SIST EN 13795-3:2006

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.
NOTE   General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, prEN ISO 22610 and EN ISO 22612.

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 3: Gebrauchsanforderungen und Leistungsstufen

Dieser Teil der Normenreihe EN 13795 legt Gebrauchsanforderungen an Operationsabdecktücher, -mäntel
und Rein-Luft-Kleidung fest.
ANMERKUNG Allgemeine Gebrauchsanforderungen für unterschiedliche Eigenschaften sind in EN 13795-1:2002,
Tabellen 1, 2 und 3 festgelegt und sollten nach EN 13795-2, EN ISO 22610 und EN ISO 22612 bewertet werden.

Champs 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 performance

La présente partie de la série des EN 13795 spécifie les exigences de performance qui s’appliquent aux champs chirurgicaux, aux casaques et aux tenues de bloc.
NOTE   Les exigences de performance générales qui s’appliquent a différentes caractéristiques sont spécifiées dans les Tableaux 1 a 3 de l’EN 13795-1:2002. Il convient d’évaluer ces caractéristiques conformément a l’EN 13795-2, a l’EN ISO 22610 et a l’EN ISO 22612.

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 3. del: Zahtevane lastnosti in zahtevane stopnje

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2006
• Withdrawal Date: 19-Aug-2009
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Aug-2009
• Due Date: 12-Sep-2009
• Completion Date: 20-Aug-2009
• 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: EN 13795-3:2006 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

Relations

• Consolidated By: SIST EN 13795-3:2006+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 19-Jan-2023
• Consolidated By: SIST EN 13795-3:2006+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 18-Jan-2023
• Child: SIST 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
• Amended By: SIST EN 13795-3:2006/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 01-Apr-2009
• Consolidated By: SIST EN 13795-3:2006+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 01-Nov-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 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



SIST EN 13795-3:2006



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



EN 13795-3:2006 (E) 2 Contents
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
SIST EN 13795-3:2006



EN 13795-3:2006 (E) 3 Foreword This document (EN 13795-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, 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 December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. 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, see informative Annex ZA, which is an integral part of this document. EN 13795 consists 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 and performance levels Attention is also drawn to the following: 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 22610:2006) EN ISO 22612 Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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. SIST EN 13795-3:2006



EN 13795-3:2006 (E) 4 Introduction The series of EN 13795 specifies requirements for single-use and reusable coverings (i. e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. General requirements for surgical drapes, gowns and clean air suits, used as medical devices, for patients clinical staff and equipment are specified in EN 13795-1. In this respect EN 13795-1 specifies the relevant characteristics to be evaluated for products covered by this European Standard. EN 13795-2 specifies test methods for evaluating these characteristics. NOTE For more information on products contained within the scope of this European Standard it is recommended to refer to EN 13795-1. SIST EN 13795-3:2006



EN 13795-3:2006 (E) 5 1 Scope This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits. NOTE General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612.
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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