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Withdrawn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
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
26-Oct-2016
Completion Date
26-Oct-2016

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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
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

....................................................................................................................................................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 ............................................................................................................................................ 10 6.5 Cuff ....................................................................................................................................................... 10 6.6 Inflating tubes for cuffs ...................................................................................................................... 10 6.7 Patient end ........................................................................................................................................... 10 6.8 Introducer ............................................................................................................................................ 10 7 Requirements for tracheostomy tubes supplied sterile ................................................................. 11 7.1 Sterility assurance .............................................................................................................................. 11 7.2 Packaging for tracheostomy tubes supplied sterile ....................................................................... 11 8 Marking ................................................................................................................................................ 11 8.1 Marking of tracheostomy tube .......................................................................................................... 11 8.2 Marking of tracheostomy tube connectors ...................................................................................... 11 8.3 Marking of unit packs ......................................................................................................................... 11 9 Adaptor ................................................................................................................................................ 13 Annex A (normative)
Test for security of attachment of permanently attached connector, if provided, and neck-plate to tracheostomy tube . 14 A.1 Principle . 14 A.2 Apparatus . 14 A.3 Procedure . 14 A.4 Expression of results . 15 Annex B (normative)
Test method for determining the resting diameter of the cuff . 16 B.1 Principle . 16 B.2 Apparatus . 16 B.3 Procedure . 16 B.4 Expression of results . 16 Annex C (informative)
Guidance on materials and design . 17 C.1 Materials . 17 C.2 Design . 17 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices . 18 Bibliography . 20
1See ISO/TR 11991. SIST EN 1282-2:2005+A1:2009
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