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  • ASTM F 2579 : 2018

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-12-2018

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins intended for use in surgical implants.

    Scope - (Show below) - (Hide below)

    1.1This 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-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.

    1.2Since 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 dl-lactide-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(dl-lactide) as PdlLA for poly(dl-lactic acid).

    1.3This 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).

    1.4This 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.

    1.5As 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.

    1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.7This 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.

    1.8This 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.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO ANSI/ISO/ASQ 13485, ANSI/ISO/ASQ Q9000, ANSI/ISO/ASQ Q9001, ISO 10993, USP 231, USP 232, USP 233,USP 781, USP 788, ICH Q3C, ICH Q3D, 21 CFR 820, NIST Special Publication SP811.
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 2313 : 2018 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 F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 2502 : 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM F 1925 : 2017 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 4603 : 2003 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
    ASTM E 1994 : 2009R Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM E 1994 : 2008 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM D 2857 : 1995 : R2001 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM E 1252 : 1998 : R2007 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM E 1252 : 1998 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM D 2857 : 1995 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 5296 : 2005 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM E 2977 : 2014 Standard Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples
    ASTM D 5296 : 1997 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM F 2313 : 2018 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 E 2977 : 2015 Standard Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples
    ASTM D 1505 : 2003 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM F 2902 : 2016 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM E 1252 : 1998 : R2021 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM F 1925 : 2017 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM F 1925 : 1999 : EDT 1 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
    ASTM D 4603 : 2018 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
    ASTM D 5296 : 2011 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM D 2857 : 1995 : R2007 Standard Practice for Dilute Solution Viscosity of Polymers (Withdrawn 2016)
    ASTM D 2857 : 1970 : R1977 Standard Test Method for Dilute Solution Viscosity Of Polymers
    ASTM D 4603 : 1996 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
    ASTM F 2313 : 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
    ASTM F 2313 : 2008 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 D 2857 : 2022 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM E 1994 : 1998 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM D 1505 : 1968 : R1979 Standard Test Method for Density Of Plastics By The Density-Gradient Technique
    ASTM F 1925 : 2022 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM E 1994 : 2009 : R2013 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM E 1994 : 2009 : R2018 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM D 1505 : 2010 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 5296 : 2019 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM D 1505 : 2018 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM F 2313 : 2008 : EDT 1 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 D 1505 : 1998 : EDT 1 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM F 1925 : 2009 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM F 2313 : 2003 Standard Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide
    ASTM F 2902 : 2012 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM E 1252 : 1998 : R2013 : EDT 1 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM E 1252 : 1998 : R2002 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM F 1925 : 1999 : R2005 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
    ASTM D 4603 : 2003 : R2011 : EDT 1 Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
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