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

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.

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 blocs, utilisés comme dispositifs médicaux, pour les patients, le personnel médical 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 a 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 a l'heure actuelle il n'existe aucune méthode d'essai appropriée concernant l'adhésion a 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: 28-Feb-2005
• 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 13795-2:2004 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

Relations

• Consolidated By: 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
• Effective Date: 18-Jan-2023
• Consolidated By: 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
• Effective Date: 19-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
• Consolidated By: 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
• Effective Date: 01-Nov-2009
• Amended By: SIST EN 13795-2:2005/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
• Effective Date: 01-Apr-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 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



SIST EN 13795-2:2005



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



EN 13795-2:2004 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Testing requirements.6 4.1 General.6 4.2 Atmospheres for conditioning and testing.6 5 Test methods.6 5.1 Test method for evaluation of cleanliness – microbial.6 5.2 Test method for evaluation of cleanliness – particulate matter.6 5.3 Test method for evaluation of linting.7 5.4 Test method for evaluation of resistance to liquid penetration.7 5.5 Test method for evaluation of bursting strength in dry and wet state.7 5.6 Test method for evaluation of tensile strength in dry and wet state.7 5.7 Test methods for evaluation of liquid control.7 5.8 Test method for evaluation of resistance to dry microbial penetration.8 5.9 Test method for evaluation of resistance to wet microbial penetration.8 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.9 Bibliography.10 SIST EN 13795-2:2005



EN 13795-2:2004 (E) 3 Foreword This document (EN 13795-2:2004) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by BSI. 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 May 2005, and conflicting national standards shall be withdrawn at the latest by May 2005. 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, 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. SIST EN 13795-2:2005



EN 13795-2:2004 (E) 4 Introduction 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 document. NOTE For more information on products which are either included or not included in this document, refer to EN 13795-1. The EN 13795 series of European Standards, together with EN ISO 22610 and EN ISO 22612, is intended to assist the communication between users, manufacturers and third party verifiers with regard to material or product characteristics. It focuses on relevant Essential Requirements arising from the Medical Device Directive 93/42/EEC. The general requirements and guidance in EN 13795-1 are expected to be of help to manufacturers, test houses and users when designing, processing, assessing and selecting products. It is the intention of EN 13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout their useful life. SIST EN 13795-2:2005



EN 13795-2:2004 (E) 5 1 Scope 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 metho
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