EN 13795-2:2004+A1:2009
(Main)Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
This EN 13795-2 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.
NOTE 1 Test methods are specified by referring to a standard test method and, if necessary, specifying amendments to adapt the test method for the purpose of this document.
NOTE 2 EN 13795-2 does not cover a test method for evaluating adhesion for fixation for the purpose of wound isolation as there is no suitable test method for adhesion to human skin available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1: 2002, Annex B.
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren
Diese EN 13795-2 legt Prüfverfahren zur Bewertung der Eigenschaften von Operationsabdecktüchern,
-mänteln und Rein-Luft-Kleidung fest.
ANMERKUNG 1 Die Prüfverfahren werden durch Verweis auf ein Normprüfverfahren festgelegt und, falls erforderlich,
werden Änderungen festgelegt, um das Prüfverfahren an die Zwecke dieses Dokuments anzupassen.
ANMERKUNG 2 EN 13795-2 enthält kein Prüfverfahren zur Bewertung der Klebefähigkeit zur Fixierung zum Zweck der
Isolierung der Wunde, da gegenwärtig kein geeignetes Prüfverfahren zur Verfügung steht. Zu weiteren Informationen über
die Klebefähigkeit zur Fixierung zum Zweck der Isolierung der Wunde, siehe EN 13795-1:2002, Anhang B.
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 2 : Méthodes d'essai
La présente partie de l’EN 13795 spécifie les méthodes d’essai permettant d’évaluer les caractéristiques des champs
chirurgicaux, casaques et tenues de bloc.
NOTE 1 Les méthodes d’essai sont spécifiées par référence à une méthode d’essai normalisée et, si nécessaire,
en précisant des modifications afin d’adapter la méthode d’essai pour les besoins du présent document.
NOTE 2 L’EN 13795-2 n’aborde pas une méthode d’essai pour l’évaluation des adhésifs de fixation et d’isolation du site
opératoire, car à l’heure actuelle il n’existe aucune méthode d’essai appropriée concernant l’adhésion à la peau. Pour de plus
amples informations sur les adhésifs de fixation et d’isolation de plaies., voir l’EN 13795-1:2002, Annexe B.
Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 2. del: Preskusne metode
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: PrüfverfahrenChamps chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 2 : Méthodes d'essaiSurgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795-2:2004+A1:2009SIST EN 13795-2:2005+A1:2009en,fr,de01-november-2009SIST EN 13795-2:2005+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795-2:2004+A1
July 2009 ICS 11.140 Supersedes EN 13795-2:2004English Version
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 2: Méthodes d'essai Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren This European Standard was approved by CEN on 15 October 2004 and includes Amendment 1 approved by CEN on 13 June 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 worldwide for CEN national Members. Ref. No. EN 13795-2:2004+A1:2009: ESIST EN 13795-2:2005+A1:2009
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices"""" .9Bibliography . 10SIST EN 13795-2:2005+A1:2009
!". 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN 13795 is expected to consist of the following parts under the general title "Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment": Part 1: General requirements for manufacturers, processors and products Part 2: Test methods Part 3: Performance requirements Originally EN 13795 was also to include Part 3: Test method for resistance to dry microbial penetration and Part 4: Test method for resistance to wet microbial penetration. However, it has been decided that these parts will now be developed by the Vienna Agreement/CEN lead route in conjunction with ISO/TC 94/SC 13. As a result, what was to have been EN 13795-3 is published as EN ISO 22612 Clothing for protection against infectious agents – Test method for resistance to dry microbial penetration, what was to have been EN 13795-4 will be published as EN ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff, and equipment - Test method to determine the resistance to wet bacterial penetration (ISO/DIS 22610:2004) and what was to have been EN 13795-5 will be published as EN 13795-3. 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 United Kingdom. SIST EN 13795-2:2005+A1:2009
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