【国外标准】 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

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.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 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.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 PeakFIG. 2 FTIR Spectra Showing the Carbonyl Absorption BandsNOTE 1: Note 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).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.1.5 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.