1.1 本指南涵盖了广泛交联超高分子量聚乙烯（UHMWPE）材料（预制形式），这些材料从满足规范所有要求的原始树脂粉末和固结形式开始生产 F648 . 1.2 本指南不涵盖仅接受气体等离子体、环氧乙烷或小于40 kGy电离辐射处理的超高分子量聚乙烯的制造形式，即仅通过历史灭菌方法处理的材料。 1.3 本指南仅适用于由电离辐射的γ和电子束源广泛交联的超高分子量聚乙烯材料。 1.4 这些机械性能与 体内 制造形式的性能尚未确定。虽然趋势是显而易见的，但聚合物结构的特性和聚合物设计关系还不清楚。这些机械测试经常用于评估制造过程的再现性，并适用于不同材料的比较研究。 1.5 以下预防性警告仅适用于试验方法部分第节 5. ，在本指南中: 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、健康和环境实践，并确定监管限制的适用性。 1.6 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 extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648 . 1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods. 1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. 1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials. 1.5 The following precautionary caveat pertains only to the test method portion, Section 5 , of this guide: 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. 1.6 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.