ASTM F3333-20

Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

SCOPE
1.1 This specification covers chopped carbon-fiber reinforced (CFR) polyetheretherketone (PEEK) polymer in pellets, filaments used in additive manufacturing, or fabricated forms. It provides requirements and associated test methods for these thermoplastic composites 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 chopped CFR-PEEK compounds and fabricated forms only. Materials or forms containing colorants, fillers other than carbon fibers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.  
1.2.1 This standard does not include continuous carbon-fiber reinforced PEEK composites, which are fabricated using a different process than chopped CFR-PEEK.  
1.2.2 This standard can include CFR-PEEK compounds that are fabricated with the use of coupling (sizing) agents. However, when coupling agents are used to improve wetting of the carbon fibers, the biological risk assessments and biocompatibility testing should consider these coupling agents.  
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 CFR-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.  
1.6 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.  
1.7 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: 14-Nov-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• 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 F2026-16 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• Effective Date: 01-Apr-2016
• 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 F2026-14 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• Effective Date: 01-Mar-2014
• Refers: ASTM E1994-09(2013) - Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
• Effective Date: 01-Apr-2013
• Refers: ASTM F2026-12 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• Effective Date: 01-Oct-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 F2026-10 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• Effective Date: 01-Sep-2010
• 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

Overview

ASTM F3333-20 provides a comprehensive specification for chopped carbon fiber reinforced (CFR) polyetheretherketone (PEEK) polymers intended for use in surgical implant applications. Published by ASTM International, this standard covers CFR-PEEK in a variety of forms, including pellets, filaments used in additive manufacturing, and fabricated parts. Its primary focus is on defining material requirements and associated test methods to ensure CFR-PEEK is suitable for the manufacture of intracorporeal devices such as surgical implants and components for surgical or dental devices.

CFR-PEEK is increasingly utilized in the medical sector due to its superior mechanical properties, radiolucency, and biocompatibility. ASTM F3333-20 aims to establish confidence in the performance and safety of these advanced thermoplastic composites, supporting the evolving needs of modern medical device manufacturing.

Key Topics

• Material Scope and Limitations:

  • Applies to chopped carbon fiber reinforced PEEK compounds only.
  • Covers pellets, filaments, and fabricated forms without additional colorants, fillers (other than carbon fiber), or other additives.
  • Does not include materials made with continuous carbon fiber reinforcement or blends containing reclaimed materials.

• Physical and Chemical Properties:

  • Specifies property evaluation methods for density, tensile strength, flexural strength and modulus, elongation, and impact resistance.
  • Encourages the use of internationally referenced test methods (ASTM D638, D790, D792, ISO 527, ISO 178, among others).

• Fabrication and Quality Requirements:

  • Addresses the importance of processing methods (injection molding, extrusion, machining, sterilization).
  • Discusses the use of coupling agents, which enhance fiber wetting and bonding but may affect biocompatibility.
  • Stresses adherence to ISO 13485-certified quality management systems.

• Biocompatibility and Testing:

  • Mandates biological risk assessment per ISO 10993 or ASTM F748.
  • Recommends rigorous physical, chemical, and biological testing prior to device manufacture.

• Inspection and Sampling:

  • Outlines requirements for lot inspection, inclusion evaluation, and sampling based on internationally accepted practices (e.g., ASTM E1994).
  • Recognizes the limitations of visual inspections for opaque materials and suggests nondestructive testing such as X-ray or micro-CT.

Applications

The ASTM F3333-20 standard is vital for manufacturers, designers, and quality assurance professionals in the medical device industry who utilize chopped CFR-PEEK polymers for:

• Surgical Implants: Orthopedic, trauma, and spinal implants benefit from the high strength, durability, and imaging compatibility of CFR-PEEK.
• Dental Devices and Components: Fabricated PEEK forms are used for temporary and permanent dental applications.
• Additive Manufacturing: Filaments produced according to this standard enable 3D printing of customized surgical device components with predictable properties.
• Device Prototyping and Development: Assures consistent quality in early-stage product development and testing.

Adhering to ASTM F3333-20 ensures compliance with regulatory and industry expectations for safety, efficacy, and performance of medical devices using CFR-PEEK.

Related Standards

Several related ASTM and ISO standards underpin the testing and classification requirements of ASTM F3333-20:

• ASTM D638: Test Method for Tensile Properties of Plastics
• ASTM D790: Test Methods for Flexural Properties of Plastics
• ASTM D792 / D1505: Test Methods for Density of Plastics
• ASTM D256: Test Methods for Impact Resistance of Plastics
• ASTM F2026: Specification for PEEK Polymers for Surgical Implant Applications
• ASTM F748: Practice for Selecting Biological Test Methods
• ISO 527, ISO 178, ISO 180, ISO 1183-1: Corresponding international test methods for plastics
• ISO 10993: Biological Evaluation of Medical Devices
• ISO 13485: Medical Device Quality Management Systems

Summary

ASTM F3333-20 sets a robust foundation for the use of chopped CFR-PEEK polymers in surgical implant applications, helping ensure material reliability, patient safety, and regulatory compliance throughout the device lifecycle. By adhering to this standard and its related test methods, manufacturers can demonstrate their commitment to high-quality, innovative medical devices.

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: F3333 −20
Standard Specification for
Chopped Carbon Fiber Reinforced (CFR)
Polyetheretherketone (PEEK) Polymers for Surgical Implant
Applications
This standard is issued under the fixed designation F3333; 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 responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This specification covers chopped carbon-fiber rein-
mine the applicability of regulatory limitations prior to use.
forced (CFR) polyetheretherketone (PEEK) polymer in pellets,
filaments used in additive manufacturing, or fabricated forms. 1.7 This international standard was developed in accor-
It provides requirements and associated test methods for these dance with internationally recognized principles on standard-
thermoplastic composites when they are to be used in the
ization established in the Decision on Principles for the
manufacture of intracorporeal devices such as surgical im-
Development of International Standards, Guides and Recom-
plants or components of surgical or dental devices.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.2 The properties included in this specification are those
applicable for chopped CFR-PEEK compounds and fabricated
2. Referenced Documents
forms only. Materials or forms containing colorants, fillers
other than carbon fibers, processing aids, or other additives, as
2.1 ASTM Standards:
well as polymer blends which contain PEEK, or reclaimed
D256 Test Methods for Determining the Izod Pendulum
materials, are not covered by this specification.
Impact Resistance of Plastics
1.2.1 This standard does not include continuous carbon-
D638 Test Method for Tensile Properties of Plastics
fiber reinforced PEEK composites, which are fabricated using
D648 Test Method for Deflection Temperature of Plastics
a different process than chopped CFR-PEEK.
Under Flexural Load in the Edgewise Position
1.2.2 ThisstandardcanincludeCFR-PEEKcompoundsthat
D695 Test Method for Compressive Properties of Rigid
are fabricated with the use of coupling (sizing) agents.
Plastics
However,whencouplingagentsareusedtoimprovewettingof
D790 Test Methods for Flexural Properties of Unreinforced
the carbon fibers, the biological risk assessments and biocom-
and Reinforced Plastics and Electrical Insulating Materi-
patibility testing should consider these coupling agents.
als
1.3 This specification is designed to recommend physical,
D792 Test 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 CFR-PEEK
D1505 Test Method for Density of Plastics by the Density-
polymers for use in medical implant devices.
Gradient Technique
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
standard.
E1994 Practice for Use of Process Oriented AOQL and
LTPD Sampling Plans
1.5 When evaluating material in accordance with this
specification, hazardous materials, operations, and equipment F748 PracticeforSelectingGenericBiologicalTestMethods
may be involved. for Materials and Devices
F2026 Specification for Polyetheretherketone (PEEK) Poly-
1.6 This standard does not purport to address all of the
mers for Surgical Implant Applications
safety concerns, if any, associated with its use. It is the
This specification is under the jurisdiction of ASTM Committee F04 on
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 [e-mail]. For Annual Book of ASTM
Current edition approved Nov. 15, 2020. Published November 2020. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3333-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3333 − 20
2.2 ISO Standards: 4.2 The structure of the chopped carbon fiber is character-
ISO 178 Plastics—Determination of Flexural Properties ized by its route of manufacture (for example,
ISO 180 Plastics—Determination of Izod Impact Strength polyacrylonitrile- (PAN-) or Pitch-based), as well as by the
ISO 527 Plastics—Determination of Tensile Properties— median length and diameter of the fibers. The use of sizing
Part 1: General Principles agents is permissible provided the resulting CFR-PEEK grade
ISO 1183-1 Plastics—Methods for Determining the Density satisfies the biocompatibility requirements of the application
of Non-Cellular Plastics—Part 1: Immersion Method, (see 7.2).
Liquid Pycnometer Method and Titration Method
4.3 The structure of the CFR-PEEK compound is charac-
ISO 10993 Biological Evaluation of Medical Devices, Parts
terized by its volume fraction of fibers.
1–12
4.4 Types of PEEK plastics, molding, and extrusion grades
ISO 13485 Medical Devices—Quality Management
are described in Classification D4000.
Systems—Requirements for Regulatory Purposes
5. Properties
3. Terminology
5.1 The properties listed below shall be considered in
3.1 Definitions of Terms Specific to This Standard:
selecting material(s) in accordance with the specific end-use
3.1.1 compound, n—material, part, or device fabricated
requirements.
from a virgin form in such a way as to contain intentional or
unintentional adjuvant substances. 5.2 The infrared spectrum of the medical-grade PEEK
polymer used in the manufacture of these materials is charac-
3.1.2 fabricated forms, n—those items into which the virgin
teristic of their molecular repeating units. A representative
forms may be converted. These include shapes and forms
spectrum is listed inAppendix X3 of Specification F2026. The
produced by means of machining, extruding, and compression
PEEK polymer, specified in Specification F2026, shall yield an
molding virgin forms into a subsequent entity (for example,
infrared spectrum which exhibits major bands only at the
fibers, tubes, rods, slabs, sheets, film, or complex shaped parts
wavelengths listed for a standard reference spectrum of that
and devices).
material.
3.1.3 virgin form, n—the initially delivered form of the
5.3 Thephysicalandchemicalpropertyrequirementsforthe
polymer as synthesized from its monomers prior to any
virgin polymer are listed in Table 1 of Specification F2026.If
processing or fabrication into a medical device. The provided
additional characteristics are necessary because of a specific
resinistypicallyintheformofpellets,granules,orpowderand
application, the procedures referenced in Section 2 of Specifi-
is the material from which fibers, tubes, rods, slabs, sheets,
cationF2026arerecommended,orasagreeduponbetweenthe
films, or specific parts and devices are fabricated.
vendor and the purchaser.
4. Classification
5.4 The viscosity requirements will vary, depending upon
the grade and test method. The method and requirements shall
4.1 The CFR-PEEK polymer in the scope of this specifica-
be agreed upon between the vendor and the purchaser.
tion is combination of a pure semicrystalline homopolymer
consisting of phenylene rings connected by ether (E) and
5.5 The chemical, physical, and mechanical properties of
carbonyl (or ketone, K) groups along the polymer chain (see
fabricated forms are related to the processes utilized in
Appendix X1), specified by Specification F2026, and by
producing the fabricated form (for example, molding,
chopped carbon fibers (see below). The structure of the PEEK
machining, steri
...