EN 13795-2011 en Surgical drapes gowns and clean air suits used as medical devices for patients clinical staff and equipment - General requirements for manufacturers processors and.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 13795:2011Surgical drapes, gowns and clean air suits, used asmedical devices for patients,clinical staff and equipment General requirements formanufacturers, processorsand

2、products, test methods,performance requirements and performance levelsBS EN 13795:2011+A1: 3BS EN 13795:2011+A1:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 13795:2011+A1:2013. It supersedes BS EN 13795:2011, which will be withdrawn on 31 August 2013.The

3、 start and finish of text introduced or altered by amendment isindicated in the text by tags. Tags indicating changes to CEN textcarry the number of the CEN amendment. For example, text alteredby CEN amendment A1 is indicated by .The UK participation in its preparation was entrusted by Technical Com

4、mittee CH/205, Non-active medical devices, toSubcommittee CH/205/1, Medical textiles.A list of organizations represented on this subcommittee canbe obtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for i

5、ts correctapplication. The British Standards Institution 2013.Published by BSI Standards Limited 2013ISBN 978 0 580 82249 0ICS 11.140Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and St

6、rategy Committee on 31 March 2011.Amendments/corrigenda issued since publicationDate Text affected30 April 2013 Implementation of CEN amendment A1:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13795:2011+A1 February 2013 ICS 11.140 Supersedes EN 13795:2011 English Version Surgical drapes,

7、 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 Champs chirurgicaux, casaques et tenues de bloc, utiliss en tant que disposi

8、tifs 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 Operationsabdecktcher, -mntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte fr Patienten, Klinikpe

9、rsonal und Gerte - Allgemeine Anforderungen fr Hersteller, Wiederaufbereiter und Produkte, Prfverfahren und Gebrauchsanforderungen This European Standard was approved by CEN on 5 February 2011 and includes Amendment 1 approved by CEN on 8 January 2013. CEN members are bound to comply with the CEN/CE

10、NELEC 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-CENELEC Management Centre

11、 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-CENELEC Management Centre has the same status as the o

12、fficial versions. CEN members are the national standards bodies of 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, Netherlan

13、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitat

14、ion 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 5 2 Normative references 5 3 Terms and definitions .5 4 Performance requirements .8 5 Testing . 11 6 Manufactur

15、ing 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 the previous edition 13 Annex B (normative) Test methods 15 Annex C (informative) Prevention of infection in t

16、he operating room 17 Annex D (informative) Information on further characteristics . 18 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices“ . 20 Bibliography . 22 BS EN 13795:2011+A1:2013EN 13795:2011+A1:2013

17、 (E)EN 13795:2011+A1:2013 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 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

18、A (informative) Details of significant changes between this European Standard and 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

19、) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices“ . 20 Bibliography . 22 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 device

20、s”, 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 August 2013, and conflicting national standards shall be withdrawn at the latest by August 2013. Attent

21、ion is drawn to the possibility that some of the elements of 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

22、 on 2013-01-08. 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. For relationship with EU Directive(s), see informative

23、 Annex ZA, which is an integral part of this document. Annex 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 th

24、e following countries are bound to implement this European Standard: 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, Netherl

25、ands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13795:2011+A1:2013EN 13795:2011+A1:2013 (E)EN 13795:2011+A1:2013 (E) 4 Introduction The transmission of infective agents during invasive surgical procedures can occur in seve

26、ral ways (see informative Annex C). Surgical drapes, including the intended use as a sterile 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).

27、The performance required of coverings for patients, clinical staff and equipment varies 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 us

28、e of surgical gowns with resistance to the penetration of liquids can also diminish the 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 produc

29、t characteristics and performance requirements. It focuses on Essential Requirements arising 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

30、 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. BS EN 13795:2011+A1:2013EN 13795:2011+A1:2013 (E)EN 13795:2011+A1:2013 (E) 4 Intro

31、duction 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 sterile field, surgical gowns and clean air suits are used to minimize the spread of infective agents to and from pat

32、ients 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 with, for example, the type and duration of the procedure, the degree of wetness of the operation field, the degre

33、e 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 risk to the operating staff from infective agents carried in blood or body fluids. EN 13795 is intended to assist

34、the communication between users, manufacturers and third parties with regard to material or product characteristics and performance requirements. It focuses on Essential Requirements arising from the Medical Device Directive 93/42/EEC which are applicable to surgical drapes, gowns and clean air suit

35、s. 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 13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout the

36、ir useful life. 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 usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This European Stand

37、ard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical

38、 and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable

39、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 EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards. 2

40、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 20811, Textiles Determina

41、tion of resistance to water penetration Hydrostatic pressure test EN 29073-3, Textiles Test methods for nonwovens Part 3: Determination of tensile strength and elongation EN ISO 139, Textiles Standard atmospheres for conditioning and testing (ISO 139:2005) EN ISO 9073-10, Textiles Test methods for n

42、onwovens 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 methods Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 13938-1, Textiles Bursting properties

43、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 air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial

44、 penetration (ISO 22610:2006) EN ISO 22612, Clothing for protection against infectious agents Test method for resistance to dry microbial penetration (ISO 22612:2005) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 cfu (colony forming unit) u

45、nit by which the culturable number of microorganisms is expressed NOTE The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium. BS EN 13795:2011+A1:2013EN 13795:2011+A1:2013 (E)EN 13795:2011+A1:2013 (E) 6 3.2 clean air suit

46、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 infection NOTE Unlike the suit usually worn in the operating room, the clean air suit is designed to reduce the

47、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 cleanliness microbial freedom from population of viable micro-organisms on a product and/or a package NOTE In pra

48、ctical 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 not generated by mechanical impact 3.4 critical product area product area with a greater probability to be in

49、volved 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 binding 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 the wound 3.8 linting release