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This specification covers the material characteristics of virgin poly(glycolide) and poly(glycolide-co-lactide) resins with mole fractions within the specified range used in surgical implants. This does not cover packaged and sterilized finished implants fabricated from the same materials. Since some characteristics may be altered by processing techniques when used to produces a specific part or device, properties of fabricated forms of the resins should be evaluated independently using appropriate test methods. The identity of the poly(glycolide) homopolymer, poly(glycolide-co-lactide) copolymer, and poly(glycolide-co-lactide) polymer must be confirmed through nuclear magnetic resonance (NMR).
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers both virgin poly(glycolide) homopolymer and poly(glycolide-co-lactide) copolymer resins intended for use in surgical implants. The poly(glycolide-colactide) copolymers covered by this specification possess nominal mole fractions greater than or equal to 70 % glycolide (65.3 % in mass fraction). This specification is also 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.
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 dl-lactide-based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization.
1.3 This specification is specifically not applicable to amorphous poly(lactide-co-glycolide) or poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane), which are covered in Specification and typically possess molar glycolide levels of ~50 % or less. 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 and typically possess nominal mole fractions that equal or exceed 50 % l-lactide.
1.4 This specification addresses material characteristics of both virgin poly(glycolide) and poly(>70 % glycolide-co-lactide) 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 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO 10993 Biological Evaluation of Medical Devices ISO 11357 PlasticsDifferential Scanning Calorimetry (DSC) ISO 80000-9 Quantities and units -- Part 9: Physical chemistry and molecular physics
ANSI StandardsANSI/ISO/ASQ 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes ANSI/ISO/ASQ Q9000 Quality Management Systems; Fundamentals and Vocabulary ANSI/ISO/ASQ Q9001 Quality Management Systems; Requirements
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D2857 Practice for Dilute Solution Viscosity of Polymers
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
E473 Terminology Relating to Thermal Analysis and Rheology
E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis
E967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers
E968 Practice for Heat Flow Calibration of Differential Scanning Calorimeters
E1142 Terminology Relating to Thermophysical Properties
E1252 Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
E2977 Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
F2902 Guide for Assessment of Absorbable Polymeric Implants
U. S. Pharmacopeia (USP) StandardsUSP 232 United States Pharmacopeia: Elemental Impurities Limits USP 233 United States Pharmacopeia: Elemental Impurities Procedure USP 788 United States Pharmacopeia: Particulate Matter in Injections
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.10 (Thermosetting materials)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F2313-18, 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 International, West Conshohocken, PA, 2018, www.astm.orgBack to Top