EN 13795-2:2004+A1:2009

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

• Status: Withdrawn
• Publication Date: 14-Jul-2009
• Withdrawal Date: 15-Mar-2011
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 16-Mar-2011
• Completion Date: 16-Mar-2011
• 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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13795-2:2005+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

Relations

• Merged From: EN 13795-2:2004/FprA1 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
• Effective Date: 30-May-2009
• Merged From: EN 13795-2:2004 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
• Effective Date: 30-May-2009
• Replaced By: EN 13795:2011 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
• Effective Date: 15-Aug-2009

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



SIST EN 13795-2:2005+A1:2009



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



EN 13795-2:2004+A1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .54Testing requirements .64.1General .64.2Atmospheres for conditioning and testing .65Test methods .65.1Test method for evaluation of cleanliness – microbial .65.2Test method for evaluation of cleanliness – particulate matter .65.3Test method for evaluation of linting.75.4Test method for evaluation of resistance to liquid penetration .75.5Test method for evaluation of bursting strength in dry and wet state .75.6Test method for evaluation of tensile strength in dry and wet state .
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