【英文标准名称】:StandardPracticeforSurfacePreparationandMarkingofMetallicSurgicalImplants
【原文标准名称】:金属外科植入物表面制备和标志的标准实施规程
【标准号】:ASTMF86-2004(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【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】:F04.12
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:alkalinecleaner;cleaning;electropolishing;finalinspection;marking;metalimplants;passivation;surfacetreatment;Marking;Metallicsurgicalimplantmaterials--specifications;Passivationtreatments;Specimenpreparation(general);Surfacepreparat
【摘要】:Thesurfacetreatmentsdocumentedinthispracticeareintendedtoimprovethecorrosionresistanceofmetallicsurgicalimplantsmanufacturedfromiron,cobalt,titanium,andtantalumbasematerials.Ironparticles,ceramicmedia,andotherforeignparticlesmaybecomesmearedoverorimbeddedintothesurfaceofimplantsduringprocessingoperationssuchasforming,machining,tumbling,beadblasting,andsoforth.Theseparticlesshouldberemovedtominimizelocalizedrustformationandsuperficialblemishes.Thevariouschemicalandelectrochemicalsurfacetreatmentsspecifiedinthispracticeareintendedtoremoveobjectionablesurfacecontaminantsandtorestoremaximumcorrosionresistancetothepassiveoxidefilm.Theneedforanadditionalimplantsurfacetreatmentsuchassecondarypassivationinnitricacidshouldbeevaluatedforlocalizedimplantsurfacesthathaveelectrochemicalorlaserproductmarkingscreatedafterthefinalsurfacetreatment.1.1Thispracticeprovidesadescriptionofsurfacecharacteristics,methodsofsurfacepreparation,andmethodsofmarkingformetallicsurgicalimplants.Markingnomenclatureandneutralizationofendotoxinarenotspecifiedinthispractice(seeX1.3).Surfacerequirementsandmarkingmethodsincludedintheimplantspecificationshalltakeprecedenceoverrequirementslistedinthispractice,whereappropriate.1.2Thevaluesstatedininch-poundunitsaretoberegardedasstandard.ThevaluesgiveninparenthesesaremathematicalconversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:英语