1.1 本指南涵盖了一种测量医用植入物用HDPE均聚物和超高分子量聚乙烯（UHMWPE）中存在的相对氧化程度的方法。材料通过红外光谱进行分析。羰基吸收的强度（面积）（>C=O）集中在1720 cm附近 -1 与材料中存在的化学结合氧的数量有关。其他形式的化学结合氧（C-O-C、C-O-O-C、C-O-H等）不包含在本指南中。 1.2 虽然本指南可为研究者提供一种方法来比较各种超高分子量聚乙烯样品中羰基氧化的相对程度，但人们认识到，其他形式的化学结合氧可能是这些材料特性的重要贡献者。 1.3 许多文献报道证明了红外方法的适用性。这是一种特殊的方法，使用中心位于1370cm附近的C-H吸收强度（面积） -1 根据实践进行的实验室间研究（ILS）验证了标准化样品厚度 E691 . 图1 氧化超高分子量聚乙烯的典型FTIR光谱，显示了基于1370厘米归一化的面积氧化指数的定义 -1 峰 图2 显示羰基吸收带的FTIR光谱 注1: 注意，两种试剂都有效地提取了脂质（脂质吸收峰的中心约为1740 cm） -1 ). 胫骨嵌件由高度交联和重熔的UHMWPE制成，然后在EtO气体中进行末端灭菌 （参考1） . 1.4 以下预防性警告仅适用于试验方法部分第节 5. ，本规范: 本标准可能涉及危险材料、操作和设备。本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管要求的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

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 Peak FIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands Note 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.