【英文标准名称】:StandardGuideforAssessmentofSurfaceTextureofNon-PorousBiomaterialsinTwoDimensions
【原文标准名称】:在二维对非渗透生物材料表面纹理评测的标准指南
【标准号】:ASTMF2791-2009
【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】:F04.42
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:biomaterial;characterization;opticalinstrument;non-porous;profile;roughness;stylusinstrument;surfacetexture;waviness
【摘要】:Thetermx201C;surfacetexturex201D;isusedtodescribethelocaldeviationsofasurfacefromanidealshape.Surfacetextureusuallyconsistsoflongwavelengthrepetitivefeaturesthatoccurasresultsofchatter,vibration,orheattreatmentsduringthemanufactureofimplants.Shortwavelengthfeaturessuperimposedonthelongwavelengthfeaturesofthesurface,whicharisefrompolishingoretchingoftheimplant,arereferredtoasroughness.ThisguideprovidesanoverviewoftechniquesthatareavailableformeasuringthesurfaceintermsofCartesiancoordinatesandtheparametersusedtodescribesurfacetexture.Itisimportanttoappreciatethatitisnotpossibletomeasuresurfacetextureperse,buttoderivevaluesforparametersthatcanbeusedtodescribeit.1.1Thisguidedescribessomeofthemorecommonmethodsthatareavailableformeasuringthetopographicalfeaturesofasurfaceandprovidesanoverviewoftheparametersthatareusedtoquantifythem.Beingabletoreliablyderiveasetofparametersthatdescribethetextureofbiomaterialsurfacesisakeyaspectinthemanufactureofsafeandeffectiveimplantablemedicaldevicesthathavethepotentialtotriggeranadversebiologicalreactioninsitu.1.2Thisguideisnotintendedtoapplytoporousstructureswithaverageporedimensionsinexcessofapproximately50nm(0.05x03BC;m).1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A20;A29
【国际标准分类号】:17_040_20
【页数】:9P.;A4
【正文语种】:英语