ASTM F1854-2009 医用植入物上多孔覆层的立体测量评价的标准试验方法

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【英文标准名称】:StandardTestMethodforStereologicalEvaluationofPorousCoatingsonMedicalImplants
【原文标准名称】:医用植入物上多孔覆层的立体测量评价的标准试验方法
【标准号】:ASTMF1854-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:coatinggradiants;metallography;porosity;porouscoatings;stereology;thickness;Meaninterceptlength;Metallicsurgicalimplantmaterials;Porosity--medical/surgicalmaterials;Stereologicalmeasurement;Thickness--surgicalimplantmaterials;Voidco
【摘要】:Allofthesetestmethodsarerecommendedforelementaryquantificationofthemorphologicalpropertiesofporouscoatingsbondedtosolidsubstrates.Thesetestmethodsmaybeusefulforcomparativeevaluationsofdifferentcoatingsordifferentlotsofthesamecoating.Withtheexceptionofusingthealternatemountingmethod,allthemethodsshouldbeperformedonthesameworkingsurfaces.Thealternatemountingmethodcanonlybeusedfor9.2and9.3.Astatisticalestimatecanbemadeofthedistributionsofthemeancoatingthicknessandthevolumepercentvoid.Noestimatecanbemadeofthedistributionofinterceptlengths.Therearelimitstotheaccuratecharacterizationofporosity,dependingonspacingbetweenthelinesinthelinegrid(orpointsinthepointgrid)andtheindividualandcumulativefieldsusedforthemeasurements.Increasingthesizeofthefields,increasingthenumberoffields,ordecreasingthegridspacingwillincreasetheaccuracyofthemeasurementsobtained.Thismethodisnotsuitableforceramiccoatingsforwhichaccuratecoatingcrosssectionscannotbeproducedusingmetallographictechniques.Thistestmethoddoesnotaddresscharacterizationofcoatingshavingathicknessoflessthan300x03BC;m.1.1Thistestmethodcoversstereologicaltestmethodsforcharacterizingthecoatingthickness,voidcontent,andmeaninterceptlengthofvariousporouscoatingsadheringtononporoussubstrates.1.2Amethodtomeasurevoidcontentandinterceptlengthatdistinctlevels(x201C;tissueinterfacegradientsx201D;)throughtheporouscoatingthicknessisoutlinedin9.4.1.3Thealternatesampleorientationmethodin8.2isnotsuitableforthetissueinterfacegradientsmethodin9.4.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:英语