1 Scope

This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants.

This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.