ASTM_F_1027_-_86_2012.pdf

Designation:F102786(Reapproved 2012)Standard Practice forAssessment of Tissue and Cell Compatibility of OrofacialProsthetic Materials and Devices1This standard is issued under the fixed designation F1027;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 practice describes a procedure to assess the cyto-toxic potential of materials for use in the construction ofmedical materials and devices using human excised donor(HED)tissues and their derived primary cells taken from theorofacial region.1.2 This practice may be used either directly to evaluatematerials or as a reference against which other cytotoxicitymethods may be compared.1.3 This practice is one of a series of reference methods forassessment of cytotoxic potential,employing different tech-niques.1.4 Assessment of cytotoxicity is one of several proceduresemployed in determining the biological response to a material,as recommended in Practice F748.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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Standards:2D883 Terminology Relating to PlasticsF604 Specification for Silicone Elastomers Used in MedicalApplications(Withdrawn 2001)3F703 Specification for Implantable Breast ProsthesesF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices3.Terminology3.1 Nomenclature relating to the physical,mechanical,andchemical characteristics of plastics shall be in accordance withTerminology D883.3.2 The nomenclature and glossary of terms related to tissueculturing shall conform to that of the Tissue Culture Associa-tion(1).43.3 For other definitions used in this practice,see AnnexA1.4.Summary of Practice4.1 Primary human orofacial tissue or cells and establishedhuman cell lines are cultured in Medium A3 or any mediumsupporting primary cell growth with homologous processedhuman serum or serum components in cell culture flasks orappropriate containers.The following series of cultures is setup:4.1.1 Test material placed in contact with the cell layer.NOTE1One or more replicates of 4.1.1 may be necessary.4.1.2 Primary control wherein no material contacts the celllayer.4.1.3 Positive control wherein the cell layer is contacted bya material eliciting a known cytotoxic response,such as a toxicchemical published in the Toxic Substances List(2).4.1.4 Negative control wherein the cell layer is contacted bypolystyrene used in tissue culture labware.4.2 The test culture shall be observed daily for growth andsigns of toxicity.The test shall be terminated upon theattainment of confluency.NOTE2For an established cell line cultured with Holmes alphagrowth factor(AGF),confluency is usually achieved in slightly more than5 days.NOTE3For first passage cells from human excised donor(HED)1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Oct.1,2012.Published October 2012.Originallyapproved in 1986.Last previous edition approved in 2007 as F1027 86(2007).DOI:10.1520/F1027-86R12.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4The boldface numbers in parentheses refer to the list of references at the end ofthis practice.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 cultures,confluency is usually achieved between 10 to 20 days with anupper limit of 30 days.5.Significance and Use5.1 This practice is useful for assessing the cytotoxicpotential both when evaluating new materials or formulationsfor possible use in medical applications,and as part of a qualitycontrol program for established medical devices.5.2 This practice is used for assessing the cytotoxic poten-tial of materials intended for the fabrication of inserts orimplants in the orofacial region.5.3 This practice is restricted to normal non-transformed,human orofacial tissues using cells cultured in human serumfactors and does not depend upon cells and serum fromnon-human sources.5.4 This practice