SIST EN ISO 14408:2005
(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)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14408:2005
01-september-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 14408:2005
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.
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SIST EN ISO 14408:2005
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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.
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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
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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 standard in at least one Member State, compliance with
the normative 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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
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)
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)
3
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SIST EN ISO 14408:2005
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SIST EN ISO 14408:2005
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
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SIST EN ISO 14408:2005
ISO 14408:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 14408:2005
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 2005 – All rights reserved iii
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SIST EN ISO 14408:2005
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
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SIST EN ISO 14408:2005
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