ASTM F2579-06e1

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation: F 2579 – 06
Standard Specification for
Amorphous Poly(lactide) and Poly(lactide-co-glycolide)
1
Resins for Surgical Implants
This standard is issued under the fixed designation F 2579; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Section 5.9 was added and figures were corrected editorially in January 2007.
1. Scope applicable to block copolymers or to polymers or copolymers
synthesized from combinations of d-lactide and l-lactide that
1.1 This specification covers virgin poly(lactide) and
differ by more than 1.5 total mole percent (1.5 % of total
poly(lactide-co-glycolide) resins able to be fully solvated at
moles).
30°C by either methylene chloride (dichloromethane) or chlo-
1.4 This specification addresses material characteristics of
roform (trichloromethane). The poly(d,l-lactide) homopoly-
both poly(lactide) and poly(lactide-co-glycolide) resins in-
mers covered by this specification are considered to be
tended for use in surgical implants and does not apply to
amorphous (that is, void of crystallinity) and are polymerized
packaged and sterilized finished implants fabricated from these
either from meso-lactide or from equimolar (racemic) combi-
materials.
nations of d-lactide and l-lactide. The poly(d,l-lactide-co-
1.5 As with any material, some characteristics may be
glycolide) copolymers covered by this specification are also
altered by processing techniques (such as molding, extrusion,
considered to be amorphous and are co-polymerized from a
machining, assembly, sterilization, etc.) required for the pro-
combination of glycolide and either meso-lactide or racemic
duction of a specific part or device. Therefore, properties of
quantities of d-lactide and l-lactide, and typically possess
fabricated forms of this resin should be evaluated indepen-
nominal mole fractions that equal or exceed 50 % lactide.
dently using appropriate test methods to assure safety and
1.2 Since poly(glycolide) is commonly abbreviated as PGA
efficacy.
for poly(glycolic acid) and poly(lactide) is commonly abbre-
1.6 This standard does not purport to address all of the
viated as PLA for poly(lactic acid), these polymers are com-
safety concerns, if any, associated with its use. It is the
monly referred to as PGA, PLA, and PLA:PGA resins for the
responsibility of the user of this standard to establish appro-
hydrolyticbyproductstowhichtheyrespectivelydegrade.PLA
priate safety and health practices and determine the applica-
is a term that carries no enantiomeric specificity and therefore
bility of regulatory limitations prior to use.
alsoencompassestheisotactic d-PLAand l-PLAmoieties,each
of which carries potential for crystallization. Therefore, spe-
2. Referenced Documents
cific reference to d,l-PLA is essential to appropriately differ-
2
2.1 ASTM Standards:
entiate the amorphous atactic/syndiotactic d,l-lactide based
D 1505 Test Method for Density of Plastics by the Density-
polymers and copolymers covered by this specification.
Gradient Technique
1.3 This specification is not applicable to lactide based
3
D 1898 Practice for Sampling of Plastics
polymers or copolymers that possess isotactic polymeric seg-
D 2857 Practice for Dilute Solution Viscosity of Polymers
ments sufficient in size to deliver potential for lactide based
D 3536 Test Method for Molecular Weight Averages and
crystallization. This specification is not applicable to lactide-
Molecular Weight Distribution of Polystyrene by Liquir
co-glycolide copolymers that possess glycolide segments suf-
Exclusion Chromatography (Gel Permeation
ficient in size to deliver potential for glycolide based crystal-
3
Chromatography-GPC)
lization, thereby requiring fluorinated solvents for complete
D 3593 Test Method for Molecular Weight Averages and
dissolution under room temperature conditions. This specifica-
Molecular Weight Distribution of Certain Polymers by
tion is specifically not applicable to lactide-co-glycolide co-
Liquid Size-Exclusion Chromatography (Gel Permeation
polymers with glycolide mole fractions greater than or equal to
3
Chromatography GPC) Using Universal Calibration
70 % (65.3 % in mass fraction). This specification is not
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This specification is under the jurisdiction of ASTM Committee F04 on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Medical and Surgical Materials and Devices and is the direct responsibility of
Standards volume information, refer to the standard’s Document Summary page on
Subcommittee F04.11 on Polymeric Materials.
the
...