EN 1282-2:2005

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

This document specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given.
This document is not applicable to specialized tracheostomy tubes.

Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)

Diese Europäische Norm legt Anforderungen an pädiatrische Tracheotomietuben aus Kunststoffen und/oder
Gummi mit einem Innendurchmesser von 2,0 mm bis 6,0 mm fest. Es enthält auch Anforderungen an
Verbindungsstücke und Adapter für pädiatrische Tracheotomietuben.
Spezial-Tracheotomietuben gehören nicht zum Anwendungsbereich dieses Dokuments.

Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)

La présente Norme européenne spécifie les prescriptions relatives aux tubes de trachéostomie pédiatriques
en matière plastique et/ou en caoutchouc dont le diamètre intérieur est compris entre 2,0 mm et 6,0 mm. Les
prescriptions relatives aux raccords et adaptateurs de tubes de trachéostomie pédiatriques sont également
spécifiées.
Le présent document ne s�applique pas aux tubes de trachéostomie spécialisés.

Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-3:2001, spremenjen)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2005
• Withdrawal Date: 11-Aug-2009
• 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
• Start Date: 12-Aug-2009
• Completion Date: 12-Aug-2009
• 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 1282-2:2005 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

Relations

• Replaces: EN 1282-2:1997 - Tracheostomy tubes - Part 2: Pediatric tubes
• Effective Date: 22-Dec-2008
• Merged Into: EN 1282-2:2005+A1:2009 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
• Effective Date: 19-Jan-2023
• Amended By: EN 1282-2:2005/prA1 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1282-2:2005
01-september-2005
1DGRPHãþD
SIST EN 1282-2:2000
Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-
3:2001, spremenjen)
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)
Ta slovenski standard je istoveten z: EN 1282-2:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 1282-2:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1282-2:2005

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SIST EN 1282-2:2005



EUROPEAN STANDARD EN 1282-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2005
ICS 11.040.10 Supersedes EN 1282-2:1997
English version
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-
3:2001, modified)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-
5366-3:2001, modifiée) 3:2001, geändert)
This European Standard was approved by CEN on 25 April 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1282-2:2005: E
worldwide for CEN national Members.

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SIST EN 1282-2:2005
EN 1282-2:2005 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Size designation and dimensions.6
4.1 Designation of size of tube .6
4.2 Outside diameter.6
4.3 Length .7
4.4 Angle θ .8
5 Materials .8
6 Design and finish.8
6.1 Machine end .8
6.2 Paediatric tracheostomy tube connector.8
6.3 Inner tube.
...