ISO DIS 5834-1

Description / Abstract: This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.

It is not applicable to finished products.

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.