SIST EN ISO 14408:2009

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

This International Standard specifies marking, labelling and information to be supplied by the manufacturer for
cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.

Trachealtuben für die Laserchirurgie - Anforderungen an die Kennzeichnung und die begleitenden Informationen (ISO 14408:2005)

In dieser Internationalen Norm sind die Kennzeichnung und die vom Hersteller bereitzustellenden
Informationen für Trachealtuben mit und ohne Cuff und zugehörige Geräte festgelegt, die als durch
Laserstrahlung nicht entflammbar konstruiert sind.

Tubes trachéaux destinés aux opérations laser - Exigences relatives au marquage et aux informations d'accompagnement (ISO 14408:2005)

L'ISO 14408:2005 spécifie le marquage, l'étiquetage et les informations fournies par le fabricant concernant les tubes trachéaux avec ou sans ballonnet et le matériel connexe conçu pour résister à l'ignition provoquée par le laser.

Sapnični (endotrahealni) tubusi za lasersko kirurgijo - Zahteve za označevanje in spremne podatke (ISO 14408:2005)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2009
• Withdrawal Date: 19-Apr-2016
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Apr-2016
• Due Date: 13-May-2016
• Completion Date: 20-Apr-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: EN ISO 14408:2009 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

Relations

• Replaces: SIST EN ISO 14408:2005 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
• Effective Date: 01-Jul-2009
• Replaced By: SIST EN ISO 14408:2016 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
• Effective Date: 01-May-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14408:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 14408:2005
6DSQLþQLHQGRWUDKHDOQLWXEXVL]DODVHUVNRNLUXUJLMR=DKWHYH]DR]QDþHYDQMHLQ
VSUHPQHSRGDWNH,62
Tracheal tubes designed for laser surgery - Requirements for marking and
accompanying information (ISO 14408:2005)
Trachealtuben für die Laserchirurgie - Anforderungen an die Kennzeichnung und die
begleitenden Informationen (ISO 14408:2005)
Tubes trachéaux destinés aux opérations laser - Exigences relatives au marquage et aux
informations d'accompagnement (ISO 14408:2005)
Ta slovenski standard je istoveten z: EN ISO 14408:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 14408:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14408:2009

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SIST EN ISO 14408:2009
EUROPEAN STANDARD
EN ISO 14408
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 14408:2005
English Version
Tracheal tubes designed for laser surgery - Requirements for
marking and accompanying information (ISO 14408:2005)
Tubes trachéaux destinés aux opérations laser - Exigences Trachealtuben für die Laserchirurgie - Anforderungen an
relatives au marquage et aux informations die Kennzeichnung und die begleitenden Informationen
d'accompagnement (ISO 14408:2005) (ISO 14408:2005)
This European Standard was approved by CEN on 21 March 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 Ref. No. EN ISO 14408:2009: E
worldwide for CEN national Members.

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SIST EN ISO 14408:2009
EN ISO 14408:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 14408:2009
EN ISO 14408:2009 (E)
Foreword
The text of ISO 14408:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 14408:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14408:2005.
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.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan
...