SIST EN 13795-2:2005+A1:2009

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:
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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 .75.7Test methods for evaluation of liquid control .75.8Test method for evaluation of resistance to dry microbial penetration.85.9Test method for evaluation of resistance to wet microbial penetration .8Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices"""" .9Bibliography . 10SIST EN 13795-2:2005+A1:2009



EN 13795-2:2004+A1:2009 (E) 3 Foreword This document (EN 13795-2:2004+A1:2009) 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 January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-06-13. This document supersedes EN 13795-2:2004. The start and finish of text introduced or altered by amendment is indicated in the text by tags
!". 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, 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. SIST EN 13795-2:2005+A1:2009



EN 13795-2:2004+A1:2009 (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+A1:2009



EN 13795-2:2004+A1:2009 (E) 5 1 Scope This EN 13795-2 specifies test methods for evaluating characteristics of surgical drapes, gowns and
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