ASTM F2313-10
(Specification)Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
ABSTRACT
This specification covers the material characteristics of virgin poly(glycolide) and poly(glycolide-co-lactide) resins with mole fractions within the specified range used in surgical implants. This does not cover packaged and sterilized finished implants fabricated from the same materials. Since some characteristics may be altered by processing techniques when used to produces a specific part or device, properties of fabricated forms of the resins should be evaluated independently using appropriate test methods. The identity of the poly(glycolide) homopolymer, poly(glycolide-co-lactide) copolymer, and poly(glycolide-co-lactide) polymer must be confirmed through nuclear magnetic resonance (NMR).
SCOPE
1.1 This specification covers both virgin poly(glycolide) homopolymer and poly(glycolide-co-lactide) copolymer resins intended for use in surgical implants. The poly(glycolide-co-lactide) copolymers covered by this specification possess nominal mole fractions greater than or equal to 70 % glycolide (65.3 % in mass fraction). This specification is also 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.
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 stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl-lactide-based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization.
1.3 This specification is specifically not applicable to amorphous poly(lactide-co-glycolide) or poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane), which are covered in Specification F2579 and typically possess molar glycolide levels of ~50 % or less. This specification is not applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50 % l-lactide.
1.4 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 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.
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.
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Designation:F2313 −10
Standard Specification for
Poly(glycolide) and Poly(glycolide-co-lactide) Resins for
Surgical Implants with Mole Fractions Greater Than or
1
Equal to 70% Glycolide
This standard is issued under the fixed designation F2313; 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 lactide) resins intended for use in surgical implants and does
not apply to packaged and sterilized finished implants fabri-
1.1 This specification covers both virgin poly(glycolide)
cated from these materials.
homopolymer and poly(glycolide-co-lactide) copolymer resins
intended for use in surgical implants. The poly(glycolide-co- 1.5 As with any material, some characteristics may be
lactide) copolymers covered by this specification possess altered by processing techniques (such as molding, extrusion,
nominal mole fractions greater than or equal to 70 % glycolide machining, assembly, sterilization, etc.) required for the pro-
(65.3 % in mass fraction). This specification is also applicable duction of a specific part or device. Therefore, properties of
to lactide-co-glycolide copolymers that possess glycolide seg- fabricated forms of this resin should be evaluated indepen-
ments sufficient in size to deliver potential for glycolide based dently using appropriate test methods to assure safety and
crystallization, thereby requiring fluorinated solvents for com- efficacy.
plete dissolution under room temperature conditions.
1.6 The values stated in SI units are to be regarded as
1.2 Since poly(glycolide) is commonly abbreviated as PGA standard. No other units of measurement are included in this
for poly(glycolic acid) and poly(lactide) is commonly abbre- standard.
viated as PLA for poly(lactic acid), these polymers are com-
1.7 This standard does not purport to address all of the
monly referred to as PGA, PLA, and PLA:PGA resins for the
safety concerns, if any, associated with its use. It is the
hydrolyticbyproductstowhichtheyrespectivelydegrade.PLA
responsibility of the user of this standard to establish appro-
isatermthatcarriesnostereoisomericspecificityandtherefore
priate safety and health practices and determine the applica-
encompasses both the amorphous atactic/syndiotactic DL-
bility of regulatory limitations prior to use.
lactide-based polymers and copolymers as well as the isotactic
2. Referenced Documents
D-PLAand L-PLAmoieties, each of which carries potential for
2
crystallization.
2.1 ASTM Standards:
D1505 Test Method for Density of Plastics by the Density-
1.3 This specification is specifically not applicable to amor-
Gradient Technique
phous poly(lactide-co-glycolide) or poly(lactide)-based resins
D2857 Practice for Dilute Solution Viscosity of Polymers
able to be fully solvated at 30°C by either methylene chloride
D3418 Test Method for Transition Temperatures and En-
(dichloromethane) or chloroform (trichloromethane), which
thalpies of Fusion and Crystallization of Polymers by
are covered in Specification F2579 and typically possess molar
Differential Scanning Calorimetry
glycolide levels of ~50 % or less. This specification is not
D5296 Test Method for Molecular Weight Averages and
applicable to lactide-based polymers or copolymers that pos-
Molecular Weight Distribution of Polystyrene by High
sess isotactic polymeric segments sufficient in size to carry
Performance Size-Exclusion Chromatography
potential for lactide-based crystallization, which are covered
D4603 Test Method for Determining Inherent Viscosity of
by Specification F1925 and typically possess nominal mole
Poly(Ethylene Terephthalate) (PET) by Glass Capillary
fractions that equal or exceed 50 % L-lactide.
Viscometer
1.4 This specification addresses material characteristics of
E386 Practice for Data Presentation Relating to High-
both virgin poly(glycolide) and poly(>70 % glycolide-co-
Resolution Nuclear Magnetic Resonance (NMR) Spec-
troscopy
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
2
Subcommittee F04.11 on Polymeric Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2010. Published January 2011. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 2003. Last previous edition approved in 2008 as F2313 – 08 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2313-10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-295
...
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:F2313–08 Designation: F2313 – 10
Standard Specification for
Poly(glycolide) and Poly(glycolide-co-lactide) Resins for
Surgical Implants with Mole Fractions Greater Than or
1
Equal to 70 % Glycolide
This standard is issued under the fixed designation F2313; 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 9.1 was editorially corrected in January 2009.
1. Scope
1.1This 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.
1.2Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated
as PLAfor poly(lactic acid), these polymers are commonly referred to as PGAand PLA:PGAresins for the hydrolytic byproducts
to which they respectively degrade.
1.3This 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 these
materials.
1.4As 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.
1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6This standard may suggest use of hazardous materials, operations, and equipment. 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.
1.1 This specification covers both virgin poly(glycolide) homopolymer and poly(glycolide-co-lactide) copolymer resins
intended for use in surgical implants. The poly(glycolide-co-lactide) copolymers covered by this specification possess nominal
mole fractions greater than or equal to 70 % glycolide (65.3 % in mass fraction). This specification is also 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.
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. PLAis a term that carries no stereoisomeric specificity and therefore encompasses
both the amorphous atactic/syndiotactic DL-lactide-based polymers and copolymers as well as the isotactic D-PLA and L-PLA
moieties, each of which carries potential for crystallization.
1.3 This specification is specifically not applicable to amorphous poly(lactide-co-glycolide) or poly(lactide)-based resins able
to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane), which are covered
in Specification F2579 and typically possess molar glycolide levels of ~50 % or less. This specification is not applicable to
lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for
lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or
exceed 50 % L-lactide.
1.4 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 these
materials.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subc
...
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