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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2016
1DGRPHãþD
SIST EN ISO 14408:2009
6DSQLþQL HQGRWUDKHDOQL WXEXVL]DODVHUVNRNLUXUJLMR=DKWHYH]DR]QDþHYDQMHLQ
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
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,
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 the United Kingdom.
Endorsement notice
The text of ISO 14408:2016 has been approved by CEN as EN ISO 14408:2016 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 Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union 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 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made,
the risk management process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/EEC, as
amended by 2007/47/EC. This means that risks have to be reduced "as far as possible", "to a minimum", "to the
lowest possible level", "minimized" or "removed", according to the wording of the corresponding essential
requirement.
NOTE 2 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
4.3 g) 8.7 Partly covered. Marked sterile if
appropriate.
4.4 g)
5.2.2 9.1 Partly covered, limited to information
relating to use with laser surgery
5.5.4, 5.9, 5.5.1
equipment.
4.2.2 b) 9.2 (first and second indent) Partly covered to address only the risk
of injury in connection with their
4.2.3
physical features by specifying sizing
4.3 d), e), j)
and marking conventions for the
4.4 d), e)
ID/OD of the tracheal tube, optional
positioning marks, marking for the OD
of the cuff.
4.2.3 10.2 Partly addressed with optional marks
to aid in intubation positioning.
4 13.1 Partly covered by mandating limited
marking and labelling and instructions
on the tube, unit and packing labels,
and instructions for use.
4.1 13.2 Partly covered. Symbols are mandated
to conform to ISO 7000 or -
EN ISO 15223-1
4.2.2 a) 13.3 a) Name and or trademark of
manufacturer or supplier mandated on
4.3 b)
the device and on individual pack.
4.4 b) Authorized representative mandated
4.3 a) 13.3 b)
4.4 a)
4.3 g) 13.3 c) Only identifies that the device is sterile
(if applicable).
4.4 g)
4.3 f) 13.3 d) Very limited only to the choice of either
a batch number or serial number or
4.4 f)
year of manufacture on the individual
pack; batch number on the shelf/multi-
pack.
4.3 k) 13.3 e)
4.4 i)
4.3 h) 13.3 f)
4.4 h)
4.2.2 d) 13.3 i) Limited to information regarding laser
resistance and related special set-up
4.3 j)
instructions
4.4 k)
5.1.1
4.3 l) 13.3 i) Limited to information charts
regarding laser resistance.
4.4 l)
5.4
4.3 l) 13.3 j) Limited to information charts
regarding laser resistance.
4.4 l)
5.4
5.3 13.3 k)
4 13.6 a) Mandated markings, labelling and
instructions, limited to those listed
above.
5.4 13.6 b) Limited to information charts
regarding laser resistance.
5.1.2 13.6 h), first sentence Partly covered to mandated
instructions for cleaning and
disinfection or sterilization.
5.1.1 13.6 i) Limited to details for preparation for
use related to laser resistance.
5.3 13.4 l) Party covered to precautions relating
to contact with lasers.
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this document.
INTERNATIONAL ISO
STANDARD 14408
Third edition
2016-02-15
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 14408:2016(E)
©
ISO 2016
ISO 14408:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved
ISO 14408:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Marking and labelling . 2
4.1 Use of symbols . 2
4.2 Marking . 2
4.3 Labelling of packs . 3
4.4 Labelling of shelf or multi-unit containers . 3
5 Information to be supplied by the manufacturer . 4
5.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal
tube treatments . 4
5.2 Indications for use . 4
5.3 Warnings and precautions about the use of the tube . 4
5.4 Graph showing test results for laser resistance . 4
Bibliography . 7
ISO 14408:2016(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.
The procedures used to develop this document a
...
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