【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记的标准操作规程
【标准号】:ASTMF86-2004
【标准状态】:现行
【国别】:
【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】:外科植入物;医学科学;表面;医疗设备;外科学;工艺;金属的;准备
【英文主题词】:alkalinecleaner;cleaning;electropolishing;finalinspection;marking;metalimplants;passivation;surfacetreatment
【摘要】:Thesurfacetreatmentsdocumentedinthispracticeareintendedtoimprovethecorrosionresistanceofmetallicsurgicalimplantsmanufacturedfromiron,cobalt,titanium,andtantalumbasematerials.Ironparticles,ceramicmedia,andotherforeignparticlesmaybecomesmearedoverorimbeddedintothesurfaceofimplantsduringprocessingoperationssuchasforming,machining,tumbling,beadblasting,andsoforth.Theseparticlesshouldberemovedtominimizelocalizedrustformationandsuperficialblemishes.Thevariouschemicalandelectrochemicalsurfacetreatmentsspecifiedinthispracticeareintendedtoremoveobjectionablesurfacecontaminantsandtorestoremaximumcorrosionresistancetothepassiveoxidefilm.Theneedforanadditionalimplantsurfacetreatmentsuchassecondarypassivationinnitricacidshouldbeevaluatedforlocalizedimplantsurfacesthathaveelectrochemicalorlaserproductmarkingscreatedafterthefinalsurfacetreatment.1.1Thispracticeprovidesadescriptionofsurfacecharacteristics,methodsofsurfacepreparation,andmethodsofmarkingformetallicsurgicalimplants.Markingnomenclatureisnotspecifiedinthispractice.Surfacerequirementsandmarkingmethodsincludedintheimplantspecificationshalltakeprecedenceoverrequirementslistedinthispractice,whereappropriate.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyproblems,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】: