EN 13795-1:2002

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 1: Allgemeine Anforderungen für Hersteller, Aufbereiter und ProdukteChamps chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour les patients, le personnel et les équipements - Partie 1: Exigences générales pour les fabricants, les prestataires et les produitsSurgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795-1:2002SIST EN 13795-1:2003en01-marec-2003SIST EN 13795-1:2003SLOVENSKI
STANDARD



SIST EN 13795-1:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13795-1November 2002ICS 11.140English versionSurgical drapes, gowns and clean air suits, used as medicaldevices, for patients, clinical staff and equipment - Part 1:General requirements for manufacturers, processors andproductsChamps chirurgicaux, casaques et tenues de bloc, utilisésen tant que dispositifs médicaux, pour les patients, lepersonnel et les équipements - Partie 1: Exigencesgénérales pour les fabricants, les prestataires et lesproduitsOperationsabdecktücher, -mäntel und Rein-Luft-Kleidungzur Verwendung als Medizinprodukte für Patienten,Klinikpersonal und Geräte - Teil 1: AllgemeineAnforderungen für Hersteller, Aufbereiter und ProdukteThis European Standard was approved by CEN on 2 October 2002.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 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13795-1:2002 ESIST EN 13795-1:2003



EN 13795-1:2002 (E)2ContentspageForeword.3Introduction.41Scope.42Terms and definitions.43Information to be supplied by the manufacturer or processor.74Manufacturing and processing requirements.95Testing requirements.10Annex A (informative)
Comfort.11Annex B (informative)
Adhesion for fixation and wound isolation.12Annex C (informative)
Prevention of infection in the operating theatre.13Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or otherprovisions of EU Directives.14Bibliography.15SIST EN 13795-1:2003



EN 13795-1:2002 (E)3ForewordThis document EN 13795-1:2002 has been prepared by Technical Committee CEN /TC 205 "Non-active medicaldevices", 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 orby endorsement, at the latest by May 2003, and conflicting national standards shall be withdrawn at the latest byMay 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree 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.Annexes A, B and C are informative.This document includes a Bibliography.EN 13795 is expected to consist of the following parts under the general title "Surgical drapes, gowns and clean airsuits, used as medical devices, for patients, clinical staff and equipment":Part 1:General requirements for manufacturers, processors and productsPart 2:Test methodsPart 3:Performance requirements and performance levelsOriginally 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 bedeveloped by the Vienna Agreement/CEN lead route in conjunction with ISO/TC 94/SC 13. As a result, what was tohave been EN 13795-3 will be published as EN ISO 22612 Clothing for protection against infectious agents – Testmethod for resistance to penetration by biologically contaminant dust through protective clothing materials, whatwas to have been EN 13795-4 will be published as EN ISO 22610 Clothing for protection against infectious agents– Test method for determination of penetration by bacteria through protective clothing materials and what was tohave been EN 13795-5 will be published as EN 13795-3.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN 13795-1:2003



EN 13795-1:2002 (E)4IntroductionThe transmission of infective agents during invasive surgical procedures can occur in several ways (see annex C).Surgical drapes, 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 with, for example, the typeand duration of the procedure, the degree of wetness of the operation field, the degree of mechanical stress on thematerials 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 operatingstaff from blood-borne infective agents carried in blood or body fluids.The EN 13795 series of European Standards, together with EN ISO 22610 and EN ISO 22612, is intended to assistthe communication between users, manufacturers and third party verifiers with regard to material or productcharacteristics. It focuses on relevant Essential Requirements arising from the Medical Device Directive93/42/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 EN13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughouttheir useful life.1 ScopeThis standard specifies information to be supplied to users and third party verifiers, in addition to the usual labellingof medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. Thisstandard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapesand clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent thetransmission of infective agents between patients and clinical staff during surgical and other invasive procedures.Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered byEN 13795. Requirements for medical gloves are given in the EN 455 series of European Standards and packagingmaterials are covered by the EN 868 series. Requirements for surgical masks and head coverings will be specifiedin future CEN/TC 205 standards.EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods forflammability and resistance to penetration by laser radiation, together with an appropriate classification system, aregiven in EN ISO 11810. Additional essential requirements that apply to surgical clothing and drapes are covered byother European Standards.2 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.2.1clean air suitsuit intended and shown to minimize contamination of the operating wound by the wearer's skin scales carryinginfective agents via the operating room air thereby reducing the risk of wound infectionNOTEUnlike the suit usually worn in the operation room, the clean air suit is designed to reduce the operating room aircontamination by personnel.2.2cleanlinessfreedom from unwanted foreign matterSIST EN 13795-1:2003



EN 13795-1:2002 (E)5NOTESuch matter can be micro-organisms, organic residues or particulate matter.2.2.1cleanliness — microbialfreedom from population of viable micro-organisms on a product and/or a packageNOTEIn practical use microbial cleanliness is often referred to as “bioburden“.2.2.2cleanliness — particulate matterfreedom from particles that are contaminating a material and can be released but are not generated by mechanicalimpact2.3critical product areaproduct 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 gowns2.4drapeabilityability of a material to conform to a given shape or object2.5fabriccloth made from yarn or fibres by weaving, knitting and/or other types of binding or manufacture2.6fixationadhesion of a surgical drape to the patient for the purpose of wound isolationNOTESee annex B.2.7infective agentmicro-organism that has been shown to cause a wound infection or that might cause infection in a member of thesurgical team or the patient2.8lintingrelease of fibre fragments and other particles during handling and useNOTEThese fragments and particles are originally from the fabric itself.2.9manufacturernatural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before itis placed on the market under his own name, regardless of whether these operations are carried out by that personhimself or on his behalf by a third partyNOTEFrom the Medical Device Directive 93/42/EEC.2.10processornatural or legal person who processes reusable product items so that their performance complies with therequirements of this standardNOTEA processor who places a product on the market is a manufacturer in the sense of this standard.2.11resistance to liquid penetrationability of material to resist the penetration of liquid(s) from one side of the material through to the otherSIST EN 13795-1:2003



EN 13795-1:2002 (E)62.12resistance to microbial penetrationability of material(s) to withstand penetration of micro-organisms from one side through to the other2.12.1dry penetrationeffect of a combination of air movement and mechanical action by vibration on microbial penetration in drycondition2.12.2wet penetrationeffect of combination of wetness, pressure and rubbing on microbial penetration2.13reusable productproduct intended by the manufacturer to be reprocessed and reused2.14single-use productproduct intended by the manufacturer to be used for only one surgical procedure before disposal2.15surgical drapedrape covering the patient or equipment to prevent transfer of infective agents2.16surgical gowngown worn by a member of a surgical team to prevent transfer of infective agents2.17surgical proceduresurgical intervention penetrating skin or mucosa, performed by a surgical team2.17.1clean operationoperation performed on uninfected, non-traumatised tissue and in which respiratory, alimentary or genito-urinarytracts are not entered2.17.2infection-prone operationoperation where the nature of the operation or the condition of the patient is such that infection can occur withminimal contamination2.17.3invasiv
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