ASTM F2820-12
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

Standard No.

ASTM F2820-12

Release Date

2012

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2820-12(2021)e1

Latest

ASTM F2820-12(2021)e1

Scope

1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, 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 As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) 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. With reduced crystallinity, certain polymers have been shown to be more susceptible to environmental stress cracking. Depending upon the implant application, the end user should characterize the material for environmental stress cracking resistance.

1.3 The properties included in this specification are those applicable for PEKK polymers only. Indicated properties are for fabricated forms. Fabricated forms and materials containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEKK, 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 PEKK 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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 F2820-12 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 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
• ISO 604 Plastics - Determination of compressive properties
• ISO 9001 Quality management systems - Requirements [Spanish version]

ASTM F2820-12 history

• 2021 ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 2012 ASTM F2820-12 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications