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

25、 A provides details of significant changes between this European Standard and the previous edition represented by the three parts mentioned above. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European S

26、tandard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,

27、 Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 13795:2013-10 EN 13795:2011+A1:2013 (E) 4 Introduction The transmission of infective agents during invasive surgical procedures can occur in several ways (see informative Annex C). Surgical drapes, including the intended use as a ste

28、rile field, surgical gowns and clean air suits are used to minimize the spread of infective agents to and from patients operating wounds, thereby helping to prevent post-operative wound infections (see Annex C). The performance required of coverings for patients, clinical staff and equipment varies

29、with, for example, the type and duration of the procedure, the degree of wetness of the operation field, the degree of mechanical stress on the materials and the susceptibility of the patient to infection. The use of surgical gowns with resistance to the penetration of liquids can also diminish the

30、risk to the operating staff from infective agents carried in blood or body fluids. EN 13795 is intended to assist the communication between users, manufacturers and third parties with regard to material or product characteristics and performance requirements. It focuses on Essential Requirements ari

31、sing from the Medical Device Directive 93/42/EEC which are applicable to surgical drapes, gowns and clean air suits. The requirements and guidance in EN 13795 are expected to be of help to manufacturers and users when designing, processing, assessing and selecting products. It is the intention of EN

32、 13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout their useful life. DIN EN 13795:2013-10 EN 13795:2011+A1:2013 (E) 5 1 Scope This European Standard specifies information to be supplied to users and third party verifiers in addition to the

33、 usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, cli

34、nical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air s

35、uits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and E

36、N ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies.

37、 For undated references, the latest edition of the referenced document (including any amendments) applies. EN 20811, Textiles Determination of resistance to water penetration Hydrostatic pressure test EN 29073-3, Textiles Test methods for nonwovens Part 3: Determination of tensile strength and elong

38、ation EN ISO 139, Textiles Standard atmospheres for conditioning and testing (ISO 139:2005) EN ISO 9073-10, Textiles Test methods for nonwovens Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) EN ISO 11737-1:2006, Sterilization of medical devices Microbiological metho

39、ds Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 13938-1, Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) EN ISO 22610, Surgical drapes, gowns and clean

40、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

41、) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 cfu (colony forming unit) unit by which the culturable number of microorganisms is expressed NOTE The culturable number is the number of microorganisms, single cells or aggregates, able to for

42、m colonies on a solid nutrient medium. DIN EN 13795:2013-10 EN 13795:2011+A1:2013 (E) 6 3.2 clean air suit suit intended and shown to minimize contamination of the operating wound by the wearers skin scales carrying infective agents via the operating room air thereby reducing the risk of wound infec

43、tion NOTE Unlike the suit usually worn in the operating room, the clean air suit is designed to reduce the operating room air contamination by personnel. 3.3 cleanliness freedom from unwanted foreign matter NOTE Such matter can be micro-organisms, organic residues or particulate matter. 3.3.1 cleanl

44、iness microbial freedom from population of viable micro-organisms on a product and/or a package NOTE In practical use, microbial cleanliness is often referred to as bioburden. 3.3.2 cleanliness particulate matter freedom from particles that are contaminating a material and can be released but are no

45、t generated by mechanical impact 3.4 critical product area product area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns 3.5 fabric cloth made from yarn or fibres by weaving, knitting and/or other types of bi

46、nding or manufacture 3.6 infective agent micro-organism that has been shown to cause wound infections or that might cause infection in a member of the surgical team or the patient 3.7 less critical product area product area less likely to be involved in the transfer of infective agents to or from th

47、e wound 3.8 linting release of fibre fragments and other particles during handling and use NOTE These fragments and particles are originally from the fabric itself. 3.9 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it

48、 is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party NOTE For more details refer to the Medical Device Directive 93/42/EEC. DIN EN 13795:2013-10 EN 13795:2011+A1:2013 (E) 7 3.10 performance level

49、discrete standard defined to classify products according to the performance requirements of this standard NOTE With the introduction of two performance levels EN 13795 acknowledges the fact that products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress and liquid challenge throughout the surgical procedure. 3.10.1 standard performance classification addressing minimum perform