1. Scope
1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (pellets, powder, and so forth). 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. 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 polymers should be evaluated using test methods that 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 PEKK polymers only. Indicated properties are for injection-molded forms. Fabricated forms, material, or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PEKK or reclaimed materials 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 PEKK polymers for use in medical implant devices. The properties listed should be considered in selecting material(s) 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.
PEKK materials are being used to manufacture implant devices that are being implanted into humans, and thus, this standard is needed to help control these materials compositions and properties and to assist with the protection of public health.
Keywords
PEKK; polyetherketoneketone
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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