标准摘要
[中文适用范围]: 本文件规定了研究超高分子量聚乙烯(UHMWPE)模塑制品氧化稳定性的测试方法,该方法与加工和灭菌方法相关。本文件描述了一种实验室方法,用于加速老化取自UHMWPE模塑制品或用于制造外科植入物的制品的试样。试样在高温和高压氧气条件下老化,以加速材料的氧化,从而评估其潜在的长期化学和机械稳定性。 [外文原描述]: This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of specimens taken from UHMWPE moulded forms or forms fabricated from these for use in the manufacture of surgical implants. The specimens are aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.
英文名称Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods after gamma irradiation in air