ASTM F2026-10
(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, fabricated forms, 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 this polymer 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 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.
1.4 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 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.
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Designation:F2026 −10
StandardSpecification 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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope of the safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.1 This specification covers polyetheretherketone (PEEK)
priate safety and health practices and determine the applica-
polymer in virgin forms as supplied by a vendor (pellets,
bility of regulatory limitations prior to use.
powder, fabricated forms, and so forth). It provides require-
ments and associated test methods for these thermoplastics
2. Referenced Documents
when they are to be used in the manufacture of intracorporeal
2
2.1 ASTM Standards:
devices such as surgical implants or components of surgical or
D149Test Method for Dielectric Breakdown Voltage and
dental devices.
DielectricStrengthofSolidElectricalInsulatingMaterials
1.2 As with any material, some characteristics may be
at Commercial Power Frequencies
altered by the processing techniques (molding, extrusion,
D256Test Methods for Determining the Izod Pendulum
machining, assembly, sterilization, and so forth) required for
Impact Resistance of Plastics
the production of a specific part or device. Therefore, proper-
D570Test Method for Water Absorption of Plastics
ties of fabricated forms of this polymer should be evaluated
D638Test Method for Tensile Properties of Plastics
using test methods which are appropriate to ensure safety and
D648Test Method for Deflection Temperature of Plastics
efficacy as agreed upon by the vendor, purchaser, and regulat-
Under Flexural Load in the Edgewise Position
ing bodies.
D695Test Method for Compressive Properties of Rigid
1.3 The properties included in this specification are those
Plastics
applicable for PEEK polymers only. Indicated properties are
D696TestMethodforCoefficientofLinearThermalExpan-
for fabricated forms. Materials or forms containing colorants,
sion of Plastics Between −30°C and 30°C with aVitreous
fillers, processing aids, or other additives, as well as polymer
Silica Dilatometer
blends which contain PEEK, or reclaimed materials, are not
D790Test Methods for Flexural Properties of Unreinforced
covered by this specification.
and Reinforced Plastics and Electrical Insulating Materi-
als
1.4 This specification is designed to recommend physical,
D792Test Methods for Density and Specific Gravity (Rela-
chemical, and biological test methods to establish a reasonable
tive Density) of Plastics by Displacement
level of confidence concerning the performance of virgin
D955Test Method of Measuring Shrinkage from Mold
PEEK polymers for use in medical implant devices. The
Dimensions of Thermoplastics
properties listed should be considered in selecting material(s)
D1238Test Method for Melt Flow Rates of Thermoplastics
in accordance with the specific end-use requirements.
by Extrusion Plastometer
1.5 The values stated in SI units are to be regarded as
D1505Test Method for Density of Plastics by the Density-
standard. No other units of measurement are included in this
Gradient Technique
standard.
3
D1898Practice for Sampling of Plastics (Withdrawn 1998)
1.6 When evaluating material in accordance with this
D3417Test Method for Enthalpies of Fusion and Crystalli-
specification, hazardous materials, operations, and equipment
zation of Polymers by Differential Scanning Calorimetry
3
maybeinvolved. This standard does not purport to address all
(DSC) (Withdrawn 2004)
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2010. Published September 2010. Originally the ASTM website.
3
approved in 2000. Last previous edition approved in 2008 as F2026–08. DOI: The last approved version of this historical standard is referenced on
10.1520/F2026-10. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2026−10
D3418Test Method for Transition Temperatures and En- 4. Classification
thalpies of Fusion and Crystallization of Polymers by
4.1 The
...
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:F2026–08 Designation: F2026 – 10
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
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder,
fabricated forms, 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 polymersthis polymer 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 fabricated forms. Fabricated forms, materialMaterials 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
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at
Commercial Power Frequencies
D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D570 Test Method for Water Absorption 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
D696 Test Method for Coefficient of Linear Thermal Expansion of Plastics Between 30C and 30C with a Vitreous Silica
Dilatometer
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
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 Aug.Sept. 1, 2008.2010. Published September 2008.2010. Originally approved in 2000. Last previous edition approved in 20072008 as
F2026–07a.F2026 – 08. DOI: 10.1520/F2026-108.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2026 – 10
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D1898 Pra
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