ASTM F2214-16
(Test Method)Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
Standard Test Method for <emph type="bdit">In Situ</emph> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
SIGNIFICANCE AND USE
5.1 This test method is designed to produce data indicative of the degree of crosslinking in ultra high molecular weight polyethylene that has been crosslinked chemically or by ionizing radiation.
5.2 The results are sensitive to the test temperature, solvent, and method used. For the comparison of data between institutions, care must be taken to have the same test conditions and reagents.
5.3 The data can be used for dose uniformity analysis, fundamental research, and quality assurance testing.
SCOPE
1.1 This test method describes how the crosslink density, molecular weight between crosslinks, and number of repeat units between crosslinks in ultra-high molecular weight polyethylene (UHMWPE) crosslinked by ionizing radiation or by chemical means can be determined by measuring the swelling ratio of samples immersed in o-xylene. Examples of experimental techniques used to make these measurements are discussed herein.
1.2 The test method reported here measures the change in height of a sample specimen while it is immersed in the solvent. Volumetric swell ratios assume that the sample is crosslinked isotropically, and that the change in dimension will be uniform in all directions. This technique avoids uncertainty induced by solvent evaporation or temperature change.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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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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: F2214 − 16
Standard Test Method for
In Situ Determination of Network Parameters of Crosslinked
1
Ultra High Molecular Weight Polyethylene (UHMWPE)
This standard is issued under the fixed designation F2214; 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 3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1.1 This test method describes how the crosslink density,
3.1.1 crosslink density, ν —the theoretical average number
molecular weight between crosslinks, and number of repeat
d
3
units between crosslinks in ultra-high molecular weight poly- of crosslinks per unit volume [mol/dm ].
ethylene (UHMWPE) crosslinked by ionizing radiation or by
3.1.2 molecular weight between crosslinks, M —the theo-
c
chemical means can be determined by measuring the swelling
retical average molecular weight between crosslinks [g/mol].
ratio of samples immersed in o-xylene. Examples of experi-
3.1.3 swell ratio, q —the ratio of the volume of the sample
mental techniques used to make these measurements are s
in an equilibrium swollen state to its volume in the unswollen
discussed herein.
state.
1.2 The test method reported here measures the change in
height of a sample specimen while it is immersed in the
4. Summary of Test Method
solvent. Volumetric swell ratios assume that the sample is
4.1 The height of a cubic specimen is measured, and the
crosslinked isotropically, and that the change in dimension will
specimen is placed in a dry chamber. A selected solvent is
be uniform in all directions. This technique avoids uncertainty
chosenaccordingtotheFlorynetworktheoryandisintroduced
induced by solvent evaporation or temperature change.
into the chamber. The chamber is heated to the reference
1.3 The values stated in SI units are to be regarded as
temperature. The sample height is monitored as a function of
standard. No other units of measurement are included in this
time until steady state (equilibrium) is achieved. The swell
standard.
ratio is calculated from the final steady state (equilibrium)
height and the initial height.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
5. Significance and Use
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
5.1 This test method is designed to produce data indicative
bility of regulatory limitations prior to use.
of the degree of crosslinking in ultra high molecular weight
polyethylene that has been crosslinked chemically or by
2. Referenced Documents
ionizing radiation.
2
2.1 ASTM Standards:
5.2 The results are sensitive to the test temperature, solvent,
D2765 Test Methods for Determination of Gel Content and
and method used. For the comparison of data between
Swell Ratio of Crosslinked Ethylene Plastics
institutions,caremustbetakentohavethesametestconditions
E691 Practice for Conducting an Interlaboratory Study to
and reagents.
Determine the Precision of a Test Method
5.3 The data can be used for dose uniformity analysis,
fundamental research, and quality assurance testing.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
6. Apparatus
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
6.1 The apparatus shall include any device that allows a
Current edition approved Oct. 1, 2016. Published October 2016. Originally
non-invasive measurement of the change in one dimension of
approved in 2002. Last previous edition approved in 2008 as F2214 – 02 (2008).
DOI: 10.1520/F2214-16. the sample as it swells in the solvent. This measurement could
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
include, but is not limited to:
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6.1.1 Mechanical measurements, such as linear variable
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. displacement transducers (LVDTs).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2214 − 16
FIG. 1 Marked Measurement Direction Before (a) and After (b) Swelling
6.1.1.1 If a mechanical probe is used, it must be constructed 7.2 Anti-oxidant, 2,2'-methylene-bis (4-methyl-6-tertiary
3
...
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: F2214 − 02 (Reapproved 2008) F2214 − 16
Standard Test Method for
In Situ Determination of Network Parameters of Crosslinked
1
Ultra High Molecular Weight Polyethylene (UHMWPE)
This standard is issued under the fixed designation F2214; 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 test method describes how the crosslink density, molecular weight between crosslinks, and number of repeat units
between crosslinks in ultra-high molecular weight polyethylene (UHMWPE) crosslinked by ionizing radiation or by chemical
means can be determined by measuring the swelling ratio of samples immersed in o-xylene. Examples of experimental techniques
used to make these measurements are discussed herein.
1.2 The test method reported here measures the change in height of a sample specimen while it is immersed in the solvent.
Volumetric swell ratios assume that the sample is crosslinked isotropically, and that the change in dimension will be uniform in
all directions. This technique avoids uncertainty induced by solvent evaporation or temperature change.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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:
D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3
3.1.1 crosslink density, ν —the theoretical average number of crosslinks per unit volume [mol/dm ].
d
3.1.2 molecular weight between crosslinks, M —the theoretical average molecular weight between crosslinks [g/mol].
c
3.1.3 swell ratio, q —the ratio of the volume of the sample in an equilibrium swollen state to its volume in the unswollen state.
s
4. Summary of Test Method
4.1 The height of a cubic specimen is measured, and the specimen is placed in a dry chamber. A selected solvent is chosen
according to the Flory network theory and is introduced into the chamber. The chamber is heated to the reference temperature. The
sample height is monitored as a function of time until steady state (equilibrium) is achieved. The swell ratio is calculated from the
final steady state (equilibrium) height and the initial height.
5. Significance and Use
5.1 This test method is designed to produce data indicative of the degree of crosslinking in ultra high molecular weight
polyethylene that has been crosslinked chemically or by ionizing radiation.
5.2 The results are sensitive to the test temperature, solvent, and method used. For the comparison of data between institutions,
care must be taken to have the same test conditions and reagents.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved May 1, 2008Oct. 1, 2016. Published June 2008October 2016. Originally approved in 2002. Last previous edition approved in 20022008 as
F2214 – 02.F2214 – 02 (2008). DOI: 10.1520/F2214-02R08.10.1520/F2214-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2214 − 16
5.3 The data can be used for dose uniformity analysis, fundamental research, and quality assurance testing.
6. Apparatus
6.1 The apparatus shall include any device that allows a non-invasive measurement of the change in one dimension of the
sample as it swells in the solvent. This measurement could include, but is not limited to:
6.1.1 Mechanical measurements, such as linear variable displacem
...
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: F2214 − 16
Standard Test Method for
In Situ Determination of Network Parameters of Crosslinked
1
Ultra High Molecular Weight Polyethylene (UHMWPE)
This standard is issued under the fixed designation F2214; 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 3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1.1 This test method describes how the crosslink density,
molecular weight between crosslinks, and number of repeat 3.1.1 crosslink density, ν —the theoretical average number
d
3
of crosslinks per unit volume [mol/dm ].
units between crosslinks in ultra-high molecular weight poly-
ethylene (UHMWPE) crosslinked by ionizing radiation or by
3.1.2 molecular weight between crosslinks, M —the theo-
c
chemical means can be determined by measuring the swelling
retical average molecular weight between crosslinks [g/mol].
ratio of samples immersed in o-xylene. Examples of experi-
3.1.3 swell ratio, q —the ratio of the volume of the sample
s
mental techniques used to make these measurements are
in an equilibrium swollen state to its volume in the unswollen
discussed herein.
state.
1.2 The test method reported here measures the change in
height of a sample specimen while it is immersed in the
4. Summary of Test Method
solvent. Volumetric swell ratios assume that the sample is
4.1 The height of a cubic specimen is measured, and the
crosslinked isotropically, and that the change in dimension will
specimen is placed in a dry chamber. A selected solvent is
be uniform in all directions. This technique avoids uncertainty
chosen according to the Flory network theory and is introduced
induced by solvent evaporation or temperature change.
into the chamber. The chamber is heated to the reference
1.3 The values stated in SI units are to be regarded as
temperature. The sample height is monitored as a function of
standard. No other units of measurement are included in this
time until steady state (equilibrium) is achieved. The swell
standard.
ratio is calculated from the final steady state (equilibrium)
height and the initial height.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
5. Significance and Use
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
5.1 This test method is designed to produce data indicative
bility of regulatory limitations prior to use.
of the degree of crosslinking in ultra high molecular weight
polyethylene that has been crosslinked chemically or by
2. Referenced Documents
ionizing radiation.
2
2.1 ASTM Standards:
5.2 The results are sensitive to the test temperature, solvent,
D2765 Test Methods for Determination of Gel Content and
and method used. For the comparison of data between
Swell Ratio of Crosslinked Ethylene Plastics
institutions, care must be taken to have the same test conditions
E691 Practice for Conducting an Interlaboratory Study to
and reagents.
Determine the Precision of a Test Method
5.3 The data can be used for dose uniformity analysis,
fundamental research, and quality assurance testing.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
6. Apparatus
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
6.1 The apparatus shall include any device that allows a
Current edition approved Oct. 1, 2016. Published October 2016. Originally
non-invasive measurement of the change in one dimension of
approved in 2002. Last previous edition approved in 2008 as F2214 – 02 (2008).
DOI: 10.1520/F2214-16. the sample as it swells in the solvent. This measurement could
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
include, but is not limited to:
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6.1.1 Mechanical measurements, such as linear variable
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. displacement transducers (LVDTs).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2214 − 16
FIG. 1 Marked Measurement Direction Before (a) and After (b) Swelling
6.1.1.1 If a mechanical probe is used, it must be constructed 7.2 Anti-oxidant, 2,2'-methylene-bis (4-methyl-6-tertiary
3
of a material that exhibits little thermal expansion, such as butyl phenol).
quartz or ceramic.
8. Safety Precautions
6.1.2 Optical
...
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