【英文标准名称】:StandardTestMethodforEvaluationoftheEnvironmentalStabilityofCalciumPhosphateGranules,FabricatedForms,andCoatings
【原文标准名称】:磷酸钙涂层的环境稳定性评价用标准试验方法
【标准号】:ASTMF1926/F1926M-2008
【标准状态】:作废
【国别】:
【发布日期】:2008
【实施或试行日期】:
【发布单位】:(US-ASTM)
【起草单位】:F04.13
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:calcium-phosphateceramic;coating;dissolutionrate;environmentalstability;
【摘要】:1.1Thistestmethodcoverscalciumphosphatecoatingsintendedforuseinsurgicalimplantapplications.1.2Aspectsofthebiologicalresponsetocalciumphosphatematerialsinsofttissueandbonehavebeenreportedfromlaboratorystudiesandclinicaluse(1-10)2.1.3Therequirementsofthisspecificationapplytocalciumphosphatecoatingssuchascalciumhydroxyapatite(seeSpecificationF1185),beta-tricalciumphosphate(seeSpecificationF1088),andbiphasicmixturesthereofwithorwithoutintentionaladditionofotherminorcomponents(60;10%).1.4Thecoating(s)shallberepresentativeofthatproducedforsale.Itshallhavebeenproducedandprocessedunderstandardmanufacturingconditions.1.5Thecoatingsmaybeappliedtoporous,nonporous,textured,andotherimplantabletopographicalsubstrateformsrepresentativeoftheend-useproduct.1.6Thecalciumphosphatecoatingmayconstitutetheonlycoatingonasubstrateorbeonemultiplecoatings.1.7Thistestmethodislimitedtothelaboratoryevaluationofthedissolutionrateofacalciumphosphatecoatings.Nocorrelationoftheresultstoinvivoperformanceisimplied.1.8Thevaluesstatedinbothinch-poundandSIunitsaretoberegardedseparatelyasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.9Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】: