ASTM F2313-08e1

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:F2313–03 Designation: F 2313 – 08
Standard Specification for
Virgin 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 F 2313; 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
1.1 This 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.
1.2 Since poly(glycolide) is commonly abbreviated as PGAfor poly(glycolic acid) and poly(lactide) is commonly abbreviated
as PLAfor poly(lactic acid), these polymers are commonly referred to as PGAand PGA:PLAPLA:PGAresins for the hydrolytic
byproducts to which they respectively degrade.
1.3 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 thiese
materials.
1.4 Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,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.
1.5This standard may suggest use of hazardous materials, operations, and equipment. This standard does not purport to address
safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health
practices and to determine the applicability of regulatory limitations prior to use.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1898Practice for Sampling of Plastics
D 2857 Practice for Dilute Solution Viscosity of Polymers
3
D 3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
D 3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential
Scanning Calorimetry
D 3536 Test Method for MolecularWeightAverages and MolecularWeight Distribution by Liquid Exclusion Chromatography
0
(Gel Permeation Chromatography—GPC)
D 3593 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Certain Polymers by Liquid
0
Size-Exclusion Chromatography (Gel Permeation Chromatography—GPC) Using Universal Calibration
1
This specification is under the jurisdiction ofASTM Committee F04 on Medical Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11
on Polymeric Materials.
Current edition approved Nov. 1, 2003. Published November 2003.
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 Aug. 1, 2008. Published September 2008. Originally approved in 2003. Last previous edition approved in 2003 as F 2313 – 03.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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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: F 2313 – 08
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 F 2313; 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
1.1 This 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.
1.2 Since poly(glycolide) is commonly abbreviated as PGAfor 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.
1.3 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.
1.4 Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1505 Test Method for Density of Plastics by the Density-Gradient Technique
D 2857 Practice for Dilute Solution Viscosity of Polymers
3
D 3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
D 3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential
Scanning Calorimetry
D 3536 Test Method for MolecularWeightAverages and MolecularWeight Distribution by Liquid Exclusion Chromatography
0
(Gel Permeation Chromatography—GPC)
D 3593 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Certain Polymers by Liquid
0
Size-Exclusion Chromatography (Gel Permeation Chromatography—GPC) Using Universal Calibration
D 4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
E 386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy
E 473 Terminology Relating to Thermal Analysis and Rheology
E 793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E 794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis
E 967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers
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 Aug. 1, 2008. Published September 2008. Originally approved in 2003. Last previous edition approved in 2003 as F 2313 – 03.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2313–08
E 968 Practice for Heat Flow Calibration of Differen
...