EN 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

• Status: Published
• Publication Date: 16-Oct-2018
• Withdrawal Date: 29-Apr-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: CEN/TC 123 - Lasers and photonics
• Drafting Committee: CEN/TC 123 - Lasers and photonics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Oct-2018
• Completion Date: 17-Oct-2018
• Directive: 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 11990:2018 - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

Relations

• Replaces: EN ISO 11990-1:2014 - Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
• Effective Date: 24-Oct-2018
• Replaces: EN ISO 11990-2:2014 - Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
• Effective Date: 08-Jul-2015

Overview

EN ISO 11990:2018 (ISO 11990:2018) specifies a laboratory test method for determining the continuous‑wave (cw) laser resistance of tracheal tube shafts and tracheal tube cuffs (including the cuff inflation system). Prepared by ISO/TC 172 in collaboration with CEN, this third‑edition standard consolidates earlier part 1/2 documents and provides a harmonized procedure to evaluate the risk of laser ignition of airway devices used during laser‑assisted procedures.

Key cautionary notes in the standard:

• Results’ direct applicability to clinical scenarios has not been fully established.
• Laser response is wavelength sensitive; tests should be reported with the wavelength, power settings and delivery mode used.
• The method can involve hazardous operations; users must implement appropriate safety and health practices.

Key Topics

• Scope: Defines tested elements - tracheal tube shaft, cuff regions and inflation systems - against cw lasers.
• Principle and significance: Outlines what is being measured and how test outcomes relate to device risk assessment.
• Apparatus and environment:
  • Containment box and specimen holder requirements
  • Laser delivery systems and power meter specifications
  • Gas supply system and handling of oxygen‑enriched atmospheres
  • Smoke evacuation device and ambient condition controls
• Specimen preparation: How to prepare representative samples of shaft and cuff for testing.
• Test methods:
  • Specific procedures for shaft and cuff irradiation
  • General test conditions and laser delivery modes
• Interpretation and reporting:
  • Criteria to record observations, damage, ignition events
  • Required contents of the test report
• Normative references: Cites related ISO standards (for example ISO 11146, ISO 11810, ISO 5361) that support measurement and test reproducibility.

Applications

• Medical device manufacturers: Evaluate and document the laser resistance performance of endotracheal and tracheal tubes during product development and regulatory submissions.
• Regulatory and conformity assessment: Use as a voluntary harmonized test method to support risk assessments under medical device directives and to demonstrate conformity with relevant essential requirements.
• Hospital laser safety officers and clinical engineers: Inform procurement choices and intraoperative risk mitigation for ENT and other laser procedures involving the airway.
• Test laboratories: Implement standardized procedures for reproducible, comparable laboratory testing of airway device materials and assemblies.

Related standards

• ISO 11810 (laser‑resistant materials testing references)
• ISO 5361 (single‑use tracheal tube standards)
• ISO 11145 / ISO 11146 (laser beam characterization) These referenced documents are normative within EN ISO 11990:2018 and support accurate laser delivery and measurement.

EN ISO 11990:2018 is an essential reference when assessing laser safety and the potential for laser‑induced ignition of airway devices, but test results should be integrated with clinical risk assessment and device‑specific considerations.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2018
1DGRPHãþD
SIST EN ISO 11990-1:2015
SIST EN ISO 11990-2:2015
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLKHQGRWUDKHDOQLK
WXEXVRYLQPDQãHWHSURWLODVHUVNHPXåDUNX,62
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
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 evacuation device . 8
7 Reagents and materials . 8
8 Preparation of test specimens . 8
9 Preparation of apparatus . 9
10 Test methods . 9
10.1 General conditions . 9
10.2 Shaft . 9
10.3 Cuff .10
11 Interpretation of results .11
12 Test report .11
Bibliography .13
ISO 11990:2018(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 and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 9, Laser and electro-optical systems.
This third edition of ISO 11990 cancels and replaces ISO 11990-1:2011 and ISO 11990-2:2010 which
have undergone a revision in order to adjust the two documents to each other thereby eliminating
redundancies and unintended discrepancies.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved

ISO 11990:2018(E)
Introduction
A fire in the airway is always a serious matter. In addition to local damage in the larynx, injury can
occur to the lower airway and the parenchymal tissue in the lung. The products of combustion can be
blown into the lungs.
Procedures performed in the airway, where a tracheal tube and a laser are used, bring together an
oxygen-enriched atmosphere, a fuel and high power, the three ingredients necessary to create a fire. The
likelihood that a laser beam will contact the tracheal tube during airway procedures is high. This led
to the development of a test method, described in this document, to assist the clinician in determining
which tracheal tube shaft was the most laser-resistant under a defined set of conditions.
Unfortunately, fires with tracheal tubes, whose shafts were laser-resistant according to this document
have continued to occur. Investigations have shown that the cuff, and not the shaft, of the tracheal tube
is the area of lowest laser resistance and most likely to be contacted by the laser beam, even when used
according to the manufacturer's instructions. Clinical experience has shown that not only perforation
of the part of the shaft below the cuff has happened, but also ignition of the outer surface of the cuff.
This could then ignite other parts of the tracheal tube, such as the tip, which is normally unprotected.
INTERNATIONAL STANDARD ISO 11990:2018(E)
Lasers and laser-related equipment — Determination of
laser resistance of tracheal tube shaft and tracheal tube
cuffs
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 11146-1, Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles
and beam propagation ratios — Part 1: Stigmatic and simple astigmatic beams
ISO 11810, Lasers and laser-related equipment — Test method and classification for the laser resistance
of surgical drapes and/or patient protective covers — Primary ignition, penetration, flame spread and
secondary ignition
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
ISO 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 11145:2016, Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11810, ISO/IEC Guide 99 and
the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
ISO 11990:2018(E)
3.1
beam diameter
d
smallest diameter of a circular aperture in a plane perpendicular to the beam axis that contains 95 % of
the total beam power (energy)
[SOURCE: ISO 11145:2016, 3.3.1, modified — The value of contained total beam power has been set to
95 %, and the note to entry has been removed.]
3.2
beam cross-sectional area
A
smallest completely filled area contain
...