【国外标准】 Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012)

This specification covers polyetherketoneetherketoneketone (PEKEKK) resins in virgin forms as supplied by a vendor, such as flakes, pellets, blocks, and so forth. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacturing of intracorporeal devices, such as surgical implants or components of surgical or dental devices. The properties of fabricated forms of these resins should be evaluated using test methods that are appropriate to assure safety and efficacy. PEKEKK resins in the scope of this specification are pure semicrystalline homopolymers consisting of phenylene rings connected by either (E) and carbonyl (or ketone, K) groups along the polymer chain.1.1 This specification covers polyetherketoneetherketoneketone (PEKEKK) resins in virgin forms as supplied by a vendor, such as flakes, pellets, blocks, etc. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacturing of intracorporeal devices, such as surgical implants or components of surgical or dental devices.1.2 As with any material, some characteristics may be altered by the processing techniques, such as molding, extrusion, machining, assembly, sterilization, etc. required for the production of a specific part or device; therefore, properties of fabricated forms of these resins should be evaluated using test methods that are appropriate to assure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.1.3 The properties included in this specification are those applicable for PEKEKK resins only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends tht contain PEKEKK, are not covered by this specification.1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKEKK resins for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirement.1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.