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ASTM F 2313 : 2024

Current

Current

The latest, up-to-date edition.

Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-12-2024

€56.53
Excluding VAT

Committee
F 04
DocumentType
Standard
Pages
10
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This 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, which may occur in certain segmented or block copolymers or blocky random copolymers.

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.

1.3This 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 F2579 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 F1925 and typically possess nominal mole fractions that equal or exceed 50 % l-lactide.

1.4This 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, nor does it address the characteristics of resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives.

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 ensure safety and efficacy.

1.6Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. While biocompatibility testing of resin may provide an early indication of potential safety, biocompatibility analysis of the final finished device is required to determine safety and suitability for any implant device. Refer to Supplementary Requirement S1 of this standard and Guide F2902 for relevant biocompatibility information.

1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8This 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.

1.9This 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.

ASTM F 2902 : 2024 Standard Guide for Assessment of Absorbable Polymeric Implants
ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2502 : 2024 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
ASTM F 1925 : 2024 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

ASTM F 2579 : 2024 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

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