ASTM F2313-2010 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide《用.pdf
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1、Designation: F2313 10Standard 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 t
2、he 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(glycol
3、ide)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 app
4、licableto 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
5、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
6、 thereforeencompasses both the amorphous atactic/syndiotactic DL-lactide-based polymers and copolymers as well as the isotacticD-PLA and L-PLA moieties, each of which carries potential forcrystallization.1.3 This specification is specifically not applicable to amor-phous poly(lactide-co-glycolide) o
7、r 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 polym
8、ers 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 chara
9、cteristics 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 techniq
10、ues (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 st
11、ated 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 a
12、nd 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 T
13、emperatures 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 Viscosit
14、y ofPoly(Ethylene Terephthalate) (PET) by Glass CapillaryViscometerE386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectros-copyE473 Terminology Relating to Thermal Analysis and Rhe-ology1This specification is under the jurisdiction of ASTM Committee
15、F04 onMedical and Surgical Materials and Devices and 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 ref
16、erenced 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We
17、st Conshohocken, PA 19428-2959, United States.E793 Test Method for Enthalpies of Fusion and Crystalli-zation by Differential Scanning CalorimetryE794 Test Method for Melting And Crystallization Tem-peratures By Thermal AnalysisE967 Test Method for Temperature Calibration of Differen-tial Scanning Ca
18、lorimeters and Differential Thermal Ana-lyzersE968 Practice for Heat Flow Calibration of DifferentialScanning CalorimetersE1142 Terminology Relating to Thermophysical PropertiesE1252 Practice for General Techniques for Obtaining Infra-red Spectra for Qualitative AnalysisE1356 Test Method for Assignm
19、ent of the Glass TransitionTemperatures by Differential Scanning CalorimetryE1994 Practice for Use of Process Oriented AOQL andLTPD Sampling PlansF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF1925 Specification for Semi-Crystalline Poly(lactide)Polymer and Co
20、polymer Resins for Surgical ImplantsF2579 Specification for Amorphous Poly(lactide) andPoly(lactide-co-glycolide) Resins for Surgical Implants2.2 ANSI Standards:3ANSI/ISO/ASQ Q9000 Quality Management Systems;Fundamentals and VocabularyANSI/ISO/ASQ Q9001 Quality Management Systems; Re-quirements2.3 I
21、SO Standards:3ISO 318 Physical Chemistry and Molecular PhysicsPart8: Quantities and UnitsISO 10993 Biological Evaluation of Medical DevicesISO 11357 PlasticsDifferential Scanning Calorimetry(DSC)2.4 U. S. Pharmacopeia (USP) Standard:4USP30/NF25 United States Pharmacopeia (USP), May 2,20072.5 Other D
22、ocuments/Websites:ICH Q3C(R3) International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceu-ticals for Human Use, Quality Guideline: Impurities:Residual Solvents521 CFR 820 Code of Federal Regulations, Title 21, Part820, Quality System Regulation6NIST Special Publi
23、cation SP811 Guide for the Use of theInternational System of Units (SI)73. Terminology3.1 Definition:3.1.1 virgin polymer, nthe initially delivered form of apolymer as synthesized from its monomers and prior to anyprocessing or fabrication into a medical device.4. Materials and Manufacture4.1 All ra
24、w monomer components and other materialscontacting either the raw monomer(s) or resin product shall beof a quality suitable to allow for use of such resin in themanufacture of an implantable medical product. Such qualityincludes adequate control of particles and other potentialcontaminants that may
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