ASTM-F2579 2006

$40.63

F2579-06 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

Published By	Publication Date	Number of Pages
ASTM	2006	10

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F2579-06

Historical Standard: Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

ASTM F2579

Scope

1.1 This specification covers virgin poly(lactide) and poly(lactide-co-glycolide) resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers covered by this specification are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50 % 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, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no enantiomeric specificity and therefore also encompasses the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to d,l-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic d,l-lactide based polymers and copolymers covered by this specification.

1.3 This specification is not applicable to lactide based polymers or copolymers that possess isotactic polymeric segments sufficient in size to deliver potential for lactide based crystallization. This specification is not 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. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction). This specification is not applicable to block copolymers or to polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5 % of total moles).

1.4 This specification addresses material characteristics of both poly(lactide) and poly(lactide-co-glycolide) 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, etc.) 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.

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.

Keywords

PGA:PLA; PLA; PLA:PGA; PLGA; polyglycolic:lactic acid; poly(glycolide-co-lactide); poly(glycolide:lactide); poly(lactic acid); polylactic:glycolic acid; poly(lactide); poly(lactide-co-glycolide); poly(lactide:glycolide)

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2579-06

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Materials and Manufacture Chemical Composition
3	FIG. 1
4	FIG. 2
5	FIG. 2 FIG. 3
6	FIG. 4 TABLE 1
7	Physical Properties Performance Requirements
8	Dimensions, Mass, and Permissible Variations Sampling Certification Packaging and Package Marking Guidance for Manufacturing Control and Quality Assurance Keywords
9	X1. NOMENCLATURE X1.1 X1.2 X2. RATIONALE X2.1 X2.2 X2.3 X2.4
10	X2.5 TABLE X2.1

Additional information

Standard Title	F2579-06 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
Published Code	ASTM
Publication Date	2006
Pages Count	10
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics