ISO DIS 5834-4

Description / Abstract: This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE).

It is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants.

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.