ASTM F2579-18
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

Standard No.

ASTM F2579-18

Release Date

2018

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2579-18

Scope

1.1 This specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins intended for use in surgical implants. The poly(DL-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(DL-lactideco-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 stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic DLlactide-based polymers and copolymers as well as the isotactic D-PLA and L-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to DL-PLA is essential to appropriately differentiate the amorphous atactic/ syndiotactic DL-lactide-based polymers and copolymers covered by this specification. Thus, inclusion of stereoisomeric specificity within the 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(DLlactide) as PDLLA for poly(DL-lactic acid). 1.3 This specification covers virgin amorphous poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50 % L-lactide. 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), which are covered by Specification F2313. 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(DL-lactide) and poly(DL-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, and so forth) 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. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the 1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11 on Polymeric Materials. Current edition approved Dec. 15, 2018. Published February 2019. Originally approved in 2006. Last previous edition approved in 2010 as F2579 – 10. DOI: 10.1520/F2579-18. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F2579-18 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 D2857 Standard Practice for Dilute Solution Viscosity of Polymers
• ASTM D4603 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
• ASTM D5296 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
• ASTM E1252 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis*， 2021-04-01 Update
• ASTM E1994 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
• ASTM E2977 Standard Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples*， 2023-01-01 Update
• ASTM F1925 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
• ASTM F2313 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
• ASTM F2902 Standard Guide for Assessment of Absorbable Polymeric Implants
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 80000-9 Quantities and units — Part 9: Physical chemistry and molecular physics — Amendment 1

ASTM F2579-18 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