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ASTM F2313-03

Historical Revision

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

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1.1 This specification covers both virgin poly(glycolide) resin and poly(glycolide-co-lactide) resin with mole fractions greater than or equal to 70 % glycolide. This specification is not applicable to glycolide:lactide copolymers with mole fractions exceeding 30 % 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 and PGA:PLA resins for the hydrolytic byproducts to which they respectively degrade.

1.3 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 this material.

1.4 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 ensure safety and efficacy.

1.5 This standard may suggest use of hazardous materials, operations, and equipment. This standard does not purport to address safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.


SDO ASTM: ASTM International
Document Number F2313
Publication Date Nov. 1, 2003
Language en - English
Page Count 7
Revision Level 03
Supercedes
Committee F04.11
Publish Date Document Id Type View
Dec. 1, 2024 F2313-24 Revision
Dec. 15, 2018 F2313-18 Revision
Dec. 1, 2010 F2313-10 Revision
Aug. 1, 2008 F2313-08E01 Revision
Aug. 1, 2008 F2313-08 Revision
Nov. 1, 2003 F2313-03 Revision