EN ISO 14408:2005

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)

In dieser Internationalen Norm sind die Kennzeichnung und die vom Hersteller bereit zu stellenden 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)

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

General Information

• Status: Withdrawn
• Publication Date: 31-May-2005
• Withdrawal Date: 14-Apr-2009
• 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: 15-Apr-2009
• Completion Date: 15-Apr-2009
• 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 ISO 14408:2005 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

Relations

• Replaced By: EN ISO 14408:2009 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
• Effective Date: 22-Apr-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14408:2005
01-september-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 14408:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 14408:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 14408:2005

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

SIST EN ISO 14408:2005
EUROPEAN STANDARD
EN ISO 14408
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2005
ICS 11.040.10
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 Kennziechnung und die begleitenden Informationen
d'accompagnement (ISO 14408:2005) (ISO 14408:2005)
This European Standard was approved by CEN on 12 May 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14408:2005: E
worldwide for CEN national Members.

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

SIST EN ISO 14408:2005

EN ISO 14408:2005 (E)





Foreword


This document (EN ISO 14408:2005) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 December 2005, and conflicting national standards
shall be withdrawn at the latest by December 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 EU Directive(s).

For relationship with EU Directive(s), 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, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 14408:2005 has been approved by CEN as EN ISO 14408:2005 without any
modifications.
2

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

SIST EN ISO 14408:2005

EN ISO 14408:2005 (E)


ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC

This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national stand
...