SIST 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)

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.

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)

Dieser Teil von ISO 11810 gilt für Einwegprodukte und wieder verwendbare gewebte Materialien und Vliesstoffe, die als Operationstücher und andere Abdeckungen zum Schutz des Patienten mit dem Anspruch auf Laserstrahlungsbeständigkeit verwendet werden.
Der Zweck dieses Teils von ISO 11810 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 dieses Teils von ISO 11810 besteht nicht darin, als allgemeine Brandsicher-heitsvorschrift zu dienen, und insofern werden andere Zündquellen von dieser Norm nicht erfasst. Sie behandelt auch nicht das Thema der durch Laser hervorgerufenen sekundären Entzündung.
Alle Materialien reflektieren Anteile des Strahls, und es ist für den Anwender erforderlich, entscheiden zu können, ob die spiegelnde Reflexion eine Gefährdung darstellen kann. Diese Messungen werden jedoch in diesem Teil von ISO 11810 nicht erfasst.

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: Inflammation primaire et pénétration (ISO 11810-1:2005)

L'ISO 11810-1:2005 s'applique aux matériaux non-réutilisables et réutilisables, ainsi qu'aux matériaux tissés et non tissés utilisés comme draps chirurgicaux ou à d'autres couvertures de protection des patients déclarés résistants au laser.
L'objectif de l'ISO 11810-1:2005 est de fournir une méthode normalisée pour soumettre à essai et classer les draps chirurgicaux et les autres couvertures de protection des patients en fonction des risques liés au laser. Un système de classification approprié est indiqué. L'ISO 11810-1:2005 n'a pas pour objet de servir de spécification générale de sécurité contre le feu et, en tant que telle, elle ne couvre pas d'autres sources d'inflammation, ni l'inflammation secondaire induite par le laser.
Tous les matériaux réfléchissent des portions du faisceau laser et il est nécessaire que l'utilisateur décide si le facteur de réflexion spéculaire peut constituer un risque. Ce mesurage n'est cependant pas couvert par l'ISO 11810-1:2005.

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)

General Information

• Status: Withdrawn
• Publication Date: 19-Apr-2009
• Withdrawal Date: 31-Jan-2016
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.99 - Other protective equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Feb-2016
• Due Date: 24-Feb-2016
• Completion Date: 01-Feb-2016
• 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: 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)

Relations

• Replaces: SIST EN 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)
• Effective Date: 01-May-2009
• Replaced By: 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)
• Effective Date: 01-Mar-2016
• Replaces: SIST EN 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)
• Effective Date: 22-Apr-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11810-1:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 11810-1:2005
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: Inflammation primaire et pénétration (ISO 11810-1:2005)
Ta slovenski standard je istoveten z: EN ISO 11810-1:2009
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 11810-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11810-1:2009

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SIST EN ISO 11810-1:2009
EUROPEAN STANDARD
EN ISO 11810-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.30; 13.340.99; 31.260 Supersedes EN ISO 11810-1:2005
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: Inflammation primaire et pénétration Entzündung und Laserdurchstrahlung (ISO 11810-1:2005)
(ISO 11810-1:2005)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11810-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11810-1:2009
EN ISO 11810-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 11810-1:2009
EN ISO 11810-1:2009 (E)
Foreword
The text of ISO 11810-1:2005 has been prepared by Technical Committee ISO/TC 172 “Optics and optical
instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11810-1:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 11810-1:2005.
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 EC Directive.
For relationship with EC 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11810-1:2005 has been approved by CEN as a EN ISO 11810-1:2009 without any
modification.
3

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SIST EN ISO 11810-1:2009
EN ISO 11810-1:2009 (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 Communities 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 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) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of EU Directive 93/42/EEC
This entire standard §§ 1; 2; 3; 4; 7.1; 9.3; 12.7.5; 13.1 Only the test method and
the classification system

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.



4

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SIST EN ISO 11810-1:2009

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 11810-1:2009
ISO 11810-1:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 11810-1:2009
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 11810-1:2009
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 11810-1:2009
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 11810-1:2009

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SIST EN ISO 11810-1:2009
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
...