ASTM F2026-16 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

This standard covers polyetheretherketone (PEEK) polymer in unprocessed forms as supplied by a vendor (pellets, powders, fabricated forms, etc.). It provides the requirements and related 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.

The properties in this standard are only those that apply to PEEK polymers. Specified specifications are for fabricated forms. Materials or forms containing colorants, fillers, processing aids or other additives as well as polymer blends containing PEEK or recycled materials are not covered by this specification.

This standard is designed to recommend physical, chemical and biological testing methods to establish a reasonable level of confidence in the performance of pure PEEK polymers for use in medical implant devices.

Hazardous materials, processes and equipment may be involved when evaluating material to this specification. This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices prior to use and to determine the applicability of regulatory restrictions.

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