ASTM_F_2664_-_11.pdf

Designation:F266411Standard Guide forAssessing the Attachment of Cells to Biomaterial Surfacesby Physical Methods1This standard is issued under the fixed designation F2664;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 protocols that can be used tomeasure the strength of the adhesive bond that developsbetween a cell and a surface as well as the force required todetach cells that have adhered to a substrate.Controlling theinteractions of mammalian cells with surfaces is fundamentalto the development of safe and effective medical products.Thisguide does not cover methods for characterizing surfaces.Theinformation generated by these methods can be used to obtainquantitative measures of the susceptibility of surfaces to cellattachment as well as measures of the adhesion of cells to asurface.This guide also highlights the importance of cellculture history and influences of cell type.1.2 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:2D4410 Terminology for Fluvial SedimentF22 Test Method for Hydrophobic Surface Films by theWater-Break TestF2312 Terminology Relating to Tissue Engineered MedicalProductsF2603 Guide for Interpreting Images of Polymeric TissueScaffolds2.2 ISO Standards:3ISO4287 Geometrical Product Specifications(GPS)Surface Texture:Profile MethodTerms,Definitions andSurface Texture ParametersISO 13565-1 Geometrical Product Specifications(GPS)Surface Texture:Profile Method;Surfaces Having Strati-fied Functional PropertiesPart 1:Filtering and GeneralMeasurement Conditions3.Terminology3.1 Definitions:3.1.1 adhesion,na physiochemical state by which a cell iscoupled to a non-cell surface by interfacial forces,which mayconsist of covalent or ionic forces.3.1.2 biocompatibility,na material may be consideredbiocompatible if the materials perform with an appropriate hostresponse in a specific application.F23123.1.3 biomarker,nbiochemical feature or facet that can beused to measure the progress of disease or the effects oftreatment.3.1.4 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.F23123.1.5 detachment,nprocess whereby an adhered cell orgroup of cells is actively detached from a surface.3.1.6 hydrophilic,adjhaving a strong affinity for water,wettable.F223.1.7 implant,nin medicine,an object,structure,or deviceintended to reside within the body for diagnostic,prosthetic,orother therapeutic purposes.3.1.8 laminar flow,nwell-ordered,patterned flow of fluidlayers assumed to slide over one another.(See Ref(1).)43.1.9 lay,ndirection of the predominant surface pattern.ISO 13565-13.1.10 passage,nthe transfer or transplantation of cells,with or without dilution,from one culture vessel to another.Itis understood that any time cells are transferred from onevessel to another,a certain portion of the cells may be lost and,1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.43 on Cells and Tissue Engineered Constructs for TEMPs.Current edition approved April 1,2011.Published May 2011.Originallyapproved in 2007.Last previous edition approved in 2007 as F2664 07.DOI:10.1520/F2664-11.2For 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.4The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 therefore,dilution of cells,whether deliberate or not,mayoccur.This term is synonymous with the term subculture.(SeeRef(2).)3.1.11 passage number,nthe number of times the cells inthe culture have been subcultured or passaged.In descriptionsof this process,the ratio or dilution of the cells should be statedso that the relative cultural age can be ascertained.(See Ref(2).)3.1.12 Reynolds number,na dimensionless number ex-pressing the ratio of inertia forces to viscous forces in a movingfluid.The number is given by VLr/m where V,is the fluidsvelocity,L is a characteristic length or distance such as pipediameter,r is th