ASTM F1185-2003(2009) 外科植入物用羟基磷灰石构成的标准规范

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【英文标准名称】:StandardSpecificationforCompositionofHydroxylapatiteforSurgicalImplants
【原文标准名称】:外科植入物用羟基磷灰石构成的标准规范
【标准号】:ASTMF1185-2003(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:F04.13
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bioceramic;bonegraft;hydroxylapatite(HA);hydroxyapatite;tricalciumphosphate(TCP);whitlockite;Boneimplantmaterials/applications--specifications;Ceramicsurgicalmaterials/applications--specifications;Hydroxylapatite(HA);Orthopaedicmedi
【摘要】:1.1Thisspecificationcoverschemicalandcrystallographicrequirementsforhydroxylapatiteintendedforsurgicalimplants.Foramaterialtobecalledhydroxylapatite,itmustconformtothisspecification.(SeeAppendixX1.)1.2Thebiologicalresponsetohydroxylapatiteinsofttissueandbonehasbeencharacterizedbyahistoryofclinicaluse(1-3)andbylaboratorystudies(4-6).1.3Thisspecificationincludespowder,particulate,andformsintendedforuseassurgicalimplants,componentsofsurgicalimplants,orasrawmaterialsformanufacturingprocessessuchasthermalspraycoating,electrophoreticdeposition,physicalvapordeposition,andsoforth.1.4Thisspecificationspecificallyexcludeshydroxylapatitecoatings,amorphouscalciumphosphate,ceramic-glasses,tribasiccalciumphosphate,whitlockite,andalpha-andbeta-tricalciumphosphate.(SeeSpecificationF1088.)1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,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