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CEN

EN ISO 14408:2016

(Main)

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)

ISO 14408:2016 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 14408:2016)

Diese Internationale Norm legt Aufschriften, Kennzeichnung und die vom Hersteller bereitzustellenden Informationen für Trachealtuben mit und ohne Cuff sowie zugehörige Materialien fest, die dafür ausgelegt sind, der Entzündung durch einen Laser standzuhalten.

Tubes trachéaux destinés aux opérations laser - Exigences relatives au marquage et aux informations d'accompagnement (ISO 14408:2016)

ISO 14408:2016 spécifie le marquage, l'étiquetage et les informations devant être fournies par le fabricant concernant les tubes trachéaux avec ou sans ballonnet et le matériel connexe conçus pour résister à l'ignition provoquée par un laser.

Sapnični (endotrahealni) tubusi za lasersko kirurgijo - Zahteve za označevanje in spremne podatke (ISO 14408:2016)

Ta mednarodni standard določa označevanje, etiketiranje in podatke, ki jih mora proizvajalec priložiti sapničnim (endotrahealnim) tubusom s tesnilnim mešičkom ali brez njega in povezanim materialom, zasnovanim tako, da so odporni na vžig z laserskim žarkom.

General Information

Status
Published
Publication Date
15-Mar-2016
Withdrawal Date
15-Mar-2019
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Mar-2016
Completion Date
16-Mar-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
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 14408:2016 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)

Relations

Replaces
EN ISO 14408:2009 - Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
Effective Date
23-Mar-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14408:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 14408:2009
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VSUHPQHSRGDWNH ,62
Tracheal tubes designed for laser surgery - Requirements for marking and
accompanying information (ISO 14408:2016)
Trachealtuben für die Laserchirurgie - Anforderungen an die Kennzeichnung und die
begleitenden Informationen (ISO 14408:2016)
Tubes trachéaux destinés aux opérations laser - Exigences relatives au marquage et aux
informations d'accompagnement (ISO 14408:2016)
Ta slovenski standard je istoveten z: EN ISO 14408:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 14408:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14408:2016

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SIST EN ISO 14408:2016


EN ISO 14408
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 14408:2009
English Version

Tracheal tubes designed for laser surgery - Requirements
for marking and accompanying information (ISO
14408:2016)
Tubes trachéaux destinés aux opérations laser - Trachealtuben für die Laserchirurgie - Anforderungen
Exigences relatives au marquage et aux informations an die Kennzeichnung und die begleitenden
d'accompagnement (ISO 14408:2016) Informationen (ISO 14408:2016)
This European Standard was approved by CEN on 30 January 2016.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14408:2016 E
worldwide for CEN national Members.

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SIST EN ISO 14408:2016
EN ISO 14408:2016 (E)
Contents Page
European 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 14408:2016
EN ISO 14408:2016 (E)
European foreword
This document (EN ISO 14408:2016) 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 September 2016, and conflicting national standards
shall be withdrawn at the latest by March 2019.
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 14408:2009.
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, Bulgaria,
Cr
...

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