ASTM F2565-06 Standard Guide for Forms Made of Comprehensive Irradiation Crosslinked Ultra High Molecular Weight Polyethylene for Surgical Implant Applications

This guide covers comprehensive cross-linked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) produced starting from pure resin powders and consolidated forms that meet all the requirements of Test Method F 648.

This guide does not cover fabricated forms of ultra-high molecular weight polyethylene with only gas plasma, ethylene oxide, or materials that have received less than 40 kGy of ionizing radiation therapy, i.e. materials that have only been treated with past sterilization methods. This guide deals only with UHMWPE materials extensively crosslinked with gamma and electron beam sources of ionizing radiation.

Specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While the trends are clear, the specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the repeatability of a manufacturing procedure and are applicable to comparative studies of different materials.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

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