1. Scope

1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms 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 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 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 which contain PEEK, 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 PEEK 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

D638 Test Method for Tensile Properties of Plastics

D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

D695 Test Method for Compressive Properties of Rigid Plastics

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D1898 Practice for Sampling of Plastics

D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

D4000 Classification System for Specifying Plastic Materials

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

ISO Standards

Other Documents

Keywords

PEEK; polyetheretherketone;

ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials)

DOI: 10.1520/F2026-07

ASTM International is a member of CrossRef.