ASTM_F_2791_-_15.pdf

Designation:F279115Standard Guide forAssessment of Surface Texture of Non-Porous Biomaterialsin Two Dimensions1This standard is issued under the fixed designation F2791;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes some of the more common meth-ods that are available for measuring the topographical featuresof a surface and provides an overview of the parameters thatare used to quantify them.Being able to reliably derive a set ofparameters that describe the texture of biomaterial surfaces isa key aspect in the manufacture of safe and effective implant-able medical devices that have the potential to trigger anadverse biological reaction in situ.1.2 This guide is not intended to apply to porous structureswith average pore dimensions in excess of approximately 50nm(0.05 m).1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2C813 Test Method for Hydrophobic Contamination on Glassby Contact Angle MeasurementF2312 Terminology Relating to Tissue Engineered MedicalProductsF2450 Guide for Assessing Microstructure of PolymericScaffolds for Use in Tissue-Engineered Medical ProductsF2664 Guide for Assessing the Attachment of Cells toBiomaterial Surfaces by Physical Methods2.2 Other Standards:3ISO 3274 Geometrical Product Specifications(GPS)Surface Texture:Profile MethodNominal Characteris-tics of Contact(Stylus)InstrumentsISO 4287 Geometrical Product Specifications(GPS)Surface Texture:Profile MethodTerms,Definitions andSurface Texture ParametersISO 4288 Geometrical Product Specifications(GPS)Surface Texture:Profile MethodRules and Proceduresfor the Assessment of Surface TextureISO 135651 Geometrical Product Specifications(GPS)Surface Texture:Profile MethodSurfaces Having Strati-fied Functional Properties;Filtering and General Measure-ment Conditions3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 biomaterial,nany substance(other than a drug),synthetic or natural,that can be used as a system or part of asystem that treats,augments,or replaces any tissue,organ,orfunction of the body.F26643.1.2 evaluation length,ln,nlength in the direction of thex-axis used to assess the profile under evaluation.3.1.2.1 DiscussionThe evaluation length may contain oneor more sampling lengths.ISO 42873.1.3 hydrophilic,adjhaving a strong affinity for water;wettable.3.1.3.1 DiscussionHydrophilic surfaces exhibit zero con-tact angles.C8133.1.4 hydrophobic,adjhaving little affinity for water;nonwettable.3.1.4.1 DiscussionHydrophobic surfaces exhibit contactangles appreciably greater than zero:generally greater than 45for the advancing angle.C8133.1.5 implant,na substance or object that is put in thebody as a prosthesis,or for treatment or diagnosis.F26643.1.6 lay,nthe direction of the predominant surfacepattern.ISO 1356511This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved May 1,2015.Published June 2015.Originallyapproved in 2009.Last previous edition approved in 2014 as F2791 14.DOI:10.1520/F2791-15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.7 primary profile,nthe profile after application of theshort wavelength filters.ISO 32743.1.8 profile peak,nan outwardly directed(from thematerial to the surrounding medium)portion of the assessedprofile connecting two adjacent points of the intersection of theprofile with the x-axis.ISO 42873.1.9 profile valley,nan inwardly directed(from surround-ing medium to material)portion of the assessed profileconnecting two adjacent points of the intersection of theassessed profile with the x-axis.ISO 42873.1.10 real surface,nsurface limiting the body and sepa-rating it from the surrounding medium.ISO 42873.1.11 sampling length,lr,n length in the direction of thex-axis used for identifying the irregularities characterizing theprofile under evalua