ASTM F2579-08

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:F2579–06 Designation: F 2579 – 08
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 (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Section 5.9 was added and figures were corrected editorially in January 2007.
1. Scope
1.1 Thisspecificationcoversvirginpoly(lactide)andpoly(lactide-co-glycolide)resinsabletobefullysolvatedat30°Cbyeither
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
specificationarealsoconsideredtobeamorphousandareco-polymerizedfromacombinationofglycolideandeither 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 PGAfor 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 Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,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.
1.6
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1505 Test Method for Density of Plastics by the Density-Gradient Technique D1898 Practice for Sampling of Plastics
D 2857 Practice for Dilute Solution Viscosity of Polymers
D 3536 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by Liquir Exclusion
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 Oct. 1, 2006. Published November 2006.
´1
Current edition approved Dec. 1, 2008. Published January 2009. Originall
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:F2579–06 Designation: F 2579 – 08
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 (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Section 5.9 was added and figures were corrected editorially in January 2007.
1. Scope
1.1 Thisspecificationcoversvirginpoly(lactide)andpoly(lactide-co-glycolide)resinsabletobefullysolvatedat30°Cbyeither
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
specificationarealsoconsideredtobeamorphousandareco-polymerizedfromacombinationofglycolideandeither 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 PGAfor 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 Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,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.
1.6
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1505 Test Method for Density of Plastics by the Density-Gradient Technique D1898 Practice for Sampling of Plastics
D 2857 Practice for Dilute Solution Viscosity of Polymers
D 3536 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by Liquir Exclusion
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 Oct. 1, 2006. Published November 2006.
´1
Current edition approved Dec. 1, 2008. Published January 2009. Originall
...