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CEN

EN 1282-2:2005/prA1

(Amendment)

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

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

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

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
Not Published
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
5060 - Closure of Vote - Formal Approval
Start Date
15-Jun-2009
Completion Date
15-Jun-2009
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
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/kprA1:2009 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

Relations

Merged Into
EN 1282-2:2005+A1:2009 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Effective Date
18-Jan-2023
Amends
EN 1282-2:2005 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
01-april-2009
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, modifiziert)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)
Ta slovenski standard je istoveten z: EN 1282-2:2005/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1282-2:2005
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.040.10
English Version
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-
3:2001, modified)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-
(ISO 5366-3:2001, modifiée) 3:2001, geändert)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.
This draft amendment A1, if approved, will modify the European Standard EN 1282-2:2005. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1282-2:2005/prA1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword . 3
1 Modification to Clause 5 . 4
2 Addition of 6.2.5 – 6.2.7 . 4
3 Modification to 8.3.1 . 4
4 Modification to 8.3.2 h) . 4
5 Modification to 8.3.2 l) . 4
6 Modifications to Annex ZA .
...

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