EN13795

DuPontMedicalFabricsEN13795UNDERSTANDINGTHEEUROPEANSTANDARDSURGICALGOWNS,DRAPESANDCLEANAIRSUITSBrochuremedicale-Def22/09/0613:51Page1Brochuremedicale-Def22/09/0613:51Page2INTRODUCTIONEuropeanStandardEN13795aimstoestablishrequirementsforsurgicaldrapes,gownsandcleanairsuitsusedasmedicaldevicesforpatients,clinicalstaffandequipment.DuPontseesEN13795asavitaladvancementtowardsimprovedsafetyandprotectionofpeopleandhasthereforestronglysupportedthedraftingeffortsofthetext.ItisDuPont’sintentiontofurthercontributetotheeducationandinformationdisseminationacrossthehealthcareprofessioninmattersrelatedtothisimportantStandard.Thisbookletprovideshealthcareprofessionals,medicaldevicesmanufacturersandadministratorswithuptodateinformationontheEN13795StandardanditsrelationshiptootherEuropeanlegislationinthefieldofmedicaldevices.ItalsodescribestheimplicationsoftheStandardforthedailyworkpracticesofhealthcareworkersinEurope.Brochuremedicale-Def22/09/0613:51Page3THECONTEXTOFTHEEUROPEANSTANDARDEN13795In1998,theEuropeanCommitteeforStandardization(CEN)anditsTechnicalCommittee205Non-activeMedicalDevicesreceivedamandatefromtheEuropeanCommissiontoestablishaharmonizedEuropeanStandardEN13795forsurgicalgowns,drapesandcleanairsuits.Thisbrochureintroducesthereadertotheresultsofthatwork.THESCOPEOFTHENEWSTANDARDWASDEFINEDASFOLLOWSThisStandardspecifiesinformationtobesuppliedtousersandthirdpartyverifiersinadditiontotheusuallabellingofMedicalDevicesconcerningmanufacturingandprocessingrequirements.Itgivesgeneralguidanceonthecharacteristicsofsingle-useandre-usablesurgicalgowns,surgicaldrapesandcleanairsuitsusedasmedicaldevicesforpatients,clinicalstaffandequipment.Itisintendedtopreventthetransmissionofinfectiousagentsbetweenpatientsandclinicalstaffduringsurgicalandotherinvasiveprocedures.ENHANCINGTHEMEDICALDEVICEDIRECTIVEEN13795closesthemissingtechnicallinktocompliancewiththeregulationsoftheEuropeanCouncilDirective93/42/EECthatisoftenreferredtoasMedicalDeviceDirective(MDD).TheMedicalDeviceDirectivewaspublishedin1993andbecamemandatoryinallEuropeanandEFTAcountriesin1998supersedingpriorexistingnationallegislation.MDDappliestoallmedicaldevicesanddescribestheessentialrequirementsinabroadmanner.Theessentialrequirementsregulatethedesignandconstructionofmedicaldevicesandclarifykeyparametersforensuringthatmedicaldeviceswillnotcompromisethesafetyandhealthofpatientsandhealthcareprofessionals.Theseparametersincludetheconditionsfortheirsafeuse,storage,transportandlabellingaswellasfortheirchemical,microbiologicalandphysicalproperties.EachdeviceisclassifiedasClassI,ClassIIorClassIIIdependingonitsintendedpurposeanditsassociatedrisks.ClassIcoversnon-invasivedevicessuchassurgicalgowns,drapesandcleanairsuits.ClassesIIandIIIdealwithdevicesthatbearahigherriskpotentialforpatientsandhealthcareworkers.MedicaldevicesthatcomplywiththeprovisionsoftheMedicalDevicesDirectivewillreceivetheCEmarkasthevisibleindicationtousersthatthedevicecanbesafelyusedandprovidesthecorrectlevelofprotection.Brochuremedicale-Def22/09/0613:51Page4PartTwoofthestandarddescribesthetestmethodstobeusedtoevaluatetheproductcharacteristicsindicatedinPartOne.APerformanceRequirementsmatrixdividescoveredproductsintostandardperformanceandhighperformanceclasses.Thematrixisthensubdividedintocriticalandlesscriticalproductareas.Highperformanceproductsshallbeusedforsurgicalinterventionswithahighinfectionriskduetothelengthorintensityofthesurgicalintervention.Criticalproductareasaredefinedasproductareasthataremorelikelytobeinvolvedinthetransferofinfectiousagentstoorfromawound,suchasthefrontorsleevesofasurgicalgown.Inthecaseofsurgicalgownsanddrapes,labellingofproductsputonthemarketshallclearlyindicatewhethertheproductIsastandardorhighperformanceleveldevice.Thelabellingshallfurtherincludetheindicationofcriticalandlesscriticalproductareas,asdesignedbythemanufacturer.TheEuropeanStandarddoesnotprovideanyrecommendationfortheenduserastowhichproductshallbeusedforaspecificsurgicalIntervention.Forthis,thehealthcareproviderneedstoperformariskassessmentforthesurgicalinterventioninquestionandcanrequestguidanceforthisfromhisproviderofsurgicalgownsanddrapes.PartOnedefinesthegeneralrequirementsforthedesign,processing,assessmentandselectionofproducts.Theobjectiveistoensurethesamelevelofsafetyfromsingle-useandre-usablesurgicalclothinganddrapesthroughouttheirentireusefullife.PARTTWOPARTTHREETESTMETHODS-EN13795-2PERFORMANCEREQUIREMENTANDPERFORMANCELEVEL-EN13795-3THENEWSTANDARDEN13795ThenewStandarddefinestheessentialrequirementsforsurgicalgowns,drapesandcleanairsuits.TheEuropeanStandardEN13795consistsof3separateparts.GENERALREQUIREMENTSFORMANUFACTURERS,PROCESSORSANDPRODUCTS-EN13795-1PARTONEBrochuremedicale-Def22/09/0613:51Page5TABLE1CHARACTERISTICSTOBEEVALUATEDINSURGICALGOWNSCharacteristicResistancetomicrobialpenetration–dryResistancetomicrobialpenetration–wetCleanliness–microbialCleanliness–particulatematterLintingResistancetoliquidpenetrationBurstingstrength–dryBurstingstrength–wetTensilestrength–dryTensilestrength–wetCharacteristicResis