SIST EN ISO 11810-1:2005

SLOVENSKI STANDARD
SIST EN ISO 11810-1:2005
01-junij-2005
1DGRPHãþD
SIST EN ISO 11810:2003
Laserji in z laserji povezana oprema - Preskusna metoda in klasifikacija za
ugotavljanje odpornosti proti laserju za kirurške zastirke in/ali za varovalna
pokrivala za paciente – 1. del: Primarno zgorevanje in prodiranje (ISO 11810-
1:2005)
Lasers and laser-related equipment - Test method and classification for the laser
resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition
and penetration (ISO 11810-1:2005)
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von
Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Teil 1:
Primäre Entzündung und Laserdurchstrahlung (ISO 11810-1:2005)
Lasers et équipements associés aux lasers - Méthode d'essai et classification de la
résistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des
patients - Partie 1: Allumage primaire et pénétration (ISO 11810-1:2005)
Ta slovenski standard je istoveten z: EN ISO 11810-1:2005
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.99 Druga varovalna oprema Other protective equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
SIST EN ISO 11810-1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11810-1:2005

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SIST EN ISO 11810-1:2005



EUROPEAN STANDARD
EN ISO 11810-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2005
ICS 31.260; 13.340.99; 11.040.30 Supersedes EN ISO 11810:2002
English version
Lasers and laser-related equipment - Test method and
classification for the laser resistance of surgical drapes and/or
patient protective covers - Part 1: Primary ignition and
penetration (ISO 11810-1:2005)
Lasers et équipements associés aux lasers - Méthode Laser und Laseranlagen - Prüfverfahren und Einstufung zur
d'essai et classification de la résistance au laser pour des Laserresistenz von Operationstüchern und/oder anderen
draps chirurgicaux et/ou des couvertures de protection des Abdeckungen zum Schutz des Patienten - Teil 1: Primäre
patients - Partie 1: Allumage primaire et pénétration (ISO Entzündung und Laserdurchstrahlung (ISO 11810-1:2005)
11810-1:2005)
This European Standard was approved by CEN on 7 February 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 11810-1:2005: E
worldwide for CEN national Members.

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SIST EN ISO 11810-1:2005

EN ISO 11810-1:2005 (E)





Foreword


This document (EN ISO 11810-1:2005) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 August 2005, and conflicting national
standards shall be withdrawn at the latest by August 2005.

This document supersedes EN ISO 11810:2002.

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 11810-1:2005 has been approved by CEN as EN ISO 11810-1:2005 without any
modifications.

2

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SIST EN ISO 11810-1:2005

INTERNATIONAL ISO
STANDARD 11810-1
First edition
2005-02-15

Lasers and laser-related equipment —
Test method and classification for the
laser resistance of surgical drapes and/or
patient protective covers —
Part 1:
Primary ignition and penetration
Lasers et équipements associés aux lasers — Méthode d'essai et
classification de la résistance au laser pour des draps chirurgicaux
et/ou des couvertures de protection des patients —
Partie 1: Allumage primaire et pénétration




Reference number
ISO 11810-1:2005(E)
©
ISO 2005

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SIST EN ISO 11810-1:2005
ISO 11810-1:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 11810-1:2005
ISO 11810-1:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Test methods. 3
4.1 General conditions. 3
4.2 Testing procedure. 7
5 Classification. 8
5.1 Laser induced ignition (ΙΙ) . 8
ΙΙ
5.2 Resistance to laser penetration (P). 9
5.3 Classification definition. 9
6 Test report. 9
Bibliography . 11

© ISO 2005 – All rights reserved iii

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SIST EN ISO 11810-1:2005
ISO 11810-1:2005(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 11810-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9,
Electro-optical systems.
This first edition cancels and replaces ISO 11810:2002, which has been technically revised.
ISO 11810 consists of the following parts, under the general title Lasers and laser-related equipment — Test
method and classification for the laser resistance of surgical drapes and/or patient protective covers:
 Part 1: Primary ignition and penetration
 Part 2: Secondary ignition
iv © ISO 2005 – All rights reserved

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SIST EN ISO 11810-1:2005
ISO 11810-1:2005(E)
Introduction
Some laser applications in medicine may require laser-resistant surgical drapes or other patient protective
covers. Surgical drapes or other patient protective covers are necessary when a sterile procedure is
performed and the surrounding area needs to be protected from liquids, secretions and inadvertent laser
radiation. While conventional surgical drapes or other patient protective covers are not necessarily laser-
resistant, specifically designed drapes offer the possibility of laser resistance.
Laser induced risks include ignition, flammability, melting, penetration, thermal transfer and reflectivity. Textile
and non-woven drape materials may have other risks but they may provide a laser barrier. While there are
many potential ignition devices present in the operating room (e.g. fibre optic illumination systems, electro-
surgical units, hot wire cauteries), this test method addresses only the laser ignition source. This part of
ISO 11810 is intended for use in testing a surgical drape or other patient protective cover that claims to be
laser-resistant. In addition, areas within this product may vary in material composition or design. Depending
on the claims being made by the manufacturer or end-user requirements, all areas for which laser resistance
is claimed may need to be tested.
CO lasers may provide the most challenging conditions of all medical lasers. Ignition/flammability tests and
2
penetration tests may disclose more challenging laser wavelengths as well as modes of laser delivery, for
example Q-switching in the nanosecond range. The 20 W CO laser (continuous wave) has been selected as
2
the laser for this part of ISO 11810.
Users of this test method are cautioned that the laser resistance of a surgical drape or other patient protective
cover will be wavelength sensitive and that a surgical drape or other protective cover should be tested at the
wavelengths for which it is intended to be used. If tested using other wavelengths, the power settings and
modes of delivery need to be explicitly stated.
The results from this part of ISO 11810 should not be applied to other wavelengths and temporal formats.
The performance of laser-resistant surgical drapes or other patient protective covers may be changed when
used in combination rather than individually.
© ISO 2005 – All rights reserved v

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SIST EN ISO 11810-1:2005

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SIST EN ISO 11810-1:2005
INTERNATIONAL STANDARD ISO 11810-1:2005(E)

Lasers and laser-related equipment — Test method and
classification for the laser resistance of surgical drapes and/or
patient protective covers —
Part 1:
Primary ignition and penetration
1 Scope
This part of ISO 11810 is applicable to disposable and reusable, as well as woven and non-woven materials
used as surgical drapes and other patient protective covers which claim to be laser-resistant.
The purpose of this part of ISO 11810 is to provide a standardized method for testing and classifying surgical
drapes and other patient protective covers with respect to laser-induced hazards. An appropriate classification
system is given. It is not the purpose of this part of ISO 11810 to serve as a general fire safety specification,
and as such, this part of ISO 11810 does not cover other sources of ignition. It also does not cover the issue
of laser-induced secondary ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular
reflectance may be a hazard. This measurement, however, is not covered in this part of ISO 11810.
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 11145:2001, Optics and optical instruments — Lasers and laser-related equipment — Vocabulary and
symbols
ISO 11146-1, Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles
and beam propagation ratios —
...