Resumen:
The document specifies the requirements and corresponding test methods for moulded forms made from ultra-high molecular weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It does not apply to direct moulded or finished products.
Das Dokument legt die Anforderungen und die anzuwendenden Prüfmethoden für Halbzeuge aus ultrahochmolekularem Polyethylen (UHMW-PE) fest, die für die Herstellung von chirurgischen Implantaten vorgesehen sind. Es ist nicht anwendbar für formverpresste Produkte oder Endprodukte.
Keywords:
Ash contents, Castings, Delivery conditions, Density, Determination of content, Dimensions, Elongation at break, Fittings, Impact value, Implants (surgical), Labelling, Labelling (process), Marking, Materials, Materials specification, Medical equipment, Medical sciences, PE, PE-UHMW, Physical properties, Plastics, Polyethylene, Powder, Properties, Semi-finished products, Specification (approval), Specifications, Surgery, Surgical implants, Tear strength, Tensile strength, Testing, Testing conditions, Tests, Titanium, UHMWPE, UHMWPE-Mouldings, Ultra high molecular, Units, Wear, Yield stress