ASTM F2026-23

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 (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.

General Information

• Status: Published
• Publication Date: 31-Jul-2023
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Refers: ASTM D648-18 - Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
• Effective Date: 01-Apr-2018
• Refers: ASTM D790-17 - Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM D790-15 - Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
• Effective Date: 01-Dec-2015
• Refers: ASTM D790-15e1 - Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
• Effective Date: 01-Dec-2015
• Refers: ASTM D3418-12 - Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
• Effective Date: 01-Aug-2012
• Refers: ASTM D3418-12e1 - Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
• Effective Date: 01-Aug-2012
• Refers: ASTM D4000-12 - Standard Classification System for Specifying Plastic Materials
• Effective Date: 01-May-2012
• Refers: ASTM D4000-11 - Standard Classification System for Specifying Plastic Materials
• Effective Date: 01-Apr-2011
• Refers: ASTM D1505-10 - Standard Test Method for Density of Plastics by the Density-Gradient Technique
• Effective Date: 01-Jul-2010
• Refers: ASTM D4000-10a - Standard Classification System for Specifying Plastic Materials
• Effective Date: 01-Jul-2010
• Refers: ASTM F748-06(2010) - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Jun-2010
• Refers: ASTM D638-10 - Standard Test Method for Tensile Properties of Plastics
• Effective Date: 15-May-2010
• Refers: ASTM D4000-10 - Standard Classification System for Specifying Plastic Materials
• Effective Date: 01-May-2010
• Refers: ASTM D695-10 - Standard Test Method for Compressive Properties of Rigid Plastics
• Effective Date: 01-Apr-2010

Overview

ASTM F2026-23: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications sets out critical requirements for the use of virgin PEEK polymers in surgical and dental implant devices. Published by ASTM International, this standard delineates the physical, chemical, and biological characteristics of pure semicrystalline PEEK intended for use in the manufacture of high-performance intracorporeal medical devices.

The specification applies solely to virgin forms of PEEK-such as pellets, granules, powder, or filaments used in additive manufacturing-and excludes PEEK formulations containing fillers, colorants, additives, blends, or reclaimed materials. The document provides guidance on appropriate test methods to ensure product safety and efficacy for human implantation.

This standard is essential for manufacturers, regulatory professionals, and quality assurance teams involved in the selection, processing, and evaluation of PEEK biomaterials for surgical implant applications.

Key Topics

Material Scope and Purity Requirements

• Only virgin, unmodified PEEK forms are covered.
• Materials containing additives, blends, or recycled content do not meet this standard.
• Emphasis on chemical composition and purity for safe medical use.

Required Properties and Test Methods

• Properties to be evaluated include density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength.
• Testing must use validated methods such as ASTM D638 (tensile properties), D790 (flexural properties), D256 (impact resistance), D792/D1505 (density), and D3418 (differential scanning calorimetry).
• Total heavy metal content is to be measured according to U.S. Pharmacopeia standards.
• Infrared spectroscopy is used to confirm polymer identity and detect impurities.

Processing Considerations

• The physical and mechanical properties of PEEK can be affected by methods such as molding, extrusion, machining, sterilization, and assembly.
• All fabricated parts should be tested to verify compliance with the specified properties after processing.

Biocompatibility and Quality Systems

• Verifies acceptable biological response for implants based on established biocompatibility assessments such as ISO 10993 and ASTM F748.
• Recommends production in accordance with ISO 13485-certified quality management systems for medical devices.

Applications

ASTM F2026-23 ensures a reliable framework for medical device manufacturers and material suppliers using PEEK in:

• Orthopedic and spinal implants
• Dental devices and prosthetics
• Customized craniofacial or trauma implants
• Additive manufactured implantable devices using PEEK filaments

Adhering to this standard supports regulatory approval pathways by confirming that virgin PEEK meets stringent physical, chemical, and biological safety criteria for surgical implantation. It also provides clarity for raw material selection, product development, and supplier qualification in the medical device industry.

Related Standards

For comprehensive compliance and product development, ASTM F2026-23 references these associated standards and practices:

• ASTM D638: Test Method for Tensile Properties of Plastics
• ASTM D790: Test Methods for Flexural Properties
• ASTM D256: Impact Resistance of Plastics
• ASTM D792, D1505: Methods for Density of Plastics
• ASTM D3418: Transition Temperatures of Polymers
• ASTM D648, D695: Deformation and Compressive Properties
• ASTM F748: Practice for Selecting Generic Biological Test Methods
• ISO 10993: Biological Evaluation of Medical Devices
• ISO 13485: Medical Device Quality Management Systems
• ISO 15309: Differential Scanning Calorimetry for PEEK Implants

Using ASTM F2026-23 in tandem with these referenced test methods and standards ensures that PEEK polymers used in surgical implants deliver the necessary performance, quality, and safety for patients and healthcare providers.

Standards Content (Sample)

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.
Designation: F2026 − 23
Standard Specification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant
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
1.1 This specification covers polyetheretherketone (PEEK) 2.1 ASTM Standards:
polymer in virgin forms (for example, pellets, granules, D256 Test Methods for Determining the Izod Pendulum
powder, filaments used in additive manufacturing) and fabri- Impact Resistance of Plastics
cated forms. It provides requirements and associated test D638 Test Method for Tensile Properties of Plastics
methods for these thermoplastics when they are to be used in D648 Test Method for Deflection Temperature of Plastics
the manufacture of intracorporeal devices such as surgical Under Flexural Load in the Edgewise Position
implants or components of surgical or dental devices. D695 Test Method for Compressive Properties of Rigid
Plastics
1.2 The properties included in this specification are those
D790 Test Methods for Flexural Properties of Unreinforced
applicable for PEEK polymers only. Indicated properties are
and Reinforced Plastics and Electrical Insulating Materi-
for fabricated forms. Materials or forms containing colorants,
als
fillers, processing aids, or other additives, as well as polymer
D792 Test Methods for Density and Specific Gravity (Rela-
blends which contain PEEK, or reclaimed materials, are not
tive Density) of Plastics by Displacement
covered by this specification.
D1505 Test Method for Density of Plastics by the Density-
1.3 This specification is designed to recommend physical,
Gradient Technique
chemical, and biological test methods to establish a reasonable
D3418 Test Method for Transition Temperatures and Enthal-
level of confidence concerning the performance of virgin
pies of Fusion and Crystallization of Polymers by Differ-
PEEK polymers for use in medical implant devices.
ential Scanning Calorimetry
D4000 Classification System for Specifying Plastic Materi-
1.4 The values stated in SI units are to be regarded as
als
standard. No other units of measurement are included in this
standard. F748 Practice for Selecting Generic Biological Test Methods
for Materials and Devices
1.5 When evaluating material in accordance with this
specification, hazardous materials, operations, and equipment
2.2 ISO Standards:
may be involved. This standard does not purport to address all ISO 178 Plastics—Determination of Flexural Properties
of the safety concerns, if any, associated with its use. It is the
ISO 180 Plastics—Determination of Izod Impact Strength
responsibility of the user of this standard to establish appro- ISO 527 Plastics—Determination of Tensile Properties—
priate safety, health, and environmental practices and deter-
Part 1: General Principles
mine the applicability of regulatory limitations prior to use. ISO 1183 Plastics—Methods for Determining the Density of
1.6 This international standard was developed in accor-
Non-cellular Plastics—Part 2: Density Gradient Column
dance with internationally recognized principles on standard- Method
ization established in the Decision on Principles for the ISO 10993 Biological Evaluation of Medical Devices, Parts
Development of International Standards, Guides and Recom- 1-12
mendations issued by the World Trade Organization Technical ISO 13485 Medical Devices—Quality Management
Barriers to Trade (TBT) Committee. Systems—Requirements for Regulatory Purposes
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 [e-mail]. 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 Aug. 1, 2023. Published August 2023. Originally the ASTM website.
approved in 2000. Last previous edition approved in 2017 as F2026 – 17. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2026-23. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2026 − 23
ISO 15309 Implants for Surgery—Differential Scanning 5. Properties
Calorimetry of Poly Ether Ether Ketone (PEEK) Polymers
5.1 The properties listed below shall be considered in
and Compounds for Use in Implantable Medical Devices
selecting material(s) in accordance with the specific end-use
2.3 Other Documents:
requirements.
United States Pharmacopeia, Vol. XXI, or latest edition 5
5.2 The infrared spectrum of these materials is character-
istic of their molecular repeating units. A representative spec-
3. Terminology
trum is listed in Appendix X3. The PEEK polymer shall yield
3.1 Definitions of Terms Specific to This Standard:
an infrared spectrum, which exhibits major bands only at the
3.1.1 fabricated forms, n—those items into which the virgin wavelengths listed for a standard reference spectrum of that
forms may be converted. These include shapes and forms
material.
produced by means of machining, extruding, and compression 5.2.1 The infrared spectrum, as used in this specification, is
molding virgin forms into a subsequent entity (for example,
to identify the specific type of poly aryl ether ketone (PAEK)
fibers, tubes, rods, slabs, sheets, film, or complex shaped parts
present and does not necessarily indicate an acceptable degree
and devices). of material purity.
5.2.2 The presence of additional bands in the sample’s
3.1.2 formulated compound, n—materials, parts, or devices
infrared spectrum compared to that of the reference material
fabricated from virgin forms in such a way as to contain
may indicate a different PAEK or impurities, or both.
intentional or unintentional adjuvant substances.
5.3 The physical and chemical property requirements for the
3.1.3 virgin forms, n—the initially delivered form of the
virgin polymer are listed in Table 1. If additional characteristics
polymer as synthesized from its monomers prior to any
are necessary because of a specific application, the procedures
processing or fabrication into a medical device. The provided
referenced in Section 2 are recommended, or as agreed upon
resin is typically in the form of pellets, granules, or powder and
between the vendor and the purchaser.
is the material from which fibers, tubes, rods, slabs, sheets,
films, or specific parts and devices are fabricated.
5.4 The viscosity requirements will vary depending upon
the grade and test method. The method and requirements shall
4. Classification
be agreed upon between the vendor and the purchaser.
4.1 The PEEK polymer in the scope of this specification is
5.5 The chemical, physical, and mechanical properties of
a pure semicrystalline homopolymer consisting of phenylene
fabricated forms are related to the processes utilized in
rings connected by ether (E) and carbonyl (or ketone, K)
producing the fabricated form (for example, molding,
groups along the polymer chain (see Appendix X1). Its
machining, sterilization, and so forth). Additionally, the prop-
polymeric structure is defined by the repeating unit EEK.
erties necessary for a particular device to perform properly will
vary from one device type to another. Table 2 lists some typical
4.2 Types of PEEK plastics, molding, and extrusion grades
properties of non-sterilized fabricated forms.
are described in Classification System D4000.
Silverstein, R. M., Bassler, G. C., and Morrill, T. C., Spectroscopic Identifica-
tion of Organic Compounds, 5th ed., John Wiley & Sons, New York, NY.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org.
TABLE 1 Required Properties of Virgin Resin
Parameter Method Requirement
A
Glass transition DSC, 20 °K ⁄min, sealed sample, T 125–165
g
B
taken on second reheat, D3418
temperature, T (°C)
g
Melt temperature, DSC, 20 °K ⁄min, sealed sample, T 320–360
m
T (°C) taken as max point on reheat endotherm,
m
D3418
Recrystallization DSC, 20 °K ⁄min, sealed sample, T taken 260–320
c
temperature,T (°C) as max point on cooling exotherm, D3418
c
Viscosity As agreed per 5.4 As
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 17 F2026 − 23
Standard Specification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant
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).(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 and healthsafety, 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.
2. Referenced Documents
2.1 ASTM Standards:
D256 Test Methods for Determining the Izod Pendulum Impact Resistance 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
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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 Nov. 15, 2017Aug. 1, 2023. Published December 2017August 2023. Originally approved in 2000. Last previous edition approved in 20162017
as F2026 – 16.F2026 – 17. DOI: 10.1520/F2026-17.10.1520/F2026-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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
F2026 − 23
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential
Scanning Calorimetry
D4000 Classification System for Specifying Plastic Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2 ISO Standards:
ISO 178 Plastics—Determination of Flexural Properties
ISO 180 Plastics—Determination of Izod Impact Strength
ISO 527 Plastics—Determination of Tensile Properties—Part 1: General Principles
ISO 1183 Plastics—Methods for Determining the Density of Non-cellular Plastics—Part 2: Density Gradient Column Method
ISO 10993 Biological Evaluation of Medical Devices, Parts 1-12
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
ISO 15309 Implants for Surgery—Differential Scanning Calorimetry of Poly Ether Ether Ketone (PEEK) Polymers and
Compounds for Use in Implantable Medical Devices
2.3 Other Documents:
United States Pharmacopeia, Vol. XXI, or latest edition
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 fabricated forms, n—those items into which the virgin forms may be converted. These include shapes and forms produced
by means of machining, extruding, and compression molding virgin forms into a subsequent entity (for example, fibers, tubes, rods,
slabs, sheets, film, or complex shaped parts and devices).
3.1.2 formulated compound, n—materials, parts, or devices fabricated from virgin forms in such a way as to contain intentional
or unintentional adjuvant substances.
3.1.3 virgin forms, n—the initially delivered form of the polymer as synthesized from its monomers prior to any processing or
fabrication into a medical device. The provided resin is typically in the form of pellets, granules, or powder and is the material
from which fibers, tubes, rods, slabs, sheets, films, or specific parts and devices are fabricated.
4. Classification
4.1 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 (see Appendix X1). Its polymeric structure
is defined by the repeating unit EEK.
4.2 Types of PEEK plastics, molding, and extrusion grades are described in Classification System D4000.
5. Properties
5.1 The properties listed below shall be considered in selecting material(s) in accordance with the specific end-use requirements.
5.2 The infrared spectrum of these materials is characteristic of their molecular repeating units. A representative spectrum is listed
in Appendix X3. The PEEK polymer shall yield an infrared spectrum, which exhibits major bands only at the wavelengths listed
for a standard reference spectrum of that material.
5.2.1 The infrared spectrum, as used in this specification, is to identify the specific type of poly aryl ether ketone (PAEK) present
and does not necessarily indicate an acceptable degree of material purity.
5.2.2 The presence of additional bands in the sample’s infrared spectrum compared to that of the reference material may indicate
a different PAEK or impurities, or both.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Silverstein, R. M., Bassler, G. C., and Morrill, T. C., Spectroscopic Identification of Organic Compounds, 5th ed., John Wiley& Wiley & Sons, New York, NY.
F2026 − 23
5.3 The physical and chemical property requirements for the virgin polymer are listed in Table 1. If additional characteristics are
necessary because of a specific application, the procedures referenced in Section 2 are recommended, or as agreed upon between
the vendor and the purchaser.
5.4 The viscosity requirements will vary depending upon the grade and test method. The method and requirements shall be agreed
upon between the vendor and the purchaser.
5.5 The chemical, physical, and mechanical properties of fabricated forms are related to the processes utilized in producing the
fabricated form (for example, molding, machining, sterilization, and so forth). Additionally, the properties necessary for a
particular device to perform properly will vary from one device type to another. Table 2 lists some typical properties of
non-sterilized fabricated forms.
5.6 Test specimens shall be fabricated (machined, injection molded, and so forth) from the virgin polymer, or finished part, in such
a way as to effectively represent the material characteristics of the non-sterilized finished part.
5.6.1 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.
5.7 Tests and test procedures shall be such as to ensure a high level of control and characterization of the virgin polymer as
received from the supplier. The test methods referenced in Section 2 may be appropriate (Test
...