ASTM F2214-23
(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="ital"> 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 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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Standards Content (Sample)
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 − 23
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 E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
1.1 This test method describes how the crosslink density,
E691 Practice for Conducting an Interlaboratory Study to
molecular weight between crosslinks, and number of repeat
Determine the Precision of a Test Method
units between crosslinks in ultra high molecular weight poly-
ethylene (UHMWPE) crosslinked by ionizing radiation or by
3. Terminology
chemical means can be determined by measuring the swelling
3.1 Definitions of Terms Specific to This Standard:
ratio of samples immersed in o-xylene. Examples of experi-
3.1.1 crosslink density, ν —the theoretical average number
d
mental techniques used to make these measurements are
3
of crosslinks per unit volume [mol/dm ].
discussed herein.
3.1.2 molecular weight between crosslinks, M —the theo-
c
1.2 The test method reported here measures the change in
retical average molecular weight between crosslinks [g/mol].
height of a sample specimen while it is immersed in the
3.1.3 swell ratio, q —the ratio of the volume of the sample
solvent. Volumetric swell ratios assume that the sample is s
in an equilibrium swollen state to its volume in the unswollen
crosslinked isotropically, and that the change in dimension will
state.
be uniform in all directions. This technique avoids uncertainty
induced by solvent evaporation or temperature change.
4. Summary of Test Method
1.3 The values stated in SI units are to be regarded as
4.1 The height of a cubic specimen is measured, and the
standard. No other units of measurement are included in this
specimen is placed in a dry chamber. A selected solvent is
standard.
chosen according to the Flory network theory and is introduced
1.4 This standard does not purport to address all of the into the chamber. The chamber is heated to the reference
safety concerns, if any, associated with its use. It is the
temperature. The sample height is monitored as a function of
responsibility of the user of this standard to establish appro-
time until steady state (equilibrium) is achieved. The swell
priate safety, health, and environmental practices and deter-
ratio is calculated from the final steady state (equilibrium)
mine the applicability of regulatory limitations prior to use.
height and the initial height.
1.5 This international standard was developed in accor-
5. Significance and Use
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 5.1 This test method is designed to produce data indicative
Development of International Standards, Guides and Recom- of the degree of crosslinking in ultra high molecular weight
mendations issued by the World Trade Organization Technical polyethylene that has been crosslinked chemically or by
Barriers to Trade (TBT) Committee. ionizing radiation.
5.2 The results are sensitive to the test temperature, solvent,
2. Referenced Documents
and method used. For the comparison of data between
2
2.1 ASTM Standards:
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
5.3 The data can be used for dose uniformity analysis,
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
fundamental research, and quality assurance testing.
F04.15 on Material Test Methods.
Current edition approved Sept. 1, 2023. Published October 2023. Originally
6. Apparatus
approved in 2002. Last previous edition approved in 2016 as F2214 – 16. DOI:
10.1520/F2214-23.
6.1 The apparatus shall include any device that allows a
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
non-invasive measurement of the change in one dimension of
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
the sample as it swells in the solvent. This measurement could
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. include, but is not limited to:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
-------------
...
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 − 16 F2214 − 23
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 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D2765E177 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene PlasticsPractice for Use
of the Terms Precision and Bias in ASTM Test Methods
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
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 Oct. 1, 2016Sept. 1, 2023. Published October 2016October 2023. Originally approved in 2002. Last previous edition approved in 20082016 as
F2214 – 02 (2008).F2214 – 16. DOI: 10.1520/F2214-16.10.1520/F2214-23.
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 − 23
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 te
...
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