EN ISO 11810:2015

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 11810:2015)

ISO 11810:2015 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 International Standard 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 International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.
The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items
NOTE          Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.

Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Primäre Entzündung, Laserdurchstrahlung und sekundäre Entzündung (ISO 11810:2015)

Diese Internationale Norm gilt für Einwegprodukte und wieder verwendbare gewebte Materialien und Vlies-stoffe, die als Operationstücher und andere Abdeckungen zum Schutz des Patienten mit dem Anspruch auf Laserstrahlungsbeständigkeit verwendet werden. Der Zweck dieser Internationalen Norm ist, ein genormtes Verfahren zur Prüfung und Einstufung von Operationsabdecktüchern und anderen Abdeckungen zum Schutz des Patienten hinsichtlich der durch Laser hervor gerufenen Gefährdungen zur Verfügung zu stellen. Ein geeignetes Einstufungssystem wird angegeben. Der Zweck dieser Internationalen Norm besteht nicht darin, als allgemeine Brandsicherheits¬vorschrift zu dienen, und insofern werden andere Zündquellen von dieser Norm nicht erfasst.
Alle Materialien reflektieren Anteile des Strahls, und es ist für den Anwender erforderlich, zu entscheiden, ob die spiegelnde Reflexion eine Gefährdung darstellen kann. Diese Messungen werden jedoch in dieser Internationalen Norm nicht erfasst.
Das Prüfverfahren kann genutzt werden, um durch Laser hervorgerufene Entflammbarkeitseigenschaften von nicht-laserresistenten Materialien zu bewerten.
ANMERKUNG   Die Anwender der nach diesem Verfahren geprüften Produkte werden warnend darauf hingewiesen, dass die Laserstrahlungsbeständigkeit eines Operationstuches und/oder einer anderen Abdeckung zum Schutz des Patienten von der Wellenlänge abhängt und dass das Tuch und/oder die Abdeckung besser bei der Wellenlänge geprüft werden sollte, für die ihr Einsatz vorgesehen ist. Bei Prüfung unter Anwendung anderer Wellenlängen sind die Leistungswerte und Anregungsarten explizit anzugeben.

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 - Inflammation principale, pénétration et inflammation secondaire (ISO 11810:2015)

Laserji in z laserji povezana oprema - Preskusna metoda in klasifikacija za ugotavljanje odpornosti proti laserju za operacijska pokrivala in/ali za varovalna pokrivala za paciente - Primarno zgorevanje, prodiranje, širjenje plamena in sekundarno zgorevanje (ISO 11810:2015)

Ta mednarodni standard velja za materiale za enkratno in večkratno uporabo ter tudi za tkane in netkane materiale, ki se uporabljajo kot operacijska pokrivala in druga varovalna pokrivala za paciente, ki naj bi bila odporna proti laserju. Namen tega mednarodnega standarda je zagotoviti standardizirano metodo za preskušanje in klasificiranje operacijskih pokrival in drugih varovalnih pokrival za paciente v zvezi z nevarnostmi, ki jih predstavlja laser.
Podan je primeren sistem klasifikacije. Tega mednarodnega standarda se ne sme uporabljati kot splošne specifikacije na področju požarne varnosti, in kot takšen ne zajema drugih virov vžiga.
Vsi materiali zrcalijo dele žarka, zato se mora uporabnik odločiti, ali lahko refleksijska odbojnost predstavlja nevarnost. Vendar ta meritev ni zajeta v tem mednarodnem standardu.
Za oceno lastnosti gorljivosti, ki jo povzroči laser pri elementih, ki niso odporni proti laserju, je mogoče uporabiti preskusni
postopek.
OPOMBA: Uporabniki izdelkov, ki so bili preskušeni s to metodo, morajo upoštevati, da je odpornost proti laserju operacijskega pokrivala
in/ali varovalnega pokrivala za paciente občutljiva na valovno dolžino, pri čemer je priporočljivo operacijsko pokrivalo in/ali varovalno pokrivalo za paciente preskusiti pri valovni dolžini, pri kateri se bo uporabljalo. Če se preskus izvede pri drugih valovnih dolžinah, je treba izrecno navesti nastavitve moči in načine izvedbe.

General Information

• Status: Published
• Publication Date: 30-Mar-2016
• Withdrawal Date: 29-Jun-2016
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.99 - Other protective 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: 23-Dec-2015
• Completion Date: 23-Dec-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 11810:2016 - 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 11810:2015)

Relations

• Replaces: EN ISO 11810-1:2009 - 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)
• Effective Date: 30-Dec-2015
• Replaces: EN ISO 11810-2:2009 - Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
• Effective Date: 30-Dec-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11810:2016
01-marec-2016
1DGRPHãþD
SIST EN ISO 11810-1:2009
SIST EN ISO 11810-2:2009
Laserji in z laserji povezana oprema - Preskusna metoda in klasifikacija za

ugotavljanje odpornosti proti laserju za operacijska pokrivala in/ali za varovalna

pokrivala za paciente - Primarno zgorevanje, prodiranje, širjenje plamena in
sekundarno zgorevanje (ISO 11810:2015)

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 11810:2015)
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von

Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Primäre

Entzündung, Laserdurchstrahlung und sekundäre Entzündung (ISO 11810:2015)

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 - Inflammation principale, pénétration et inflammation secondaire (ISO
11810:2015)
Ta slovenski standard je istoveten z: EN ISO 11810:2015
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
13.340.99 Druga varovalna oprema Other protective equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
SIST EN ISO 11810:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11810:2016
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SIST EN ISO 11810:2016
EN ISO 11810
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.30; 13.340.99; 31.260 Supersedes EN ISO 11810-1:2009, EN ISO 11810-
2:2009
English Version
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
11810:2015)

Lasers et équipements associés aux lasers - Méthode Laser und Laseranlagen - Prüfverfahren und

d'essai et classification de la résistance au laser pour Einstufung zur Laserresistenz von Operationstüchern

des draps chirurgicaux et/ou des couvertures de und/oder anderen Abdeckungen zum Schutz des

protection des patients - Inflammation principale, Patienten - Primäre Entzündung, Laserdurchstrahlung

pénétration et inflammation secondaire (ISO und sekundäre Entzündung (ISO 11810:2015)

11810:2015)
This European Standard was approved by CEN on 24 October 2015.

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

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11810:2015 E

worldwide for CEN national Members.
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SIST EN ISO 11810:2016
EN ISO 11810:2015 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ............................................................................................ 4

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SIST EN ISO 11810:2016
EN ISO 11810:2015 (E)
European foreword

This document (EN ISO 11810:2015) 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 June 2016, and conflicting national standards shall be

withdrawn at the latest by June 2016.

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 11810-2:2009, EN ISO 11810-1:2009.

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.

For relationship with EU Directive, 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 11810:2015 has been approved by CEN as EN ISO 11810:2015 without any modification.

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SIST EN ISO 11810:2016
EN ISO 11810:2015 (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 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 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.

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 EN (ERs)
of Directive 93/42/EEC
The entire standard 7.1(first indent only) This standard is intended to
provide a test method that will
The entire standard 9.3
allow an evaluation of the risk
The entire standard 12.7.5 of laser induced flammability
and temperature increase
associated with the use of a
surgical drapes during laser
surgery as part of the risk
assessment as set out in these
essential requirements.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling

within the scope of this standard.
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SIST EN ISO 11810:2016
INTERNATIONAL ISO
STANDARD 11810
Second edition
2015-12-15
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
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 — Inflammation
principale, pénétration et inflammation secondaire
Reference number
ISO 11810:2015(E)
ISO 2015
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SIST EN ISO 11810:2016
ISO 11810:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 11810:2016
ISO 11810:2015(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 ................................................................................................................................................................................... 5

6.3 Specimen holder .................................................................................................................................................................................... 5

6.4 Laser system ............................................................................................................................................................................................. 9

6.4.1 Laser ........................................................................................................................................................................................... 9

6.4.2 Power meter ........................................................................................................................................................................ 9

6.5 Gas supply system ................................................................................................................................................................................ 9

6.6 Environment ............................................................................................................................................................................................. 9

6.6.1 Ambient air conditions ............................................................................................................................................... 9

6.6.2 Oxygen enriched atmospheres ............................................................................................................................ 9

6.7 Smoke evacuation device ............................................................................................................................................................10

7 Reagents and materials ..............................................................................................................................................................................10

8 Preparation of specimens ........................................................................................................................................................................10

8.1 Sampling ....................................................................................................................................................................................................10

8.1.1 Single use products .....................................................................................................................................................10

8.1.2 Reusable products .......................................................................................................................................................10

8.2 Specimens ................................................................................................................................................................................................10

8.3 Quantities .................................................................................................................................................................................................10

8.4 Conditioning ...........................................................................................................................................................................................10

9 Preparation of apparatus .........................................................................................................................................................................11

10 Test methods ..........................................................................................................................................................................................................11

10.1 General conditions ............................................................................................................................................................................11

10.2 Primary ignition and penetration ........................................................................................................................................11

10.2.1 Principle ...............................................................................................................................................................................11

10.2.2 Testing procedure ........................................................................................................................................................14

10.3 Secondary ignition ............................................................................................................................................................................15

10.3.1 Principle ...............................................................................................................................................................................15

10.3.2 Testing procedure ........................................................................................................................................................16

11 Classification .........................................................................................................................................................................................................18

11.1 General ........................................................................................................................................................................................................18

11.2 Laser-induced primary ignition (I) ....................................................................................................................................18

11.3 Resistance to laser penetration (P) ....................................................................................................................................18

11.4 Laser-induced secondary ignition (SI) ............................................................................................................................18

12 Test report ................................................................................................................................................................................................................19

Bibliography .............................................................................................................................................................................................................................20

© ISO 2015 – All rights reserved iii
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SIST EN ISO 11810:2016
ISO 11810:2015(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 on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 9,

Electro-optical systems.

This second edition cancels and replaces ISO 11810-1:2005 and ISO 11810-2:2007 which have been

technically revised.
iv © ISO 2015 – All rights reserved
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SIST EN ISO 11810:2016
ISO 11810:2015(E)
Introduction

Some laser applications in medicine can 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 surgical 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 can have other risks but they can 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 International Standard 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 can

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 might need to be tested.

CO lasers can induce the most challenging conditions of all medical lasers. Ignition/flammability tests

and penetration tests can reveal 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 the laser for this International Standard.

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 patient-protective

cover should be tested at the wavelengths for which it is intended to be used. If tested using other

wavelengths, it is necessary to explicitly state the power settings and modes of delivery.

The results from this International Standard should not be applied to other wavelengths and

temporal formats.

The performance of laser-resistant surgical drapes or other patient-protective covers can be changed

when used in combination rather than individually.
© ISO 2015 – All rights reserved v
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SIST EN ISO 11810:2016
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SIST EN ISO 11810:2016
INTERNATIONAL STANDARD ISO 11810:2015(E)
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

CAUTION — This test method can involve hazardous materials, operations and equipment.

This International Standard 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

International Standard to establish appropriate safety and health practices and to determine

the applicability of regulatory limitations prior to use.
1 Scope

This International Standard 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 International Standard 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 International Standard to

serve as a general fire safety specification, and as such, this International Standard does not cover other

sources of ignition.

All materials reflect portions of the beam and it is necessary for the user to decide whether specular

reflectance can be a hazard. This measurement, however, is not covered in this International Standard.

The test procedure can be used to assess the laser induced flammability properties of non-laser-

resistant items

NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape

and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective

cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it

is necessary to explicitly state the power settings and modes of delivery.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 11145, Optics and photonics — 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 — Part 1: Stigmatic and simple astigmatic beams
ISO 80000-4, Quantities and units — Part 4: Mechanics

IEC 60825-1, Safety of laser products — Part 1: Equipment classification and requirements

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2015 – All rights reserved 1
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SIST EN ISO 11810:2016
ISO 11810:2015(E)
3.1
afterflame

persistence of flaming of a material, under specified test conditions, after the ignition source has been

removed
3.2
afterflame time

length of time for which a material continues to flame, under specified test conditions, after the ignition

source has been removed
3.3
afterglow

persistence of glowing of a material, under specified test conditions, after cessation of flaming or, if no

flaming occurs, after the ignition source has been removed
3.4
afterglow time

time during which a material continues to glow, under specified test conditions, after cessation of

flaming or, if no flaming occurs, after the ignition source has been removed
3.5
beam diameter

diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % of the total

beam power
3.6
beam cross-sectional area
smallest area containing 95 % of the total beam power
Note 1 to entry: Adapted from ISO 11145:2006, 3.2.1.
3.7
combustion

any continuing burning process that occurs in or on the specimen caused by a chemical process of

oxidation with the liberation of heat
EXAMPLE Flame, smouldering, rapid evolution of smoke.
3.8
damage

any change, other than combustion, which can affect the safety of the patient or efficacy of the product

due to increasing the risk of ignition
EXAMPLE Local heating, melting, creation of holes, pyrolysis.
3.9
flammable
subject to ignition and flaming combustion
3.10
ignition
creation of combustion induced by the delivery of power
3.11
laser resistance

measure of the ability of a material to withstand laser power without ignition or damage

2 © ISO 2015 – All rights reserved
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SIST EN ISO 11810:2016
ISO 11810:2015(E)
3.12
melting behaviour

softening of a material under the influence of heat (including shrinking, dripping and burning of molten

material, etc.)
3.13
patient-protective cover
material, other than a surgical drape, intended to protect a patient
3.14
penetration resistance
ability of a material to prevent the passage of laser energy
3.15
product

finished medical device (surgical drape or other patient-protective cover) that can be composed of one

or more homogeneous materials (samples)
3.16
reusable product
product intended to be laundered and re-sterilized for multiple use
3.17
secondary ignition

ignition of a specimen by an underlying material caused to burn by a laser beam transmitted

through the specimen
3.18
single use
product intended to be used once and then discarded
3.19
surgical drape
material intended to be draped over a patient during surgery
3.20
thermal resistance
ability of a material to resist conduction of heat
4 Principle

WARNING — This test method can result in a rocket-like fire involving the surgical drape. Such a

fire can produce intense heat and light and toxic gases.

To simulate worst-case conditions, the material is exposed to laser power of known characteristics in

an environment of up to 98 % ± 2 % oxygen.
5 Significance and use of the test

5.1 This International Standard describes a uniform and repeatable test method for measuring the

primary ignition, penetration, flame spread and secondary ignition of surgical drapes and other patient-

protective covers. Variables involved in laser ignition have been fixed in order to establish a basis for

comparison. This test method can be used to compare differing types and designs.

5.2 A large number and range of variables is involved in ignition of surgical drapes. A change in one

variable can affect the outcome of the test. Caution should be exercised, since the direct applicability of

the results of thi
...