ASTM F2381-19
(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
4.1 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.
4.2 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.
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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 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.
General Information
Relations
Buy Standard
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: F2381 − 19
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 Determine the Precision of a Test Method
E1421 Practice for Describing and Measuring Performance
1.1 This test method describes the measurement of the
of Fourier Transform Mid-Infrared (FT-MIR) Spectrom-
number of trans-vinylene groups in ultra-high molecular
eters: Level Zero and Level One Tests
weight polyethylene (UHMWPE) intended for use in medical
F2102 Guide for Evaluating the Extent of Oxidation in
implants. The material is analyzed by infrared spectroscopy.
Polyethylene Fabricated Forms Intended for Surgical
1.2 This test method is based on Guide F2102.
Implants
1.3 The applicability of the infrared method has been
3. Terminology
demonstrated in other literature reports. This particular
3.1 Definitions:
method, using the intensity (area) of the C-H absorption
-1
centered at 1370 cm to normalize for the sample’s thickness, 3.1.1 trans-vinylene index (TVI)—trans-vinylene index is
defined as the ratio of the area of the absorption peak centered
will be validated by an Interlaboratory Study (ILS) conducted
-1
according to Practice E691. near 965 cm to the area of the absorption peak centered near
-1
1370 cm .
1.4 The values stated in SI units are to be regarded as
3.1.2 depth locator (DL)—measurement of the distance
standard. No other units of measurement are included in this
fromthearticularsurface,orsurfaceofinterest,thataspectrum
standard.
was collected and a corresponding TVI calculated.
1.5 This standard does not purport to address all of the
3.1.3 trans-vinylene index profile—trans-vinylene index
safety concerns, if any, associated with its use. It is the
profile is defined as the graphical representation of variation of
responsibility of the user of this standard to establish appro-
the sample’s trans-vinylene index with distance from its
priate safety, health, and environmental practices and deter-
articular surface or the surface of interest.This is a plot ofTVI
mine the applicability of regulatory limitations prior to use.
versus DL. Typically, the graph will show the profile through
1.6 This international standard was developed in accor-
the entire thickness of the sample.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4. Significance and Use
Development of International Standards, Guides and Recom-
4.1 Published literature shows that the yield of radiolytic
mendations issued by the World Trade Organization Technical
reactions that occur during radiation treatment increases with
Barriers to Trade (TBT) Committee.
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
lesser extent by the recombination of two adjacent alkyl free
radicals that reside on the same chain.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
4.3 Previous work generated calibration curves of trans-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
vinylene absorption area as a function of absorbed radiation
Current edition approved Oct. 1, 2019. Published November 2019. Originally
dose, yielding a linear relationship for both gamma- and
approved 2004. Last previous edition approved in 2010 as F2381–10. DOI:
electron beam-irradiated polyethylene.
10.1520/F2381-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.4 This data can be used to determine received dose as a
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
function of position, assuming a calibration curve (TVI versus
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. radiation dose level) is known for the particular material and
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: F2381 − 10 F2381 − 19
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
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 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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:
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1421 Practice for Describing and Measuring Performance of Fourier Transform Mid-Infrared (FT-MIR) Spectrometers: Level
Zero and Level One Tests
F2102 Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
3. Terminology
3.1 Definitions:
3.1.1 trans-vinylene index (TVI)—a trans-vinylene index is defined as the ratio of the area of the absorption peak centered near
-1 -1
965 cm to the area of the absorption peak centered near 1370 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 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.
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 June 1, 2010Oct. 1, 2019. Published July 2010November 2019. Originally approved 2004. Last previous edition approved in 20042010 as
F2381–04.–10. DOI: 10.1520/F2381-10.10.1520/F2381-19.
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 ----------------------
F2381 − 19
4.2 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.
4.3 Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose,
yielding a line
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.