Standard Specification for Polyetheretherketone (PEEK) Resins for Surgical Implant Applications
|Publication Date:||10 May 2000|
|ICS Code (Surgical instruments and materials):||11.040.30|
1.1 This specification covers polyetheretherketone
1.2 As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these resins should be evaluated using test methods which are appropriate to ensure 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 PEEK resins only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, 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 PEEK resins for use in medical devices. The properties listed should be considered in selecting material in accordance with the specific end-use requirements.
1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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.