ISO DIS 5834-3

Description / Abstract: This document specifies a test method for investigating the oxidative stability of ultra-high-molecularweight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is 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.

NOTE 1 In the field of medical devices it is common to use quality management systems. One possible and widely used quality management system for medical devices is described in ISO 13485.

NOTE 2 Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.