ASTM F2313-18
(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-colactide) 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, 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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F2313 −18
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- 1.5 As with any material, some characteristics may be
colactide) 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, and so forth) required for
(65.3 % in mass fraction). This specification is also applicable the production of a specific part or device. Therefore, proper-
to lactide-co-glycolide copolymers that possess glycolide seg- ties of fabricated forms of this resin should be evaluated
ments sufficient in size to deliver potential for glycolide-based independently using appropriate test methods to assure safety
crystallization, thereby requiring fluorinated solvents for com- and 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, health, and environmental practices and deter-
encompasses both the amorphous atactic/syndiotactic DL-
mine the applicability of regulatory limitations prior to use.
lactide-based polymers and copolymers as well as the isotactic
1.8 This international standard was developed in accor-
D-PLAand L-PLAmoieties, each of which carries potential for
dance with internationally recognized principles on standard-
crystallization.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.3 This specification is specifically not applicable to amor-
mendations issued by the World Trade Organization Technical
phous poly(lactide-co-glycolide) or poly(lactide)-based resins
Barriers to Trade (TBT) Committee.
able to be fully solvated at 30°C by either methylene chloride
(dichloromethane) or chloroform (trichloromethane), which
2. Referenced Documents
are covered in Specification F2579 and typically possess molar
2
glycolide levels of ~50 % or less. This specification is not
2.1 ASTM Standards:
applicable to lactide-based polymers or copolymers that pos-
D1505 Test Method for Density of Plastics by the Density-
sess isotactic polymeric segments sufficient in size to carry
Gradient Technique
potential for lactide-based crystallization, which are covered
D2857 Practice for Dilute Solution Viscosity of Polymers
by Specification F1925 and typically possess nominal mole
D3418 Test Method for Transition Temperatures and En-
fractions that equal or exceed 50 % L-lactide.
thalpies of Fusion and Crystallization of Polymers by
Differential Scanning Calorimetry
1.4 This specification addresses material characteristics of
D5296 Test Method for Molecular Weight Averages and
both virgin poly(glycolide) and poly(>70 % glycolide-co-
Molecular Weight Distribution of Polystyrene by High
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. 15, 2018. Published February 2019. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2010 as F2
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F2313 − 10 F2313 − 18
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
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)poly(glycolide-colactide) copolymers covered by this
specification possess nominal mole fractions greater than or equal to 70 % glycolide (65.3 % 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 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.) 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 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2010Dec. 15, 2018. Published January 2011February 2019. Originally approved in 2003. Last previous edition approved in 20082010
ε1
as F2313 – 08F2313 – 10. . DOI: 10.1520/F2313-10.10.1520/F2313-18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2313 − 18
2. Referenced Documents
2
2.1 ASTM Standards:
D1505 Test Method for Density of Plastics
...
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