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  • ASTM F 1925 : 2017

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

    Available format(s):  Hardcopy, PDF

    Superseded date:  09-03-2022

    Language(s):  English

    Published date:  13-02-2018

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This specification covers virgin semi-crystalline poly(l-lactide) or poly(d-lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l-lactide copolymerized with other bioabsorbable monomers including, but not limited to, glycolide, d-lactide, and dl-lactide. The poly(l -lactide) or poly(d-lactide) based homopolymers and copolymers covered by this specification possess lactide segments of sufficient length to allow potential for their crystallization upon annealing.

    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. 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 is applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization. Such polymers typically possess nominal mole fractions that equal or exceed 50 % l-lactide. This specification is particularly applicable to isotactic-lactide based 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). This specification is 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 amorphous polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by less than 1.5 total mole percent (1.5 % of total moles) as covered by Specification F2579.

    1.4This specification covers virgin semi-crystalline 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: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 (see Specification F2313).

    1.5Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm after annealing above the glass transition temperature. While other copolymeric segments may also crystallize upon annealing (for example, glycolide), specific characterization of crystalline structures other than those formed by lactide are outside the scope of this specification.

    1.6This specification addresses material characteristics of the virgin semi-crystalline poly(lactide) based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials.

    1.7As 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.

    1.8Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices.

    1.9The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.10This 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.

    1.11This 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
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    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 2579 : 2018 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM F 2502 : 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    ASTM F 3384 : 2021 Standard Specification for Polydioxanone Polymer 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 E 1142 : 2022 Standard Terminology Relating to Thermophysical Properties
    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 D 3418 : 2012 : EDT 1 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    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 D 3418 : 1982 : R1988 : EDT 1 Standard Test Method for Transition Temperatures of Polymers By Thermal Analysis
    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 E 1142 : 2011 : REV A Standard Terminology Relating to Thermophysical Properties
    ASTM D 3418 : 1999 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
    ASTM D 2857 : 1995 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM E 1142 : 2012 Standard Terminology Relating to Thermophysical Properties
    ASTM D 3418 : 2021 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM E 473 : 2022 Standard Terminology Relating to Thermal Analysis and Rheology
    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 1142 : 1997 Standard Terminology Relating to Thermophysical Properties
    ASTM E 473 : 2021 Standard Terminology Relating to Thermal Analysis and Rheology
    ASTM E 2977 : 2014 Standard Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples
    ASTM E 1142 : 2013 Standard Terminology Relating to Thermophysical Properties
    ASTM D 5296 : 1997 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM E 1142 : 2004 Standard Terminology Relating to Thermophysical Properties
    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 1142 : 2006 : REV A Standard Terminology Relating to Thermophysical Properties
    ASTM E 473 : 2018 Standard Terminology Relating to Thermal Analysis and Rheology
    ASTM E 1142 : 2015 : R2020 Standard Terminology Relating to Thermophysical Properties
    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 2579 : 2008 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM E 1356 : 2008 Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
    ASTM E 1142 : 2021 : REV A Standard Terminology Relating to Thermophysical Properties
    ASTM D 3418 : 2012 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3418 : 2003 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM E 1252 : 1998 : R2021 Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
    ASTM D 3418 : 2015 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    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 E 1142 : 2007 Standard Terminology Relating to Thermophysical Properties
    ASTM E 1994 : 1998 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM E 1356 : 2003 Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
    ASTM D 1505 : 1968 : R1979 Standard Test Method for Density Of Plastics By The Density-Gradient Technique
    ASTM E 1356 : 2008 : R2014 Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
    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 E 1142 : 2014 : REV A Standard Terminology Relating to Thermophysical Properties
    ASTM D 3418 : 2008 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM E 1142 : 2014 : REV B Standard Terminology Relating to Thermophysical Properties
    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 E 1142 : 2005 Standard Terminology Relating to Thermophysical Properties
    ASTM F 2579 : 2010 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM D 1505 : 2018 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM E 1142 : 2015 Standard Terminology Relating to Thermophysical Properties
    ASTM E 473 : 2021 : REV A Standard Terminology Relating to Thermal Analysis and Rheology
    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 F 2579 : 2006 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM D 1505 : 1998 : EDT 1 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM E 968 : 1999 Standard Practice for Heat Flow Calibration of Differential Scanning Calorimeters
    ASTM F 2579 : 2018 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) 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 E 1356 : 1998 Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry or Differential Thermal Analysis
    ASTM E 1142 : 2011 : REV B Standard Terminology Relating to Thermophysical Properties
    ASTM E 1142 : 2021 Standard Terminology Relating to Thermophysical Properties
    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 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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