EN ISO 14408:2009
(Main)Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
ISO 14408:2005 specifies marking, labelling and information 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 14408:2005
6DSQLþQL HQGRWUDKHDOQL 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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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
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, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14408:2005 has been approved by CEN as a EN ISO 14408:2009 without any modification.
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 on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
4.1 13.2
4.2 13.1
4.2.8 13.3 m)
4.3 13.3
4.3 a) 13.3 b), 13.4
4.3 b) 13.3 a)
4.3 c) 13.3 d)
4.3 d) 13.3 b)
4.3 e) 13.3 b)
4.3 f) 13.3 d)
4.3 g) 8.7, 13.3 c)
4.3 h) 13.3 f)
4.3 i) 13.3 b)
4.3 j) 13.3 i)
4.3 k) 13.3 e)
4.3 l) 13.3 j)
4.4 a) 13.3 b)
4.4 b) 13.3 b)
4.4 c) 13.3 d)
4.4 d) 13.3 b)
4.4 e) 13.3 b)
4.4 f) 13.3 d)
4.4 g) 8.7, 13.3 c)
4.4 h) 13.3 f)
4.4 i) 13.3 e)
4.4 k) 13.3 i)
4.4 l) 1.3, 13.6 c)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
5.1.1 13.6 d)
5.1.2 13.6 h)
5.2 13.1, 13.6 c)
5.3 13.1, 13.6 b)
5.4 13.1, 13.3 j)
1 through 5 13.1
- 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this Standard
- 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this Standard
- 13.6 (h) (2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this Standard
- 13.6 (h) (3rd paragraph) This relevant Essential
Requirement is not fully
addressed in this Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 14408
Second edition
2005-06-01
Tracheal tubes designed for laser
surgery — Requirements for marking and
accompanying information
Tubes trachéaux destinés aux opérations laser — Exigences relatives
au marquage et aux informations d'accompagnement
Reference number
ISO 14408:2005(E)
©
ISO 2005
ISO 14408:2005(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved
ISO 14408:2005(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14408 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This second edition cancels and replaces the first edition (ISO 14408:1998), Clauses 4 and 5 and Figure 1 of
which have been technically revised.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
ISO 14408:2005(E)
Introduction
This International Standard is intended to provide requirements for marking, labelling and information supplied
for tracheal tubes which are designed for resistance to ignition by a laser and which have been tested for laser
resistance in accordance with ISO 11990 including a standard format for reporting results obtained when
tested in accordance with ISO 11990. It is intended that, by limiting the requirements to disclosure of
information determined in accordance with standard test methods, the manufacturer will be allowed maximum
use of alternatives in design and materials.
iv © ISO 2005 – All rights reserved
INTERNATIONAL STANDARD ISO 14408:2005(E)
Tracheal tubes designed for laser surgery — Requirements
for marking and accompanying information
1 Scope
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 11990, Optics and optical instruments — Lasers and laser-related equipment — Determination of laser
resistance of tracheal tube shafts
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
tracheal tube
tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the
trachea
[ISO 4135:2001]
3.2
cuff
inflatable balloon permanently attached around the tracheal tube near the patient end to provide an effective
seal between the tube and the trachea
NOTE Adapted from ISO 4135:2001.
3.3
laser-resistant tracheal tube
tracheal tube specifically designed by the manufacturer for use during laser surgery of the airway
NOTE This includes devices sold preassembled or in kit form.
3.4
laser-resistant tracheal tube treatment
covering and/or surface treatment that adapts or modifies non-laser-resistant tracheal tubes for use in laser
surgery of the airway
ISO 14408:2005(E)
3.5
upper anatomical airway
upper airway
airway above the laryngotracheal junction
3.6
laser-resistant portion
that portion of the tracheal tube intended by the manufacturer to be laser-resistant
4 Marking and labelling
4.1 Use of symbols
The requirements given in 4.2, 4.3, and 4.4 may be met by the use of the appropriate symbols in accordance
with ISO 7000 or EN 980.
4.2 Marking
4.2.1 Marking of tracheal tubes, connectors, packages, inserts and information to be supplied by the
manufacturer should comply with EN 1041.
4.2.2 The following shall be permanently marked on or affixed to the tracheal tube or tracheal tube
treatment:
a) the name and/or trademark of the m
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.