ASTM-F2313 › Historical Revision Information
Poly(Glycolide) & Poly(GLYCOLIDE-Co-Lactide) Resins for Surical Implants With Mole Fra
The following bibliographic material is provided to assist you with your purchasing decision:
Scope
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.
Keywords
poly(glycolic acid); poly(glycolide); PGA; poly(glycolide:lactide); poly(glycolide-co-lactide); PLA; PGA:PLA; polyglycolic:lactic acid; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.10 (Thermosetting materials)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
83.080.10 (Thermosetting materials Including ebonite Silicones, see 71.100.55)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ASTM-F2313-03
Revision Level
2003 EDITION
Status
Superseded
Modification Type
New
Publication Date
Nov. 1, 2003
Document Type
Specification
Page Count
7 pages
Committee Number
F04.11