ASTM F2026-08
(Specification)Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ABSTRACT
This specification covers polyetheretherketone (PEEK) polymer in virgin forms as 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. The PEEK polymer in the scope of this specification is a pure semicrystalline homopolymer consisting of phenylene rings connected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain. Its polymeric structure is defined by the repeating unit EEK. 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 shall be evaluated using appropriate test methods such as US Pharmacopeia test (infrared spectroscopy, viscosity measurements, and total heavy metal content (as lead)), and differential scanning calorimetry. 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. The properties which shall be evaluated are the following: density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength. The biocompatibility of PEEK polymers is also detailed.
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.
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Designation: F2026 – 08
Standard Specification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant
1
Applications
This standard is issued under the fixed designation F2026; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification covers polyetheretherketone (PEEK) 2.1 ASTM Standards:
polymer in virgin forms as supplied by a vendor (pellets, D149 Test Method for Dielectric Breakdown Voltage and
powder, and so forth). It provides requirements and associated Dielectric Strength of Solid Electrical Insulating Materials
test methods for these thermoplastics when they are to be used at Commercial Power Frequencies
in the manufacture of intracorporeal devices such as surgical D256 Test Methods for Determining the Izod Pendulum
implants or components of surgical or dental devices. Impact Resistance of Plastics
1.2 As with any material, some characteristics may be D570 Test Method for Water Absorption of Plastics
altered by the processing techniques (molding, extrusion, D638 Test Method for Tensile Properties of Plastics
machining, assembly, sterilization, and so forth) required for D648 Test Method for Deflection Temperature of Plastics
the production of a specific part or device. Therefore, proper- Under Flexural Load in the Edgewise Position
ties of fabricated forms of these polymers should be evaluated D695 Test Method for Compressive Properties of Rigid
using test methods which are appropriate to ensure safety and Plastics
efficacy as agreed upon by the vendor, purchaser, and regulat- D696 Test Method for Coefficient of Linear Thermal Ex-
ing bodies. pansion of Plastics Between Ø30°C and 30°C with a
1.3 The properties included in this specification are those Vitreous Silica Dilatometer
applicable for PEEK polymers only. Indicated properties are D790 Test Methods for Flexural Properties of Unreinforced
for injection molded forms. Fabricated forms, material or and Reinforced Plastics and Electrical Insulating Materials
forms containing colorants, fillers, processing aids, or other D792 Test Methods for Density and Specific Gravity (Rela-
additives, as well as polymer blends which contain PEEK, or tive Density) of Plastics by Displacement
reclaimed materials, are not covered by this specification. D955 Test Method of Measuring Shrinkage from Mold
1.4 This specification is designed to recommend physical, Dimensions of Thermoplastics
chemical, and biological test methods to establish a reasonable D1238 Test Method for Melt Flow Rates of Thermoplastics
level of confidence concerning the performance of virgin by Extrusion Plastometer
PEEK polymers for use in medical implant devices. The D1505 Test Method for Density of Plastics by the Density-
properties listed should be considered in selecting material(s) Gradient Technique
3
in accordance with the specific end-use requirements. D1898 Practice for Sampling of Plastics
1.5 When evaluating material in accordance with this speci- D3417 Test Method for Enthalpies of Fusion and Crystal-
fication, hazardous materials, operations, and equipment may lization of Polymers by Differential Scanning Calorimetry
3
be involved. This standard does not purport to address all of (DSC)
the safety concerns, if any, associated with its use. It is the D3418 Test Method for Transition Temperatures and En-
responsibility of the user of this standard to establish appro- thalpies of Fusion and Crystallization of Polymers by
priate safety and health practices and determine the applica- Differential Scanning Calorimetry
bility of regulatory limitations prior to use. D4000 Classification System for Specifying Plastic Materi-
als
1
This specification is under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.11 on Polymeric Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Aug. 1, 2008. Published September 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2000. Last previous edition approved in 2007 as F2026 – 07a. DOI: the ASTM website.
3
10.1520/F2026-08. Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2026 – 08
F748 Practice for Selecting Generic Biological Test Meth- 5. Properties
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ods for Materials and Devices
5.1 The infra
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This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2026–07a Designation: F 2026 – 08
Standard Specification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant
1
Applications
This standard is issued under the fixed designation F 2026; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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
injectionmoldedforms.Fabricatedforms,materialorformscontainingcolorants,fillers,processingaids,orotheradditives,aswell
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
2
2.1 ASTM Standards:
D 149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at
Commercial Power Frequencies
D 256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D 570 Test Method for Water Absorption of Plastics
D 638 Test Method for Tensile Properties of Plastics
D 648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D 695 Test Method for Compressive Properties of Rigid Plastics
D 696 Test Method for Coefficient of Linear Thermal Expansion of Plastics Between 30C and 30C with a Vitreous Silica
Dilatometer
D 790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D 792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D 955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D 1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D 1505 Test Method for Density of Plastics by the Density-Gradient Technique
3
D 1898 Practice for Sampling of Plastics
D 3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec.Aug. 1, 2007.2008. Published December 2007.September 2008. Originally approved in 2000. Last previous edition approved in 2007 as
´1
F2026–07 . F 2026 – 07a.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2026–08
D 3418 Test Method for Transition T
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