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)

ISO 11810-1:2005 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 ISO 11810-1:2005 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 ISO 11810-1:2005 to serve as a general fire safety specification, and as such, this standard 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 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)

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: 14-Apr-2009
• Withdrawal Date: 22-Dec-2015
• 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: 9960 - Withdrawal effective - Withdrawal
• 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 11810-1:2009 - 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: 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
• Replaced By: 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)
• Effective Date: 30-Dec-2015

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 th
...