ASTM F2579-10

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation:F2579 −10
Standard Specification for
Amorphous Poly(lactide) and Poly(lactide-co-glycolide)
1
Resins for Surgical Implants
This standard is issued under the fixed designation F2579; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope polymeric segments sufficient in size to carry potential for
lactide-based crystallization, which are covered by Specifica-
1.1 Thisspecificationcoversvirginamorphouspoly(lactide)
tion F1925 and typically possess nominal mole fractions that
homopolymer and poly(lactide-co-glycolide) copolymer resins
equal or exceed 50 % L-lactide. This specification is not
intended for use in surgical implants. The poly(DL-lactide)
applicable to lactide-co-glycolide copolymers that possess
homopolymers covered by this specification are considered to
glycolide segments sufficient in size to deliver potential for
be amorphous (that is, void of crystallinity) and are polymer-
glycolide-based crystallization, thereby requiring fluorinated
ized either from meso-lactide or from equimolar (racemic)
solvents for complete dissolution under room temperature
combinations of D-lactide and L-lactide. The poly(DL-lactide-
conditions. This specification is specifically not applicable to
co-glycolide) copolymers covered by this specification are also
lactide-co-glycolide copolymers with glycolide mole fractions
considered to be amorphous and are co-polymerized from a
greater than or equal to 70 % (65.3 % in mass fraction), which
combination of glycolide and either meso-lactide or racemic
are covered by Specification F2313. This specification is not
quantities of D-lactide and L-lactide, and typically possess
applicable to block copolymers or to polymers or copolymers
nominal mole fractions that equal or exceed 50 % lactide.
synthesized from combinations of D-lactide and L-lactide that
1.2 Since poly(glycolide) is commonly abbreviated as PGA
differ by more than 1.5 total mole percent (1.5 % of total
for poly(glycolic acid) and poly(lactide) is commonly abbre-
moles).
viated as PLA for poly(lactic acid), these polymers are com-
1.4 This specification addresses material characteristics of
monly referred to as PGA, PLA, and PLA:PGA resins for the
both poly(DL-lactide) and poly(DL-lactide-co-glycolide) resins
hydrolyticbyproductstowhichtheyrespectivelydegrade.PLA
intended for use in surgical implants and does not apply to
isatermthatcarriesnostereoisomericspecificityandtherefore
packaged and sterilized finished implants fabricated from these
encompasses both the amorphous atactic/syndiotactic DL-
materials.
lactide-based polymers and copolymers as well as the isotactic
D-PLAand L-PLAmoieties, each of which carries potential for 1.5 As with any material, some characteristics may be
crystallization. Therefore, specific reference to DL-PLA is altered by processing techniques (such as molding, extrusion,
essential to appropriately differentiate the amorphous atactic/ machining, assembly, sterilization, and so forth) required for
syndiotactic DL-lactide-based polymers and copolymers cov- the production of a specific part or device. Therefore, proper-
ered by this specification. Thus, inclusion of stereoisomeric ties of fabricated forms of this resin should be evaluated
specificity within the lactic acid-based acronyms results in the independently using appropriate test methods to assure safety
following: poly(L-lactide) as PLLA for poly(L-lactic acid), and efficacy.
poly(D-lactide) as PDLA for poly(D-lactic acid), and poly(DL-
1.6 The values stated in SI units are to be regarded as
lactide) as PDLLA for poly(DL-lactic acid).
standard. No other units of measurement are included in this
1.3 This specification covers virgin amorphous standard.
poly(lactide)-based resins able to be fully solvated at 30°C by
1.7 This standard does not purport to address all of the
either methylene chloride (dichloromethane) or chloroform
safety concerns, if any, associated with its use. It is the
(trichloromethane). This specification is not applicable to
responsibility of the user of this standard to establish appro-
lactide-based polymers or copolymers that possess isotactic
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2010. Published January 2011. Originally
approved in 2006. Last previous edition approved in 2008 as F2579 – 08. DOI:
10.1520/F2579
...