ASTM F2102-06
(Guide)Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
SCOPE
1.1 This guide covers a method for the measurement of the relative extent of oxidation present in ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (>C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide.
1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics.
1.3 The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample's thickness, has been validated by an Interlaboratory Study (ILS) conducted according to Practice E 691.
The following precautionary caveat pertains only to the test method portion, Section , of this specification: This standard may involve 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 requirements prior to use.
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Designation: F 2102 – 06
Standard Guide for
Evaluating the Extent of Oxidation in Ultra-High-Molecular-
Weight Polyethylene Fabricated Forms Intended for Surgical
1
Implants
This standard is issued under the fixed designation F 2102; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope E 691 Practice for Conducting an Interlaboratory Study to
Determine the Precision of a Test Method
1.1 This guide covers a method for the measurement of the
relative extent of oxidation present 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 bulk oxidation index (BOI)—a sample’s bulk oxida-
The intensity (area) of the carbonyl absorptions (>C=O)
-1
tion index (BOI) is the average of the oxidation indices
centered near 1720 cm is related to the amount of chemically
collected over a 500-µm section at the center of the sample.
bound oxygen present in the material. Other forms of chemi-
3.1.1.1 Discussion—Typically, this is a plateau region with
cally bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth)
the smallest oxidation indices.
are not captured by this guide.
3.1.1.2 Discussion—For samples less than about 8 to 10
1.2 Although this guide may give the investigator a means
mm thick, this central region may display the sample’s highest
to compare the relative extent of carbonyl oxidation present in
oxidation indices, depending on its state of oxidation.
variousUHMWPEsamples,itisrecognizedthatotherformsof
3.1.2 depth locator (DL)—a measurement of the distance
chemically bound oxygen may be important contributors to
fromthearticularsurface,orsurfaceofinterest,thataspectrum
these materials’ characteristics.
was collected and a corresponding OI calculated.
1.3 The applicability of the infrared method has been
3.1.3 oxidation index (OI)—an oxidation index (OI) is
demonstrated by many literature reports. This particular
defined as the ratio of the area of the carbonyl absorption
method, using the intensity (area) of the C-H absorption
-1
-1
peak(s) centered near 1720 cm to the area of the absorption
centered near 1370 cm to normalize for the sample’s thick-
-1
peak(s) centered near 1370 cm , as shown in Fig. 1. Note that
ness, has been validated by an Interlaboratory Study (ILS)
the peak areas are computed after subtracting out the appro-
conducted according to Practice E 691.
priate baseline, as further discussed in Section 6.
1.4 The following precautionary caveat pertains only to the
3.1.4 oxidation index profile—an oxidation index profile is
test method portion, Section 5, of this specification: This
the graphical representation of variation of the sample’s
standard may involve hazardous materials, operations, and
oxidation index with distance from its articular surface or the
equipment. This standard does not purport to address all of the
surface of interest.This is a plot of an OI versus DL.Typically,
safety concerns, if any, associated with its use. It is the
the graph will show the profile through the entire thickness of
responsibility of the user of this standard to establish appro-
the sample.
priate safety and health practices and determine the applica-
3.1.5 surface oxidation index (SOI)—a sample’s surface
bility of regulatory requirements prior to use.
oxidation index (SOI) is the average of the oxidation indices
2. Referenced Documents fromthesample’sarticularsurface,orthesurfaceofinterest,to
2
a depth of 3-mm subsurface.
2.1 ASTM Standards:
4. Apparatus
4.1 Infrared Spectrometer:
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
4.1.1 A calibrated infrared spectrometer capable of record-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
ing a transmission absorption spectrum over the range of about
F04.15 on Material Test Methods.
-1
1200 to about 2000 cm using about 200-µm-thick films at a
Current edition approved May 1, 2006. Published May 2006. Originally
e1 -1
approved in 2001. Last previous edition approved in 2001 as F 2102 – 01 .
resolution of 4 cm and an aperture of about 200 by 200 µm.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1.1.1 Othermodesofcollection(thatis,percentreflection,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
attenuated total reflection (ATR), and so forth) and aperture
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. and increment sizes may be used to generate the sample’s
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