Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

Abstract

This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. It lists the properties that should be considered in selecting material(s) in accordance with the specific end-use requirements. This specification also addresses classification, properties, sampling, and biocompatibility.