【国外标准】 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

This guide covers extensively irradiation-crosslinked ultra-high molecular weight polyethylene (UHMWPE) fabricated forms for surgical implant applications. Only gamma and electron beam irradiated extensively crosslinked materials are covered by this guide. Chemical composition and physical properties of extensively crosslinked UHMWPE fabricated form shall conform to the requirements of this guide which include ultimate tensile strength, yield strength, elongation, Izod impact strength, ultimate load, fatigue crack propagation, compressive modulus, percent crystallinity, melting temperature, residual free radicals, swell ratio, oxidation index, and t-vinylene content. Biocompatibility of the material shall also be considered when new applications of the material, or modification to the material or physical forms of the materials are being contemplated.1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648.1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.