1.1 本规范涵盖了拟用于外科植入物的与α-生育酚（维生素E）混合的超高分子量聚乙烯（UHMWPE）粉末。 1.2 本规范的要求适用于两种形式的含α-生育酚的超高分子量聚乙烯。一种是在固结前与α-生育酚混合的原始聚合物粉末（第 4. ). 第二种是由这种混合的、含有α-生育酚的粉末制成的任何形式，随后从中生产成品（第 5. ). 本规范不适用于固结后掺杂维生素E的成品或半成品。 1.3 除了与α-生育酚混合外，规范的规定 F648 和 D4020 申请本规范中详细说明的特殊要求用于描述含有α的粉末- 将用于外科植入物的生育酚。本规范涉及材料特性，不适用于包装和灭菌的成品植入物。本规范也不适用于由γ和电子束电离辐射源广泛交联的超高分子量聚乙烯材料。 1.4 以下预防性警告仅适用于预制模板部分，第 5. ，符合本规范。 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。 1.5 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 specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (Vitamin E) intended for use in surgical implants. 1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4 ). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5 ). This specification does not apply to finished or semi-finished products that are doped with Vitamin E after consolidation. 1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F648 and D4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. 1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5 , of this specification. 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. 1.5 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.