标准摘要
[中文适用范围]： 本文件规定了超高分子量聚乙烯（UHMWPE）模塑形态的评估方法。 UHMWPE模塑形态的评估在常规监测已验证的模塑过程中不需要，因为ISO 5834-2中定义的替代测试方法（如密度和机械性能）已经提供了合理的冗余保证。 本文件不适用于UHMWPE粉末形式，这些在ISO 5834-1中描述。 注：本测试方法的性能要求尚未确定。 [外文原描述]： This document specifies the test method for assessing the morphology of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as defined in ISO 5834-2. The assessment of morphology of UHMWPE moulded forms is not required in routine monitoring of validated moulding process because alternative test methods defined in ISO 5834-2, such as density and mechanical properties, already provide reasonable, redundant assurance of successful consolidation. This document is not applicable to UHMWPE powder forms, which are described in ISO 5834-1. NOTE Performance requirements for this test method have not been established.
英文名称Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method