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ASTM F 2313 : 2008

NA
NA

Status of Standard is Unknown

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

08-01-2008

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 PLA:PGA 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 these materials.

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

1.6 This standard may suggest use of hazardous materials, operations, and equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 04
DocumentType
Standard
Pages
9
PublisherName
American Society for Testing and Materials
Status
NA
SupersededBy
Supersedes

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
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 2502 : 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

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