ASTM F2102-06e1
(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
ABSTRACT
This guide covers method for evaluating the relative extent of oxidation in ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants. Equipments for this method shall include an infrared spectrometer, specimen holder, and microtome. Specimen shall be tested with infrared spectrometer in accordance to the procedure of test specimen preparation, spectrometer setup, and test specimen configuration. Oxidation peak area, normalization peak area, oxidation index, oxidation index depth locator, oxidation index profile, surface oxidation index, bulk oxidation index, and maximum oxidation index shall be calculated from the spectra. Report shall include material information, sample information, spectrometer information, and data analysis information.
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.
1.4 The following precautionary caveat pertains only to the test method portion, Section 5, 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.
General Information
Relations
Standards Content (Sample)
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
´1
Designation:F2102 −06
StandardGuide 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 F2102; 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
´ NOTE—Paragraphs 7.1.4.2 and 8.1 were editorially corrected in July 2006.
1. Scope 2. Referenced Documents
2
1.1 This guide covers a method for the measurement of the 2.1 ASTM Standards:
relative extent of oxidation present in ultra-high-molecular- E691 Practice for Conducting an Interlaboratory Study to
weight polyethylene (UHMWPE) intended for use in medical Determine the Precision of a Test Method
implants. The material is analyzed by infrared spectroscopy.
3. Terminology
The intensity (area) of the carbonyl absorptions (>C=O)
-1
centered near 1720 cm is related to the amount of chemically
3.1 Definitions:
bound oxygen present in the material. Other forms of chemi-
3.1.1 bulk oxidation index (BOI)—a sample’s bulk oxida-
cally bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth)
tion index (BOI) is the average of the oxidation indices
are not captured by this guide.
collected over a 500-µm section at the center of the sample.
3.1.1.1 Discussion—Typically, this is a plateau region with
1.2 Although this guide may give the investigator a means
the smallest oxidation indices.
to compare the relative extent of carbonyl oxidation present in
3.1.1.2 Discussion—Forsampleslessthanabout8to10mm
variousUHMWPEsamples,itisrecognizedthatotherformsof
thick, this central region may display the sample’s highest
chemically bound oxygen may be important contributors to
oxidation indices, depending on its state of oxidation.
these materials’ characteristics.
3.1.2 depth locator (DL)—a measurement of the distance
1.3 The applicability of the infrared method has been
fromthearticularsurface,orsurfaceofinterest,thataspectrum
demonstrated by many literature reports. This particular
was collected and a corresponding OI calculated.
method, using the intensity (area) of the C-H absorption
-1
centered near 1370 cm to normalize for the sample’s 3.1.3 oxidation index (OI)—an oxidation index (OI) is
defined as the ratio of the area of the carbonyl absorption
thickness,hasbeenvalidatedbyanInterlaboratoryStudy(ILS)
-1
conducted according to Practice E691. peak(s) centered near 1720 cm to the area of the absorption
-1
peak(s) centered near 1370 cm , as shown in Fig. 1. Note that
1.4 The following precautionary caveat pertains only to the
the peak areas are computed after subtracting out the appro-
test method portion, Section 5, of this specification: This
priate baseline, as further discussed in Section 6.
standard may involve hazardous materials, operations, and
equipment. This standard does not purport to address all of the 3.1.4 oxidation index profile—an oxidation index profile is
the graphical representation of variation of the sample’s
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- oxidation index with distance from its articular surface or the
surface of interest.This is a plot of an OI versus DL.Typically,
priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use. the graph will show the profile through the entire thickness of
the sample.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2006. Published May 2006. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
´1
approved in 2001. Last previous edition approved in 2001 as F2102 – 01 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2102-06E01. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
´1
F2102−06
5.2 Preparation of Test Specimen:
5.2.1 Using a microtome, or other appropriate device, pre-
pare a thin slice of the sample about 200 µm thick.
5.2.2 The slice shall typically be taken near the center of the
sample’s articular surface or the surface of interest.
5.2.3 The orientation of the slice shall typically be perpen-
dicular to the articular surface or the surface of interest.
5.3 Configuration of the Test S
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.