ASTM_F_2313_-_10.pdf

Designation:F231310Standard Specification forPoly(glycolide)and Poly(glycolide-co-lactide)Resins forSurgical Implants with Mole Fractions Greater Than orEqual to 70%Glycolide1This standard is issued under the fixed designation F2313;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 specification covers both virgin poly(glycolide)homopolymer and poly(glycolide-co-lactide)copolymer resinsintended for use in surgical implants.The poly(glycolide-co-lactide)copolymers covered by this specification possessnominal mole fractions greater than or equal to 70%glycolide(65.3%in mass fraction).This specification is also applicableto lactide-co-glycolide copolymers that possess glycolide seg-ments sufficient in size to deliver potential for glycolide basedcrystallization,thereby requiring fluorinated solvents for com-plete dissolution under room temperature conditions.1.2 Since poly(glycolide)is commonly abbreviated as PGAfor poly(glycolic acid)and poly(lactide)is commonly abbre-viated as PLA for poly(lactic acid),these polymers are com-monly referred to as PGA,PLA,and PLA:PGA resins for thehydrolytic byproducts to which they respectively degrade.PLAis a term that carries no stereoisomeric specificity and thereforeencompasses both the amorphous atactic/syndiotacticDL-lactide-based polymers and copolymers as well as the isotacticD-PLA andL-PLA moieties,each of which carries potential forcrystallization.1.3 This specification is specifically not applicable to amor-phous poly(lactide-co-glycolide)or poly(lactide)-based resinsable to be fully solvated at 30C by either methylene chloride(dichloromethane)or chloroform(trichloromethane),whichare covered in Specification F2579 and typically possess molarglycolide levels of 50%or less.This specification is notapplicable to lactide-based polymers or copolymers that pos-sess isotactic polymeric segments sufficient in size to carrypotential for lactide-based crystallization,which are coveredby Specification F1925 and typically possess nominal molefractions that equal or exceed 50%L-lactide.1.4 This specification addresses material characteristics ofboth virgin poly(glycolide)and poly(70%glycolide-co-lactide)resins intended for use in surgical implants and doesnot apply to packaged and sterilized finished implants fabri-cated from these materials.1.5 As with any material,some characteristics may bealtered by processing techniques(such as molding,extrusion,machining,assembly,sterilization,etc.)required for the pro-duction of a specific part or device.Therefore,properties offabricated forms of this resin should be evaluated indepen-dently using appropriate test methods to assure safety andefficacy.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 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:2D1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD2857 Practice for Dilute Solution Viscosity of PolymersD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-Exclusion ChromatographyD4603 Test Method for Determining Inherent Viscosity ofPoly(Ethylene Terephthalate)(PET)by Glass CapillaryViscometerE386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance(NMR)Spec-troscopy1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Dec.1,2010.Published January 2011.Originallyapproved in 2003.Last previous edition approved in 2008 as F2313 081.DOI:10.1520/F2313-10.2For 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 E473 Terminology Relating to Thermal Analysis and Rhe-ologyE793 Test Method for Enthalpies of Fusion and Crystalliza-tion by Differential Scanning CalorimetryE794 Test Method for MeltingAnd Crystallization Tempera-tures By Thermal AnalysisE967 Test Method for Temperature Calibration of Differen