标准摘要
[中文适用范围]： 本文件规定了用于制造外科植入物的超高分子量聚乙烯（UHMWPE）粉末制成的成型形式（如板材、棒材和近净形棒材）的要求和相应的测试方法。 本文件不适用于有意辐照的成型形式、由UHMWPE与添加剂混合或UHMWPE与不同形式的聚乙烯混合制成的成型形式，以及包装和灭菌的成品植入物。 [外文原描述]： This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants. This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.
英文名称Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms