ASTM F2695-2007 与外科植入物用α维生素E(维他命E)混合的超高分子量聚乙烯粉末的标准规范

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【英文标准名称】:StandardSpecificationforUltra-HighMolecularWeightPolyethylenePowderBlendedWithAlpha-Tocopherol(VitaminE)andFabricatedFormsforSurgicalImplantApplications
【原文标准名称】:与外科植入物用α维生素E(维他命E)混合的超高分子量聚乙烯粉末的标准规范
【标准号】:ASTMF2695-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:植入物(外科);医疗设备;医疗技术学;聚乙烯;粉末;外科学;外科植入物;维生素E;超高分子
【英文主题词】:alpha-tocopherol;fabricatedforms;powderedform;ultra-highmolecularweightpolyethylene;vitaminE
【摘要】:1.1Thisspecificationcoversultra-highmolecularweightpolyethylene(UHMWPE)powderblendedwithalpha-tocopherol(vitaminE)intendedforuseinsurgicalimplants.1.2Therequirementsofthisspecificationapplytoalpha-tocopherol-containingUHMWPEintwoforms.Oneisvirginpolymerpowderblendedwithalpha-tocopherolpriortoconsolidation(Section4).Thesecondisanyformfabricatedfromthisblended,alpha-tocopherol-containingpowderfromwhichafinishedproductissubsequentlyproduced(Section5).Thisspecificationdoesnotapplytofinishedorsemi-finishedproductsthataredopedwithvitaminEafterconsolidation.1.3Asidefromblendingwithalpha-tocopherol,theprovisionsofSpecificationsF648andD4020apply.Specialrequirementsdetailedinthisspecificationareaddedtodescribepowderscontainingalpha-tocopherolthatwillbeusedinsurgicalimplants.Thisspecificationaddressesmaterialcharacteristicsanddoesnotapplytothepackagedandsterilizedfinishedimplant.ThisspecificationalsodoesnotapplytoUHMWPEmaterialsextensivelycrosslinkedbygammaandelectronbeamsourcesofionizingradiation.1.4Thefollowingprecautionarycaveatpertainsonlytothefabricatedformsportion,Section5,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G31
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】: