iso_8536-4_2010医用输液器具--第4部分：重力输液式一次性使用输液器

ReferencenumberISO8536-4:2010(E)©ISO2010INTERNATIONALSTANDARDISO8536-4Fifthedition2010-10-01Infusionequipmentformedicaluse—Part4:Infusionsetsforsingleuse,gravityfeedMatérieldeperfusionàusagemédical—Partie4:Appareilsdeperfusionnonréutilisables,àalimentationpargravitéISO8536-4:2010(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.COPYRIGHTPROTECTEDDOCUMENT©ISO2010Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56•[e-mail]©ISO2010–AllrightsreservedISO8536-4:2010(E)©ISO2010–AllrightsreservediiiContentsPageForeword............................................................................................................................................................iv1Scope......................................................................................................................................................12Normativereferences............................................................................................................................13Generalrequirements...........................................................................................................................14Designation............................................................................................................................................44.1Infusionset............................................................................................................................................44.2Air-inletdevice.......................................................................................................................................45Materials.................................................................................................................................................46Physicalrequirements..........................................................................................................................56.1Particulatecontamination.....................................................................................................................56.2Leakage..................................................................................................................................................56.3Tensilestrength.....................................................................................................................................56.4Closure-piercingdevice........................................................................................................................56.5Air-inletdevice.......................................................................................................................................56.6Tubing.....................................................................................................................................................66.7Fluidfilter...............................................................................................................................................66.8Dripchamberanddriptube..................................................................................................................66.9Flowregulator........................................................................................................................................66.10Flowrateofinfusionfluid.....................................................................................................................66.11Injectionsite...........................................................................................................................................66.12Maleconicalfitting................................................................................................................................66.13Protectivecaps......................................................................................................................................67Chemicalrequirements...........................................................................