DIN EN 13795-2013 Surgical drapes gowns and clean air suits used as medical devices for patients clinical staff and equipment - General requirements for manufacturers processors an .pdf
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1、October 2013Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.140!%)hB“2066931www.din.deDDIN EN 13795Surgical drapes, gowns and clean air suits, used as medical devices forpatients, clinical staff and equipment General requirements for manufacturers, processors and products, testmethods, performance requirements and performance levels;English version EN 13
3、795:2011+A1:2013,English translation of DIN EN 13795:2013-10Operationsabdecktcher, -mntel und Rein-Luft-Kleidung zur Verwendung alsMedizinprodukte fr Patienten, Klinikpersonal und Gerte Allgemeine Anforderungen fr Hersteller, Wiederaufbereiter und Produkte, Prfverfahrenund Gebrauchsanforderungen;Eng
4、lische Fassung EN 13795:2011+A1:2013,Englische bersetzung von DIN EN 13795:2013-10Champs chirurgicaux, casaques et tenues de bloc, utiliss en tant que dispositifsmdicaux pour les patients, le personnel et les quipements Exigences gnrales pour les fabricants, les prestataires et les produits, mthodes
5、dessai, exigences et niveaux de performance;Version anglaise EN 13795:2011+A1:2013,Traduction anglaise de DIN EN 13795:2013-10SupersedesDIN EN 13795:2011-06www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 24 pages10.13 DIN EN 13795:2013-
6、10 2 A comma is used as the decimal marker. National foreword This document (EN 13795:2011+A1:2013) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German bodies involved in its preparation were the Normenausschuss Medizin
7、 (Medical Standards Committee) and the Normenausschuss Textil und Textilmaschinen (Textilnorm) (Textiles and Textile Machinery Standards Committee), Joint Working Committee NA 063-01-08 GA Operationstextilien. This standard contains specifications meeting the essential requirements set out in EU Dir
8、ective 93/42/EEC on medical devices. Annex A refers to EN 13795:2011-06 and the previous editions of the 13795 series. Amendments This standard differs from DIN EN 13795:2011-06 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential require
9、ments of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable me
10、dical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN 13795-1: 2003-02, 2009-10 DIN EN 13795-2: 2005-02, 2009-12 DIN EN 13795-3: 2006-08, 2009-12 DIN EN 13795: 2011-06 EUROPEAN STANDARD NORME EUROPENNE EURO
11、PISCHE NORM EN 13795:2011+A1 February 2013 ICS 11.140 Supersedes EN 13795:2011 English Version 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 r
12、equirements and performance levels Champs chirurgicaux, casaques et tenues de bloc, utiliss en tant que dispositifs mdicaux pour les patients, le personnel et les quipements - Exigences gnrales pour les fabricants, les prestataires et les produits, mthodes dessai, exigences et niveaux de performance
13、 Operationsabdecktcher, -mntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte fr Patienten, Klinikpersonal und Gerte - Allgemeine Anforderungen fr Hersteller, Wiederaufbereiter und Produkte, Prfverfahren und Gebrauchsanforderungen This European Standard was approved by CEN on 5 February 2
14、011 and includes Amendment 1 approved by CEN on 8 January 2013. 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 re
15、ferences concerning such national standards may be obtained on application to the CEN-CENELEC 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
16、CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedo
17、nia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROP
18、ISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795:2011+A1:2013: E EN 13795:2011+A1:2013 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope
19、5 2 Normative references 5 3 Terms and definitions .5 4 Performance requirements .8 5 Testing . 11 6 Manufacturing and processing requirements . 11 7 Information to be supplied by the manufacturer or processor 11 Annex A (informative) Details of significant changes between this European Standard and
20、 the previous edition 13 Annex B (normative) Test methods 15 Annex C (informative) Prevention of infection in the operating room 17 Annex D (informative) Information on further characteristics . 18 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of
21、EU Directive 93/42/EEC on Medical Devices“ . 20 Bibliography . 22 DIN EN 13795:2013-10 EN 13795:2011+A1:2013 (E) 3 Foreword This document (EN 13795:2011+A1:2013) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European S
22、tandard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn at the latest by August 2013. Attention is drawn to the possibility that some of the elements of
23、 this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document !supersedes EN 13795:2011“. This document includes Amendment 1 approved by CEN on 2013-01-08. The start and finish of text introduced or a
24、ltered 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. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Annex
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