ASTM_F_2902_-_12.pdf

Designation:F290212Standard Guide forAssessment of Absorbable Polymeric Implants1This standard is issued under the fixed designation F2902;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 general guidelines for thechemical,physical,mechanical,biocompatibility,and preclini-cal assessments of implantable synthetic polymeric absorbabledevices.This guide also describes evaluation methods that arepotentially useful and should be considered when assessingabsorbable implants or implant components.1.2 The described evaluations may assist a manufacturer inestablishing the safety and effectiveness of an absorbableimplant device.This listing of assessment methods may also beutilized to assist in establishing substantial equivalence to anexisting commercially marketed device.However,these poly-meric material-oriented guidelines do not necessarily reflectthe total needs for any particular implant application(forexample,orthopedic,cardiovascular),which may require ad-ditional and potentially essential application-specific evalua-tions.1.3 This guide is intended to cover all forms of absorbablepolymeric components and devices,including solid(forexample,injection-molded)and porous(for example,fibrous)forms.This guide is also intended to cover devices fabricatedfrom amorphous and/or semi-crystalline absorbable polymersystems.1.4 This guide has been generated with principal emphasison the evaluation of devices formed from synthetic polymersthat degrade in vivo primarily through hydrolysis(for example,-hydroxy-polyesters).Evaluation methods suggested hereinmay or may not be applicable to implants formed frommaterials that,upon implantation,are substantially degradedthrough other mechanisms(for example,enzymatic action).1.5 This guide references and generally describes variousmeans to assess absorbable materials,components,and de-vices.The user needs to refer to specific test methods foradditional details.Additionally,some of the recommended testmethods may require modification to address the properties ofa particular device,construct,or application.1.6 Adherence to all aspects of these guidelines is notmandatory,in that assessments and tests listed within this guideare not necessarily relevant for all absorbable implant systemsand applications.1.7 Absorbable polymers used as a matrix to control the invivo release of bioactive agents(drugs,antimicrobials,and soforth)may be evaluated according to many of the methodsdescribed herein.However,additional test methods not cov-ered by this guide will likely be needed to evaluate a bioactiveagents composition,loading,release kinetics,safety,andefficacy.1.8 Composites of absorbable polymers with ceramicsand/or metals may be evaluated according to many of themethods described herein.However,additional test methodsnot covered by this guide will likely be needed to evaluate thecomposites other component(s).1.9 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.10 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:2D570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD2990 Test Methods for Tensile,Compressive,and FlexuralCreep and Creep-Rupture of Plastics1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Dec.1,2012.Published January 2013.DOI:10.1520/F290212.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 D2991 Test Method for Stress-Relaxation of Plastics(With-drawn 1990)3D3079 Test Method for Water Vapor Transmission of Flex-ible Heat-Sealed Packages for Dry ProductsD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD4404 Test Method for Determination of Pore