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ASTM F2102-01e1

(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 describes 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 method.
1.2 Although this method 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 E691.
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

Status
Historical
Publication Date
09-May-2001
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F2102-01 - Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
Effective Date
10-May-2001
Replaced By
ASTM F2102-06 - Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
Effective Date
01-May-2006
Referred By
ASTM F2977-20 - Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
Effective Date
10-May-2001
Referred By
ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Effective Date
10-May-2001
Referred By
ASTM F2381-19 - Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
Effective Date
10-May-2001
Referred By
ASTM F3336-22 - Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
Effective Date
10-May-2001
Referred By
ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
Effective Date
10-May-2001
Referred By
ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
Effective Date
10-May-2001

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ASTM F2102-01e1 - Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical ImplantsASTM F2102-01e1 - Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
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ASTM F2102-01e1 - Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
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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
e1
Designation: F 2102 – 01
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
e NOTE—Section 4.1.1 was editorially corrected in October 2001.
1. Scope 3. Terminology
1.1 This guide describes a method for the measurement of 3.1 Definitions:
the relative extent of oxidation present in ultra-high-molecular- 3.1.1 bulk oxidation index (BOI)—a sample’s bulk oxida-
weight polyethylene (UHMWPE) intended for use in medical tion index (BOI) is the average of the oxidation indices
implants. The material is analyzed by infrared spectroscopy. collected over a 500-µm section at the center of the sample.
The intensity (area) of the carbonyl absorptions (>C=O) 3.1.1.1 Discussion—Typically, this is a plateau region with
-1
centered near 1720 cm is related to the amount of chemically the smallest oxidation indices.
bound oxygen present in the material. Other forms of chemi- 3.1.1.2 Discussion—For samples less than about 8 to 10
cally bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) mm thick, this central region may display the sample’s highest
are not captured by this method. oxidation indices, depending on its state of oxidation.
1.2 Althoughthismethodmaygivetheinvestigatorameans 3.1.2 depth locator (DL)—a measurement of the distance
to compare the relative extent of carbonyl oxidation present in fromthearticularsurface,orsurfaceofinterest,thataspectrum
variousUHMWPEsamples,itisrecognizedthatotherformsof was collected and a corresponding OI calculated.
chemically bound oxygen may be important contributors to 3.1.3 oxidation index (OI)—an oxidation index (OI) is
these materials’ characteristics. defined as the ratio of the area of the absorption peak(s)
-1
1.3 The applicability of the infrared method has been between 1650 and 1850 cm to the area of the absorption
-1
demonstrated by many literature reports. This particular peak(s) between 1330 and 1396 cm , as shown in Fig. 1.
method, using the intensity (area) of the C-H absorption 3.1.4 oxidation index profile—an oxidation index profile is
-1
centered near 1370 cm to normalize for the sample’s thick- the graphical representation of variation of the sample’s
ness, has been validated by an Interlaboratory Study (ILS) oxidation index with distance from its articular surface or the
conducted according to Practice E 691. surface of interest.This is a plot of an OI versus DL.Typically,
1.4 The following precautionary caveat pertains only to the the graph will show the profile through the entire thickness of
test method portion, Section 5, of this specification: This the sample.
standard may involve hazardous materials, operations, and 3.1.5 surface oxidation index (SOI)—a sample’s surface
equipment. This standard does not purport to address all of the oxidation index (SOI) is the average of the oxidation indices
safety concerns, if any, associated with its use. It is the fromthesample’sarticularsurface,orthesurfaceofinterest,to
responsibility of the user of this standard to establish appro- a depth of 3-mm subsurface.
priate safety and health practices and determine the applica-
4. Apparatus
bility of regulatory requirements prior to use.
4.1 Infrared Spectrometer:
2. Referenced Documents
4.1.1 A calibrated infrared spectrometer capable of record-
2.1 ASTM Standards: ing a transmission absorption spectrum over the range of about
-1
E 691 Practice for Conducting an Interlaboratory Study to 1200 to about 2000 cm using about 200-µm-thick films at a
-1
2
Determine the Precision of a Test Method resolution of 4 cm and an aperture of about 200 by 200 µm.
4.1.1.1 Othermodesofcollection(thatis,percentreflection,
attenuated total reflection (ATR), and so forth) and aperture
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
and increment sizes may be used to generate the sample’s
Surgical Materials and Devices and is the direct responsibility of Subcommittee
absorption spectrum provided they can be demonstrated to
F04.15 on Material Test Methods.
Current edition approved May 10, 2001. Published June 2001.
2
Annual Book of ASTM Standards, Vol 14.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
e1
F2102–01
from the articular surface, or surface of interest, across the
width of the film to the opposite surface.
5.3.2.1 Larger incr
...

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4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off