ASTM F1925-2009 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants《外科植入物用半结晶(交酯)聚合物和共聚物树脂的标准规范》.pdf
《ASTM F1925-2009 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants《外科植入物用半结晶(交酯)聚合物和共聚物树脂的标准规范》.pdf》由会员分享,可在线阅读,更多相关《ASTM F1925-2009 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants《外科植入物用半结晶(交酯)聚合物和共聚物树脂的标准规范》.pdf(9页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F 1925 09Standard Specification forSemi-Crystalline Poly(lactide) Polymer and CopolymerResins for Surgical Implants1This standard is issued under the fixed designation F 1925; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revi
2、sion, 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 virgin semi-crystalline poly(L-lactide) or poly(D-lactide) homopolymer res
3、ins intended for usein surgical implants. This specification also covers semi-crystalline resins of L-lactide copolymerized with other bioab-sorbable monomers including, but not limited to, glycolide,D-lactide, and DL-lactide. The poly(L-lactide) or poly(D-lactide)based homopolymers and copolymers c
4、overed by this specifi-cation possess lactide segments of sufficient length to allowpotential for their crystallization upon annealing.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 polyme
5、rs 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/syndiotactic DL-lactide based polymers and copolymers as well as t
6、he isotacticD-PLA and L-PLA moieties, each of which carries potential forcrystallization. Inclusion of stereoisomeric specificity withinthe lactic acid based acronyms results in the following:poly(L-lactide) as PLLA for poly(L-lactic acid), poly(D-lactide)as PDLA for poly(D-lactic acid), and poly(DL
7、-lactide) as PDLLAfor poly(DL-lactic acid).1.3 This specification is applicable to lactide-based poly-mers or copolymers that possess isotactic polymeric segmentssufficient in size to carry potential for lactide-based crystalli-zation. Such polymers typically possess nominal mole frac-tions that equ
8、al or exceed 50 % L-lactide. This specification isparticularly applicable to isotactic-lactide based block copoly-mers or to polymers or copolymers synthesized from combi-nations of D-lactide and L-lactide that differ by more than 1.5total mole percent (1.5 % of total moles). This specification isno
9、t applicable to lactide-co-glycolide copolymers with gly-colide mole fractions greater than or equal to 70 % (65.3 % inmass fraction), which are covered by Specification F 2313.This specification is not applicable to amorphous polymers orcopolymers synthesized from combinations of D-lactide andL-lac
10、tide that differ by less than 1.5 total mole percent (1.5 %of total moles) as covered by Specification F 2579.1.4 This specification covers virgin semi-crystallinepoly(lactide)-based resins able to be fully solvated at 30C byeither methylene chloride (dichloromethane) or chloroform(trichloromethane)
11、. This specification is not applicable tolactide:glycolide copolymers that possess glycolide segmentssufficient in size to deliver potential for glycolide-based crys-tallization, thereby requiring fluorinated solvents for completedissolution under room temperature conditions (see Specifica-tion F 23
12、13).1.5 Within this specification, semi-crystallinity within theresin is defined by the presence of a DSC (differential scanningcalorimetry) crystalline endotherm after annealing above theglass transition temperature. While other copolymeric seg-ments may also crystallize upon annealing (for example
13、,glycolide), specific characterization of crystalline structuresother than those formed by lactide are outside the scope of thisspecification.1.6 This specification addresses material characteristics ofthe virgin semi-crystalline poly(lactide) based resins intendedfor use in surgical implants and do
14、es not apply to packaged andsterilized finished implants fabricated from these materials.1.7 As with any material, some characteristics may bealtered by processing techniques (such as molding, extrusion,machining, assembly, sterilization, and so forth) required forthe production of a specific part o
15、r device. Therefore, proper-ties of fabricated forms of this resin should be evaluatedindependently using appropriate test methods to assure safetyand efficacy.1.8 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1This specificat
16、ion is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved June 1, 2009. Published August 2009. Originallyapproved in 1998. Last previous edition approved in 2
17、005 as F 1925 99 (2005).1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.1.9 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
18、 establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD 2857 Practice for Dilute Solution Viscosity of Polymers
19、D 3417 Test Method for Enthalpies of Fusion and Crystal-lization of Polymers by Differential Scanning Calorimetry(DSC)3D 3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD 3536 Test Method for Molecular Weight A
20、verages andMolecular Weight Distribution by Liquid Exclusion Chro-matography (Gel Permeation ChromatographyGPC)3D 3593 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Certain Polymers byLiquid Size-Exclusion Chromatography (Gel PermeationChromatographyGPC) Using Univers
21、al Calibration3D 4603 Test Method for Determining Inherent Viscosity ofPoly(Ethylene Terephthalate) (PET) by Glass CapillaryViscometerE 386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectros-copyE 473 Terminology Relating to Thermal Analysis and Rhe-
22、ologyE 793 Test Method for Enthalpies of Fusion and Crystalli-zation by Differential Scanning CalorimetryE 794 Test Method for Melting And Crystallization Tem-peratures By Thermal AnalysisE 967 Test Method for Temperature Calibration of Differ-ential Scanning Calorimeters and Differential ThermalAna
23、lyzersE 968 Practice for Heat Flow Calibration of DifferentialScanning CalorimetersE 1142 Terminology Relating to Thermophysical PropertiesE 1252 Practice for General Techniques for Obtaining In-frared Spectra for Qualitative AnalysisE 1356 Test Method for Assignment of the Glass TransitionTemperatu
24、res by Differential Scanning CalorimetryE 1994 Practice for Use of Process Oriented AOQL andLTPD Sampling PlansF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 2313 Specification for Poly(glycolide) andPoly(glycolide-co-lactide) Resins for Surgical Implantswit
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