ASTM F2102 - 13

    Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

    Active Standard ASTM F2102 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.01


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    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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and 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 

    Typical FTIR Spectra of Oxidized UHMWPE, Showing the
Definition of an Area-Based Oxidation Index Based on Normalization
Using the 1370-cm Peak
    FIG. 1 Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm -1 Peak
    FTIR Spectra Showing the Carbonyl Absorption Bands
    FIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands
    Note 1Note that both reagents effectively extracted the lipids (the lipid absorption peak is centered at approximately 1740 cm-1). The tibial insert was fabricated from highly crosslinked and remelted UHMWPE followed by terminal sterilization in EtO gas (Ref. 1).
    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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)


    DOI: 10.1520/F2102

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