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【英文标准名称】:StandardPracticeforTestingforWholeComplementActivationinSerumbySolidMaterials
【原文标准名称】:用固体材料测试血浆中整个活性的标准实施规程
【标准号】:ASTMF1984-1999(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;bloodcompatibility;wholecomplementtesting;Bloodcompatibility;Complementactivation;Implantablesurgicalmaterials/applications;invitroEvaluation;Wholecomplementactivation;Biocompatibility
【摘要】:p>Inappropriateactivationofcomplementbyblood-contactingmedicaldevicesmayhaveseriousacuteorchroniceffectsonthehost.Thispracticeisusefulasasimple,inexpensivescreeningmethodfordeterminingfunctionalwholecomplementactivationbysolidmaterialsinvitro.Thispracticeiscomposedoftwoparts.InPartA(Section11),humanserumisexposedtoasolidmaterial.Complementmaybedepletedbytheclassicaloralternativepathways.Inprinciple,nonspecificbindingofcertaincomplementcomponentsalsomayoccur.Thealternativepathwaycandepletelateractingcomponentscommontobothpathways,thatiscomponentsotherthanC1,C4,andC3(1).InPartB(Section12),complementactivityremainingintheserumafterexposuretothetestmaterialisassayedbyclassicalpathway-mediatedlysisofsensitizedRBC.Assessmentofinvitrowholecomplementactivation,asdescribedhere,providesonemethodforpredictingpotentialcomplementactivationbymedicalmaterialsintendedforclinicalapplicationinhumanswhenthematerialcontactstheblood.Othertestmethodsforcomplementactivationareavailable,includingassaysforspecificcomplementcomponentsandtheirsplitproducts(seeX1.3andX1.4).Thisinvitrotestmethodissuitableforadoptioninspecificationsandstandardsforscreeningsolidmaterialsforuseintheconstructionofmedicaldevicesintendedtobeimplantedinthehumanbodyorplacedincontactwithhumanblood.1.1Thispracticeprovidesaprotocolforrapid,invitroscreeningforwholecomplementactivatingpropertiesofsolidmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrowholecomplementactivatingpropertiesofsolidmaterialsintendedforuseincontactwithblood.Forthispractice,thewordsx201C;serumx201D;andx201C;complementx201D;areusedinterchangeably(mostbiologicalsupplyhousesusethesewordssynonymouslyinreferencetoserumusedasasourceofcomplement).1.3Thispracticeconsistsoftwoproceduralparts.ProcedureAdescribesexposureofsolidmaterialstoastandardlotofhumanserum,usinga0.1-mLserum/13x100-mmdisposabletesttube.Celluloseacetatepowdersandfibersareusedasexamplesoftestmaterials.ProcedureBdescribesassayingtheexposedserumforsignificantfunctionalwholecomplementdepletionascomparedtocontrolsamples.1.4Thispracticedoesnotaddressfunction,elaboration,ordepletionofindividualcomplementcomponents,nordoesitaddresstheuseofplasmaasasourceofcomplement.1.5Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforotheraspectsofbiocompatibility.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.
【中国标准分类号】:C05
【国际标准分类号】:11_040_01
【页数】:5P.;A4
【正文语种】:英语


【英文标准名称】:Implantsforsurgery-Metallicmaterials-Part9:Wroughthighnitrogenstainlesssteel(ISO5832-9:2007);EnglishversionofDINISO5832-9:2008-12
【原文标准名称】:外科植入物.金属材料.第9部分:锻造高氮不锈钢(ISO5832-9-2007).英文版本DINISO5832-9-2008
【标准号】:DINISO5832-9-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-12
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:化学成分;耐腐蚀性;纯度;尺寸;断裂伸长;精密机械;锻造的;锻造;粒度;植入物(外科);仪器装置;浇桶分析;材料;材料规范;机械性能;医疗设备;医学科学;金属的;金属材料;金属;微观结构;产品;性能;不锈钢;状态;钢;材料强度;外科学;外科设备;外科植入物;外科器械;拉伸强度;测试;锻制品
【英文主题词】:Chemicalcomposition;Corrosionresistance;Degreeofpurity;Dimensions;Elongationatfracture;Finemechanics;Forged;Forging;Grainsize;Implants(surgical);Instrumentation;Ladleanalysis;Materials;Materialsspecification;Mechanicalproperties;Medicalequipment;Medicalsciences;Metallic;Metallicmaterials;Metals;Microstructure;Products;Properties;Stainlesssteels;Status;Steels;Strengthofmaterials;Surgery;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Tensilestrength;Testing;Wroughtproducts
【摘要】:ThispartofISO5832specifiesthecharacteristicsof,andcorrespondingtestmethodsfor,wroughtstainlesssteelcontainingamassfractionof0,25%to0,50%nitrogenforuseinthemanufactureofsurgicalimplantsforwhichhighlevelsofstrengthandcorrosionresistancearerequired.NOTE1ThemechanicalpropertiesofasampleobtainedfromafinishedproductmadeofthisalloycandifferfromthosespecifiedinthispartofISO5832.NOTE2RequirementsforotherstainlesssteelsforimplantsforsurgerycanbefoundinISO5832-1.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40;77_140_20
【页数】:9P.;A4
【正文语种】:英语