DIN 65202-1987 航空和航天.弹性体O型圈.尺寸

上一篇: DIN 65178 T.5-1987 航空和航天.液态或气态介质的管道设计和安装.软管管道.结构和安装
下一篇: DIN 5587 T.3-1987 有轨车辆用压缩空气装置.风挡清洁装置.操作阀

【英文标准名称】:StandardSpecificationforImplantablePolytetrafluoroethylene(PTFE)Sheet,Tube,andRodShapesFabricatedfromGranularMoldingPowders
【原文标准名称】:用颗粒成型粉末制成薄板、管及杆状的可植入聚四氟乙烯聚合物的标准规范
【标准号】:ASTMF754-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:
【英文主题词】:perfluorocarbon;polytetrafluoroethylene;PTFE;surgicalimplant;Implantablesurgicalmaterials/applications;Plasticsurgicaldevices/applications--specifications;Polymers--surgicalapplications(specifications);PTFE(polytetrafluoroethylene)--surgica
【摘要】:FabricatedPTFEmeetingtherequirementsofthisspecificationcanbeexpectedtoexhibitconsistentandreproduciblechemical,physical,andbiologicalproperties.Thisspecificationprovidesananalyticmethodtoextractorganiccontaminantsfromfabricatedconfigurations,whichincludesalimittothepresenceofresidualadulterants,additives,orprocessingaids.Thisspecificationaddressesthecharacteristicsofvirginrawgranularmoldingpowdersobtainedfromresinmanufacturersandusedforproducingimplantconfigurations.1.1Thisspecificationdescribesthephysical,chemical,andmechanicalperformancerequirementsforpolytetrafluoroethylene(PTFE)pre-fabricatedbycompressionmoldingorextrusionintosheet,tube,androdshapeswhichmaybeusedforimplantproducts.1.2PTFEisahighmolecularweightstraightchainmemberofthegenericclassofperfluorocarbon(containingonlytheelementsfluorineandcarbon)polymers.1.3Perfluorocarbonhighpolymersexhibitextraordinarythermalandchemicalstabilityanddonotrequirestabilizingadditivesofanykind.1.4Thisspecificationappliestoprimarilyvoid-freemoldedorextrudedPTFEshapesformedfromgranularmoldingpowders.Thisspecificationdoesnotapplytoshapesformedfromx201C;finepowderx201D;resinsbylubricatedpasteextrusion,whichincludesexpandedPTFE.1.5Thisspecificationdoesnotapplytospecificsurgicalimplantproducts,includingtheirpackaging,sterilization,ormaterialboicompatibilityand/orsuitabilityforaparticularend-useapplication.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G33
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语