aux tubes spéciaux et ne traite pas de l'inflammabilité des tubes de trachéostomie.

Anestezijska in dihalna oprema - Traheostomske cevke - 1. del: Cevke in priključki za odrasle (ISO 5366-1:2000)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 25-Oct-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: 26-Oct-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 5366-1:2009 - Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

Relations

• Replaces: EN ISO 5366-1:2004 - Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
• Effective Date: 15-Apr-2009
• Replaced By: EN ISO 5366:2016 - Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
• Effective Date: 16-Jan-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5366-1:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 5366-1:2005
$QHVWH]LMVNDLQGLKDOQDRSUHPD7UDKHRVWRPVNHFHYNHGHO&HYNHLQSULNOMXþNL
]DRGUDVOH,62
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and
connectors for use in adults (ISO 5366-1:2000)
Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und
Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie - Partie 1:
Tubes et raccords pour adultes (ISO 5366-1:2000)
Ta slovenski standard je istoveten z: EN ISO 5366-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5366-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5366-1:2009

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SIST EN ISO 5366-1:2009
EUROPEAN STANDARD
EN ISO 5366-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 5366-1:2004
English Version
Anaesthetic and respiratory equipment - Tracheostomy tubes -
Part 1: Tubes and connectors for use in adults (ISO 5366-
1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes Anästhesie- und Beatmungsgeräte - Tracheotomietuben -
de trachéostomie - Partie 1: Tubes et raccords pour adultes Teil 1: Tuben und Verbindungsstücke zur Anwendung bei
(ISO 5366-1:2000) Erwachsenen (ISO 5366-1:2000)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5366-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (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 5366-1:2009
EN ISO 5366-1:2009 (E)
Foreword
The text of ISO 5366-1:2000 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 5366-1:2009 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 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 5366-1:2004.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmar
...