EN 13795-3:2006

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 3: Gebrauchsanforderungen und LeistungsstufenChamps chirurgicaux, casaques et tenues de bloc utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 3 : Exigences et niveaux de performanceSurgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795-3:2006SIST EN 13795-3:2006en,fr,de01-julij-2006SIST EN 13795-3:2006SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13795-3June 2006ICS 11.140 English VersionSurgical drapes, gowns and clean air suits, used as medicaldevices for patients, clinical staff and equipment - Part 3:Performance requirements and performance levelsChamps chirurgicaux, casaques et tenues de bloc utilisésen tant que dispositifs médicaux pour les patients, lepersonnel et les équipements - Partie 3 : Exigences et seuilde performanceOperationsabdecktücher, -mäntel und Rein-Luft-Kleidungzur Verwendung als Medizinprodukte für Patienten,Klinikpersonal und Geräte - Teil 3:Gebrauchsanforderungen und LeistungsstufenThis European Standard was approved by CEN on 27 April 2006.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, Romania,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© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13795-3:2006: ESIST EN 13795-3:2006

Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Performance requirements.6 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices.10 Bibliography.11
2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13795-1, 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 EN 13795-2, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 2: Test methods EN ISO 22610, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff,
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