EN 1282-2:2005+A1:2009

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

This European Standard 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, modifiziert)

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)

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

General Information

• Status: Withdrawn
• Publication Date: 11-Aug-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
• Start Date: 26-Oct-2016
• 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 1282-2:2005+A1:2009 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

Relations

• Merged From: EN 1282-2:2005 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
• Effective Date: 19-Jan-2023
• Merged From: EN 1282-2:2005/prA1 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
• Effective Date: 18-Jan-2023
• Replaced By: EN ISO 5366:2016 - Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
• Effective Date: 15-Mar-2017

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-3:2001, spremenjen)Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 1282-2:2005+A1:2009SIST EN 1282-2:2005+A1:2009en,de01-oktober-2009SIST EN 1282-2:2005+A1:2009SLOVENSKI
STANDARD



SIST EN 1282-2:2005+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1282-2:2005+A1
August 2009 ICS 11.040.10 Supersedes EN 1282-2:2005English Version
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)
Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert) This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1 approved by CEN on 16 July 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 worldwide for CEN national Members. Ref. No. EN 1282-2:2005+A1:2009: ESIST EN 1282-2:2005+A1:2009



EN 1282-2:2005+A1:2009 (E) 2 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
....................................................................................................................................................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 ................................................................................................................................................9 6.4 Neck-plate ...........................................................................
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