EN 1282-2:2005/prA1

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
• 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/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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1282-2:2005/kprA1:2009
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
SIST EN 1282-2:2005/kprA1:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 1282-2:2005/kprA1:2009

---------------------- Page: 2 ----------------------

SIST EN 1282-2:2005/kprA1:2009
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.

---------------------- Page: 3 ----------------------

SIST EN 1282-2:2005/kprA1:2009
EN 1282-2:2005/prA1:2009 (E)
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 . 5

2

---------------------- Page: 4 ----------------------

SIST EN 1282-2:2005/kprA1:2009
EN 1282-2:2005/prA1:2009 (E)
Foreword
This document (EN 1282-2:2005/prA1:2009) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This document is currently submitted to the Unique Acceptance Procedure.
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(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of
this document.
3

---------------------- Page: 5 ----------------------

SIST EN 1282-2:2005/kprA1:2009
EN 1282-2:2005/prA1:2009 (E)
1 Modification to Clause 5

Add the following paragraphs:
"If phthalates are incorporated in parts of the medical devices coming directly or indirectly into
contact with the patient the medical device shall be labelled accordingly.
...