EN 13795-2:2004

• Abstract:

  This part of the series of EN 13795 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.; NOTE1 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 European Standard.; Test methods for evaluating resistance to dry and wet microbial penetration are specified in prEN 13795-3 and; prEN 13795-4 and therefore not included in this part. ; NOTE2 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 available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1 Annex B.

• Status: Withdrawn
• Publication Date: 23-Nov-2004
• Withdrawal Date: 14-Jul-2009
• 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: 15-Jul-2009
• Completion Date: 15-Jul-2009
• Directive: Not Harmonized93/42/EEC - 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 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

• Merged Into: 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
• Effective Date: 30-May-2009
• Amended By: 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: 22-Dec-2008
• Revised: 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: 22-Dec-2008
• Child: 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: 22-Dec-2008

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 blocs, utilisés comme dispositifs médicaux, pour les patients, le personnel médical 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 13795-2:2004SIST EN 13795-2:2005en01-marec-2005SIST EN 13795-2:2005SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13795-2November 2004ICS 11.140English versionSurgical drapes, gowns and clean air suits, used as medicaldevices for patients, clinical staff and equipment - Part 2: TestmethodsChamps chirurgicaux, casaques et tenues de blocs, utiliséscomme dispositifs médicaux, pour les patients, lepersonnel medical et les équipements - Partie 2: Méthodesd'essaiOperationsabdecktücher, -mäntel und Rein-Luft-Kleidungzur Verwendung als Medizinprodukte für Patienten,Klinikpersonal und Geräte - Teil 2: PrüfverfahrenThis European Standard was approved by CEN on 15 October 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13795-2:2004: ESIST EN 13795-2:2005

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.9 Bibliography.10 SIST EN 13795-2:2005
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