ASTM F2026-17

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 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 health 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: Historical
• Publication Date: 14-Nov-2017
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2026 − 17
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, D256 Test Methods for Determining the Izod Pendulum
powder, fabricated forms, and so forth). It provides require- Impact Resistance of Plastics
ments and associated test methods for these thermoplastics D638 Test Method for Tensile Properties of Plastics
when they are to be used in the manufacture of intracorporeal D648 Test Method for Deflection Temperature of Plastics
devices such as surgical implants or components of surgical or Under Flexural Load in the Edgewise Position
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
1.4 The values stated in SI units are to be regarded as D4000 Classification System for Specifying Plastic Materi-
standard. No other units of measurement are included in this als
F748 Practice for Selecting Generic Biological Test Methods
standard.
for Materials and Devices
1.5 When evaluating material in accordance with this
3
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 and health practices and determine the applica- Part 1: General Principles
bility 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 Nov. 15, 2017. Published December 2017. Originally the ASTM website.
3
approved in 2000. Last previous edition approved in 2016 as F2026 – 16. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2026-17. 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
1

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F2026 − 17
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2.3 Other Documents: 5.2 The infrared spectrum of these materials is character-
4
United States Pharmacopeia, Vol. XXI, or latest edition istic of their molecular repeating uni
...

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 − 16 F2026 − 17
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 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 health 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
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
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
3
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
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 April 1, 2016Nov. 15, 2017. Published May 2016December 2017. Originally approved in 2000. Last previous edition approved in 20142016 as
F2026 – 14.F2026 – 16. DOI: 10.1520/F2026-16. 10.1520/F2026-17.
2
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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
1

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F2026 − 17
ISO 1183 Plastics—Methods for Determining the Density of Non-cellular Plastics—Part 2: Density Gradient Column Method
ISO 10993 Biological Eva
...