1.1 This standard outlines the requirements for polyetheretherketone (PEEK) polymers in their virgin and fabricated forms, including pellets, granules, powder, and filaments used in additive manufacturing. The specifications cover the thermoplastics’ use in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.

1.2 The properties listed in this standard pertain exclusively to PEEK polymers. The indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PEEK, or reclaimed materials, are not included in this standard.

1.3 This standard aims to provide physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for medical implant devices.

1.4 Values stated in SI units are considered standard and exclusive to this standard. No other units of measurement are mentioned.