ASTM F2381-10
(Test Method)Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
SIGNIFICANCE AND USE
Published literature shows that the yield of radiolytic reactions that occur during radiation treatment increases with radiation dose level. Measurement of the products of these reactions can be used as an internal dosimeter.
Trans-vinylene unsaturations are formed during ionization treatment by abstraction of a hydrogen molecule, and to a lesser extent by the recombination of two adjacent alkyl free radicals that reside on the same chain.
Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose, yielding a linear relationship for both gamma- and electron beam-irradiated polyethylene.
This data can be used to determine received dose as a function of position, assuming a calibration curve (TVI versus radiation dose level) is known for the particular material and radiation conditions used, and can be used to determine uniformity of dose level in irradiated polyethylene.
SCOPE
1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2 This test method is based on Guide F2102.
1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm-1 to normalize for the sample’s thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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: F2381 − 10
Standard Test Method for
Evaluating Trans-Vinylene Yield in Irradiated Ultra-High
Molecular Weight Polyethylene Fabricated Forms Intended
1
for Surgical Implants by Infrared Spectroscopy
This standard is issued under the fixed designation F2381; 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 Polyethylene Fabricated Forms Intended for Surgical
Implants
1.1 This test method describes the measurement of the
number of trans-vinylene groups in ultra-high molecular
3. Terminology
weight polyethylene (UHMWPE) intended for use in medical
3.1 Definitions:
implants. The material is analyzed by infrared spectroscopy.
3.1.1 trans-vinylene index (TVI)—a trans-vinylene index is
1.2 This test method is based on Guide F2102.
defined as the ratio of the area of the absorption peak centered
-1
near 965 cm to the area of the absorption peak centered near
1.3 The applicability of the infrared method has been
-1
1370 cm .
demonstrated in other literature reports. This particular
method, using the intensity (area) of the C-H absorption
3.1.2 depth locator (DL)—a measurement of the distance
-1
centered at 1370 cm to normalize for the sample’s thickness,
fromthearticularsurface,orsurfaceofinterest,thataspectrum
will be validated by an Interlaboratory Study (ILS) conducted
was collected and a corresponding TVI calculated.
according to Practice E691.
3.1.3 trans-vinylene index profile—a trans-vinylene index
1.4 The values stated in SI units are to be regarded as
profile is defined as the graphical representation of variation of
standard. No other units of measurement are included in this
the sample’s trans-vinylene index with distance from its
standard.
articular surface or the surface of interest.This is a plot ofTVI
versus DL. Typically, the graph will show the profile through
1.5 This standard does not purport to address all of the
the entire thickness of the sample.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Significance and Use
priate safety and health practices and determine the applica-
4.1 Published literature shows that the yield of radiolytic
bility of regulatory limitations prior to use.
reactions that occur during radiation treatment increases with
radiation dose level. Measurement of the products of these
2. Referenced Documents
reactions can be used as an internal dosimeter.
2
2.1 ASTM Standards:
4.2 Trans-vinylene unsaturations are formed during ioniza-
E691 Practice for Conducting an Interlaboratory Study to
tion treatment by abstraction of a hydrogen molecule, and to a
Determine the Precision of a Test Method
lesser extent by the recombination of two adjacent alkyl free
E1421 Practice for Describing and Measuring Performance
radicals that reside on the same chain.
of Fourier Transform Mid-Infrared (FT-MIR) Spectrom-
eters: Level Zero and Level One Tests
4.3 Previous work generated calibration curves of trans-
F2102 Guide for Evaluating the Extent of Oxidation in
vinylene absorption area as a function of absorbed radiation
dose, yielding a linear relationship for both gamma- and
electron beam-irradiated polyethylene.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
4.4 This data can be used to determine received dose as a
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
function of position, assuming a calibration curve (TVI versus
F04.15 on Material Test Methods.
radiation dose level) is known for the particular material and
CurrenteditionapprovedJune1,2010.PublishedJuly2010.Originallyapproved
radiation conditions used, and can be used to determine
2004. Last previous edition approved in 2004 as F2381–04. DOI: 10.1520/F2381-
10.
uniformity of dose level in irradiated polyethylene.
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
5. Apparatus
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 5.1 Infrared Spectrometer:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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---------------------- Page: 1 ----------------------
F2381 − 10
5.1.1 A calibrated infrared spectrometer capable of record- been collected) such that the aperture is positioned over the
ing a transmission absorption spectrum over a minimum range first 200 µm of the film starting at the surface of interest.
-1
of 900 to about 2000 cm using about 200 µm-thick film
...
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.
Designation:F2381–04 Designation: F2381 – 10
Standard Test Method for
Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-
Molecular- Weight Polyethylene Fabricated Forms Intended
1
for Surgical Implants by Infrared Spectroscopy
This standard is issued under the fixed designation F2381; 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 the measurement of the number of trans-vinylene groups in ultra-high molecular weight-
weightweight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2 This test method is based on Guide F2102.
1.3 The applicability of the infrared method has been demonstrated in other literature reports.This particular method, using the
-1
intensity (area) of the C-H absorption centered at 1370 cm to normalize for the sample’s thickness, will be validated by an
Interlaboratory Study (ILS) conducted according to Practice E691.
1.4
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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:
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1421 Practice for Describing and Measuring Performance of FourierTransform Mid-Infrared (FT-MIR) Spectrometers: Level
Zero and Level One Tests
F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended
for Surgical Implants
3. Terminology
3.1 Definitions:
3.1.1 trans-vinylene index (TVI)—atrans-vinyleneindexisdefinedastheratiooftheabsorptionpeakareabetween950and980
-1
—a trans-vinylene index is defined as the ratio of the area of the absorption peak centered near 965 cm
cm to the absorption peak area between 1330 and
-1
to the area of the absorption peak centered near 1370 cm
1396 cm .
3.1.2 depth locator (DL)—a measurement of the distance from the articular surface, or surface of interest, that a spectrum was
collected and a corresponding TVI calculated.
3.1.3 trans-vinylene index profile—a trans-vinylene index profile is defined as the graphical representation of variation of the
sample’s trans-vinylene index with distance from its articular surface or the surface of interest. This is a plot of TVI versus DL.
Typically, the graph will show the profile through the entire thickness of the sample.
4. Significance and Use
4.1 Publishedliteratureshowsthattheyieldofradiolyticreactionsthatoccurduringradiationtreatmentincreaseswithradiation
dose level. Measurement of the products of these reactions can be used as an internal dosimeter.
4.2 Trans-vinylene unsaturations are formed during ionization treatment by abstraction of a hydrogen molecule, and to a lesser
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 Materials Test Methods.
Current edition approved Apr. 1, 2004. Published April 2004. DOI: 10.1520/F2381-04.on Material Test Methods.
Current edition approved June 1, 2010. Published July 2010. Originally approved 2004. Last previous edition approved in 2004 as F2381–04. DOI: 10.1520/F2381-10.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2381 – 10
extent by the recombination of two adjacent alkyl free radicals that reside on the same chain.
4.3 Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose,
yielding a linear relationship for both gamma- and electron beam-irradiated polyethylene.
4.4 This data can be used to determine receive
...
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