ASTM F2026-02
(Specification)Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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 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: F 2026 – 02
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D149 Test Method for Dielectric Breakdown Voltage and
Dielectric Strength of Electrical Insulating Materials at
1.1 This specification covers polyetheretherketone (PEEK)
2
Commercial Power Frequencies
polymer in virgin forms as supplied by a vendor (pellets,
D256 Test Method for Determining the Izod Pendulum
powder, and so forth). It provides requirements and associated
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Impact Resistance of Plastics
test methods for these thermoplastics when they are to be used
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D570 Test Method for Water Absorption of Plastics
in the manufacture of intracorporeal devices such as surgical
D621 Test Methods for Deformation of Plastics Under
implants or components of surgical or dental devices.
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Load
1.2 As with any material, some characteristics may be
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D638 Test Method for Tensile Properties of Plastics
altered by the processing techniques (molding, extrusion,
D648 Test Method for Deflection Temperature of Plastics
machining, assembly, sterilization, and so forth) required for
3
Under Flexural Load
the production of a specific part or device. Therefore, proper-
D695 Test Method for Compressive Properties of Rigid
ties of fabricated forms of these polymers should be evaluated
3
Plastics
using test methods which are appropriate to ensure safety and
D696 Test Method for Coefficient of Linear Thermal Ex-
efficacy as agreed upon by the vendor, purchaser, and regulat-
pansion of Plastics Between −30°C and 30°C with a
ing bodies.
3
Vitreous Silica Dilatometer
1.3 The properties included in this specification are those
D790 TestMethodsforFlexuralPropertiesofUnreinforced
applicable for PEEK polymers only. Indicated properties are
and Reinforced Plastics and Electrical Insulating Materi-
for injection molded forms. Fabricated forms, material or
3
als
forms containing colorants, fillers, processing aids, or other
D792 TestMethodsforDensityandSpecificGravity(Rela-
additives, as well as polymer blends which contain PEEK, or
3
tive Density) of Plastics by Displacement
reclaimed materials, are not covered by this specification.
D955 Test Method for Measuring Shrinkage from Mold
1.4 This specification is designed to recommend physical,
3
Dimensions of Thermoplastics
chemical, and biological test methods to establish a reasonable
D1238 Test Method for Flow Rates of Thermoplastics by
level of confidence concerning the performance of virgin
3
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 in
3
Gradient Technique
accordance with the specific end-use requirements.
5
D1898 Practice for Sampling of Plastics
1.5 Whenevaluatingmaterialinaccordancewiththisspeci-
D3417 Test Method for Enthalpies of Fusion and Crystal-
fication, hazardous materials, operations, and equipment may
lization of Polymers by Differential Scanning Calorimetry
be involved. This standard does not purport to address all of
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(DSC)
the safety concerns, if any, associated with its use. It is the
D3418 Test Method for Transition Temperatures of Poly-
responsibility of the user of this standard to establish appro-
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mers by Differential Scanning Calorimetry
priate safety and health practices and determine the applica-
D4000 Classification System for Specifying Plastic Mate-
bility of regulatory limitations prior to use.
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rials
2. Referenced Documents
F748 Practice for Selecting Generic Biological Test Meth-
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ods for Materials and Devices
2.1 ASTM Standards:
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Annual Book of ASTM Standards, Vol 10.01.
1 3
This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 08.01.
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Medical and Surgical Materials and Devices and is the direct responsibility of Discontinued; see 1993 Annual Book of ASTM Standards, Vol 08.01.
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Subcommittee F04.11 on Polymeric Materials. Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.02.
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Current edition approved Apr. 10, 2002. Published June 2002. Originally Annual Book of ASTM Standards, Vol 08.02.
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published as F2026–00. Last previous edition F2026–00. Annual Book of ASTM Standards, Vol 13.01.
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F2026–02
F1579 Specification for Polyaryletherketone
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