EN ISO 11990:2018
(Main)Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)
This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser.
NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct applicability of the results of this test method to the clinical situation has not been fully established.
NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, explicitly state the power settings and modes of delivery.
CAUTION — This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtubusschaft und Trachealtubusmanschette (ISO 11990:2018)
Lasers et équipements associés aux lasers - Détermination de la résistance au laser des axe et ballonnet de tubes trachéaux (ISO 11990:2018)
Le présent document spécifie une méthode d'essai de la résistance au laser à onde continue d'une sonde trachéale et des régions du ballonnet conçus pour résister à l'inflammation par un laser.
NOTE 1 L'attention est attirée sur l'interprétation de ces résultats, car l'applicabilité directe des résultats de cette méthode d'essai à la situation clinique n'a pas été complètement établie.
NOTE 2 L'attention des utilisateurs des produits soumis à essai selon cette méthode est attirée sur le fait que le laser sera sensible à la longueur d'onde et que l'essai sera réalisé à la longueur d'onde pour laquelle il est destiné à être utilisé. En cas d'essai réalisé en utilisant d'autres longueurs d'onde, indiquer explicitement les paramètres de puissance et les modes d'émission.
ATTENTION — Cette méthode d'essai peut impliquer des matériaux, des fonctionnements et des équipements dangereux. Le présent document dispense des conseils sur la manière de minimiser certains risques associés à l'utilisation, mais n'a pas pour but de les traiter tous. Il incombe à l'utilisateur du présent document d'établir des pratiques appropriées en matière d'hygiène et de sécurité, et de déterminer l'applicabilité des limites réglementaires avant utilisation.
Laserji in laserska oprema - Ugotavljanje odpornosti sapničnih (endotrahealnih) tubusov in manšete proti laserskemu žarku (ISO 11990:2018)
Ta dokument določa metodo preskušanje trajne valovne (CW) laserske odpornosti sapničnih (endotrahealnih) tubusov in delov manšete, vključno s sistemom za napihovanje endotrahealnih tubusov, ki so namenjeni za preprečevanje vžiga z laserskim žarkom.
OPOMBA 1: Pri razlagi teh rezultatov je treba uporabnika opozoriti, da neposredna uporabnost rezultatov te preskusne metode za klinične postopke ni bila v celoti ugotovljena. OPOMBA 2: Uporabnike izdelkov, preskušenih s to metodo, je treba opozoriti, da bo laser občutljiv na valovno dolžino in da je preskus priporočljivo izvesti pri valovni dolžini, za katero je predvidena njegova uporaba. Če se preskus izvede pri drugih valovnih dolžinah, je treba izrecno navesti nastavitve moči in načine izvedbe.
OPOZORILO: Ta preskusna metoda lahko vključuje nevarne materiale, postopke in opremo. Ta dokument podaja nasvete o zmanjševanju nekaterih tveganj, povezanih z njeno uporabo, vendar ne obravnava vseh takšnih tveganj. Za vzpostavitev ustreznih varnostnih in zdravstvenih praks ter za določitev uporabnosti regulativnih omejitev pred uporabo je odgovoren uporabnik tega dokumenta.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2018
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SIST EN ISO 11990-1:2015
SIST EN ISO 11990-2:2015
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Lasers and laser-related equipment - Determination of laser resistance of tracheal tube
shaft and tracheal cuffs (ISO 11990:2018)
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtubusschaft und
Trachealtubusmanschette (ISO 11990:2018)
Lasers et équipements associés aux lasers - Détermination de la résistance au laser des
axe et ballonnet de tubes trachéaux (ISO 11990:2018)
Ta slovenski standard je istoveten z: EN ISO 11990:2018
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11990
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 31.260; 11.040.10 Supersedes EN ISO 11990-1:2014, EN ISO 11990-
2:2014
English Version
Lasers and laser-related equipment - Determination of
laser resistance of tracheal tube shaft and tracheal cuffs
(ISO 11990:2018)
Lasers et équipements associés aux lasers - Laser und Laseranlagen - Bestimmung der
Détermination de la résistance au laser des axe et Laserresistenz von Trachealtubusschaft und
ballonnet de tubes trachéaux (ISO 11990:2018) Trachealtubusmanschette (ISO 11990:2018)
This European Standard was approved by CEN on 5 August 2018.
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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4
European foreword
This document (EN ISO 11990:2018) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" in collaboration with Technical Committee CEN/TC 123 “Lasers and photonics” the
secretariat of which is held by DIN.
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 April 2019, and conflicting national standards shall be
withdrawn at the latest by April 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11990-1:2014 and EN ISO 11990-2:2014.
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 the 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11990:2018 has been approved by CEN as EN ISO 11990:2018 without any modification.
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request ‘M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of
14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/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 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 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 [OJ L
169]
Essential Requirements of Clause(s)/sub-clause(s) of
Remarks/Notes
Directive 93/42/EEC this European Standard
7.1 (first indent only) This entire standard These Essential Requirements
(ERs) are partly covered. This
7.3 (first part only) This entire standard
standard is intended to
provide a test method that will
9.3 This entire standard
allow an evaluation of the risk
of ignition of the shaft and cuff
of a tracheal tube associated
with its use with lasers during
ear, nose and throat surgery as
part of the risk assessment as
set out in these essential
requirements.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references as Equivalent dated standard
listed in Clause 2
EN ISO
ISO 11146-1 EN ISO 11146-1:2005 ISO 11146-1:2005
ISO 11810 EN ISO 11810:2015 EN ISO 11810:2015
ISO/IEC Guide 99 — ISO/IEC Guide 99:2007
ISO 5361:2016 EN ISO 5361:2016 ISO 5361:2016
ISO 11145:2016 EN ISO 11145:2016 ISO 11145:2016
INTERNATIONAL ISO
STANDARD 11990
Third edition
2018-08
Lasers and laser-related
equipment — Determination of laser
resistance of tracheal tube shaft and
tracheal tube cuffs
Lasers et équipements associés aux lasers — Détermination de la
résistance au laser des axe et ballonnet de tubes trachéaux
Reference number
ISO 11990:2018(E)
©
ISO 2018
ISO 11990:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 11990:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 3
5 Significance and use of the test. 3
6 Apparatus . 4
6.1 General . 4
6.2 Containment box . 4
6.3 Specimen holder . 5
6.4 Lasers and delivery systems . 7
6.5 Power meter . 7
6.6 Gas supply system . 7
6.7 Environment . 7
6.7.1 Ambient air conditions . 7
6.7.2 Oxygen enriched atmospheres . 8
6.8 Smoke eva
...
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