ASTM F2026-07e1
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- Standard No.
- ASTM F2026-07e1
- Release Date
- 2007
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2026-07a
- Latest
- ASTM F2026-23
- 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.
ASTM F2026-07e1 Referenced Document
- ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
- ASTM D149 Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
- ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM D1898
- ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
- ASTM D3417 Standard Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
- ASTM D3418 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
- ASTM D4000 Standard Classification System for Specifying Plastic Materials
- ASTM D570 Standard Test Method for Water Absorption of Plastics
- ASTM D638 Standard Test Method for Tensile Properties of Plastics
- ASTM D648 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position*， 2024-04-19 Update
- ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
- ASTM D696 Standard Test Method for Coefficient of Linear Thermal Expansion of Plastics Between -30176C and 30176C With a Vitreous Silica Dilatometer
- ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-19 Update
- ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
- ASTM D955 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
- ASTM F1579 Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 1133 Plastics - Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics; Technical Corrigendum 1
- ISO 1628-1 Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometers - Part 1: General principles
ASTM F2026-07e1 history
- 2023 ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2017 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2016 ASTM F2026-16 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2014 ASTM F2026-14 Standard Specification for Polyetheretherketone 40;PEEK41; Polymers for Surgical Implant Applications
- 2012 ASTM F2026-12 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2010 ASTM F2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2008 ASTM F2026-08 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2007 ASTM F2026-07a Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2007 ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2007 ASTM F2026-07 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2002 ASTM F2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 2002 ASTM F2026-00 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
