ASTM F2026-23
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Standard No.

ASTM F2026-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2026-23

Scope

1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. 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 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials 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. 1.3 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. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F2026-23 Referenced Document

• ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
• ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
• ASTM D3418 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
• ASTM D4000 Standard Classification System for Specifying Plastic Materials
• 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*， 2024-04-22 Update
• ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-22 Update
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• 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 1183 Plastics; Methods for determining the density and relative density of non-cellular plastics
• ISO 13485 
• ISO 178 Surface chemical analysis — Secondary ion mass spectrometry — Linearity of intensity scale in single ion counting time-of-flight mass analysers
• ISO 180 Plastics. Determination of Izod impact strength
• ISO 527 Plastics — Determination of tensile properties — Part 5: Test conditions for unidirectional fibre-reinforced plastic composites

ASTM F2026-23 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