ASTM F2579-06e1
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- Standard No.
- ASTM F2579-06e1
- Release Date
- 2006
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2579-08
- Latest
- ASTM F2579-18
- Scope
1.1 This specification covers virgin poly(lactide) and poly(lactide-co-glycolide) resins able to be fully solvated at 30176;C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers covered by this specification are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50 % lactide.
1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no enantiomeric specificity and therefore also encompasses the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to d,l-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic d,l-lactide based polymers and copolymers covered by this specification.
1.3 This specification is not applicable to lactide based polymers or copolymers that possess isotactic polymeric segments sufficient in size to deliver potential for lactide based crystallization. This specification is not applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction). This specification is not applicable to block copolymers or to polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5 % of total moles).
1.4 This specification addresses material characteristics of both poly(lactide) and poly(lactide-co-glycolide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials.
1.5 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to assure safety and efficacy.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F2579-06e1 Referenced Document
- ANSI/ISO/ASQ Q9000 Quality Management Systems - Fundamentals and Vocabulary
- ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM D1898
- ASTM D2857 Standard Practice for Dilute Solution Viscosity of Polymers
- ASTM D3536 Standard Test Method for Molecular Weight Averages And Molecular Weight Distribution Of Polystyrene By Liquid Exclusion Chromatography (Gel Permeation Chromatography - Gpc)
- ASTM D3593 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Certain Polymers by Liquid Size-Exclusion Chromatography (Gel Permeation Chromatography GPC) Using Universal Calibration
- ASTM D4603 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
- ASTM E1252 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
- ASTM E386 Standard Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F2579-06e1 history
- 2018 ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- 2010 ASTM F2579-10 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- 2008 ASTM F2579-08 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- 2006 ASTM F2579-06e1 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- 2006 ASTM F2579-06 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
