ASTM F2759-19
(Guide)Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
SIGNIFICANCE AND USE
4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders.
4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.
4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model.
4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.
4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.
4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review. (A) For materials terminally sterilized by gamma or e-beam irradiation.
SCOPE
1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.
1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.
1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal 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 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
- 30-Nov-2019
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.11 - Polymeric Materials
Relations
- Effective Date
- 01-Dec-2019
- Effective Date
- 15-Mar-2024
- Effective Date
- 01-Feb-2024
- Effective Date
- 01-Feb-2024
- Effective Date
- 15-Nov-2023
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Sep-2023
- Effective Date
- 01-Feb-2020
- Effective Date
- 01-Jan-2020
- Effective Date
- 01-Oct-2019
- Effective Date
- 01-Aug-2019
- Effective Date
- 15-Apr-2019
- Effective Date
- 01-Feb-2019
- Effective Date
- 01-Dec-2018
- Effective Date
- 01-Nov-2018
Overview
ASTM F2759-19: Standard Guide for Assessment of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices provides essential guidelines for evaluating UHMWPE as a biomaterial in medical devices designed for musculoskeletal joint replacement. This standard aids developers and researchers in conducting comprehensive preclinical assessments-including physical, chemical, mechanical, biocompatibility, and preclinical evaluations-of UHMWPE components in orthopedic and spinal applications. It contributes to improving the safety and effectiveness of devices such as knee, hip, shoulder, and spinal disk replacements.
Key Topics
- Material Scope: Focuses on UHMWPE used in molded or extruded implantable devices, excluding fiber or tape forms.
- Assessment Recommendations: Describes a broad range of test types, including physical property testing, mechanical assessments, chemical analyses, and biocompatibility evaluations.
- Processing Conditions: Addresses the significance of processing methods, terminal sterilization, and packaging on UHMWPE’s performance and stability.
- Clinical Relevance: Encourages comparisons to predicate materials and emphasizes that preclinical testing does not guarantee clinical outcomes in humans.
- Regulatory Guidance: Aligns assessment practices with FDA guidelines such as IDE, PMA, and 510K, and recommends adherence to Good Laboratory Practice (21 CFR 58) where feasible.
- Types of UHMWPE:
- Conventional UHMWPE (compression-molded or ram-extruded)
- Extensively cross-linked UHMWPE (via gamma or e-beam radiation)
- Antioxidant-stabilized UHMWPE (blended/diffused alpha-tocopherol, also known as Vitamin E)
- Testing Parameters: Identifies key properties to assess, such as viscosity number, elongation stress, ash content, tensile and compression strength, impact resistance, thermal stability, wear, and oxidation.
Applications
The guidelines set forth in ASTM F2759-19 support a wide range of medical applications, especially:
- Joint Replacement Devices: Includes components for knee, hip, shoulder, ankle, elbow, finger, toe, and wrist prostheses.
- Spinal Devices: Covers total disc replacement and related spinal implant applications.
- Material Selection and Qualification: Assists manufacturers and researchers in evaluating new UHMWPE formulations, including the incorporation of antioxidants or modified cross-linking processes, to enhance device longevity and biocompatibility.
- Regulatory Submissions: Facilitates the generation of supporting data for regulatory submissions to agencies like the FDA, by promoting recognized test strategies and referencing validated assessment methods.
- Research and Development: Aids in the benchmarking of UHMWPE properties against published data and clinically successful materials, influencing the design and selection of next-generation orthopedic materials.
Related Standards
ASTM F2759-19 references numerous international and U.S. standards to guide specific tests and procedures for UHMWPE used in orthopedic and spinal devices, including:
ASTM Standards:
- D256, D638, D695: Physical and mechanical property testing
- D2765, F648, F732, F2003, F2025: Chemical and wear testing
- F748, F763, F813, F895, F981: Biocompatibility and biological assessment methods
- F2625, F2695, F2977: Processing and formulation of UHMWPE materials
ISO Standards:
- ISO 5834-1/2: Materials for surgical implants-UHMWPE powder and molded forms
- ISO 10993: Biological evaluation of medical devices
- ISO 14242, ISO 14243, ISO 18192: Wear testing for hip, knee, and spinal implants
Regulatory Guidance:
- 21 CFR 58: Good Laboratory Practice (GLP)
- FDA Guidance: Characterization of UHMWPE in orthopedic devices
Adherence to ASTM F2759-19 and referenced standards ensures that orthopedic and spinal devices employing UHMWPE components meet industry expectations for safety, consistency, and clinical performance. By following these guidelines, stakeholders can improve the reliability and acceptance of their device materials throughout the product lifecycle.
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Frequently Asked Questions
ASTM F2759-19 is a guide published by ASTM International. Its full title is "Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices". This standard covers: SIGNIFICANCE AND USE 4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders. 4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component. 4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model. 4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible. 4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices. 4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review. (A) For materials terminally sterilized by gamma or e-beam irradiation. SCOPE 1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms. 1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details. 1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal 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 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.
SIGNIFICANCE AND USE 4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders. 4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component. 4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model. 4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible. 4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices. 4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review. (A) For materials terminally sterilized by gamma or e-beam irradiation. SCOPE 1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms. 1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details. 1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal 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 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.
ASTM F2759-19 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F2759-19 has the following relationships with other standards: It is inter standard links to ASTM F2759-11, ASTM F2625-24, ASTM D2765-16(2024), ASTM D883-24, ASTM E647-23b, ASTM D883-23, ASTM F2214-23, ASTM F749-20, ASTM D883-20, ASTM F2381-19, ASTM D883-19c, ASTM D883-19a, ASTM D883-19, ASTM D883-18a, ASTM D883-18. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F2759-19 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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: F2759 − 19
Standard Guide for
Assessment of the Ultra-High Molecular Weight
Polyethylene (UHMWPE) Used in Orthopedic and Spinal
Devices
This standard is issued under the fixed designation F2759; 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 ASTM Standards:
1.1 This guide covers general guidelines for the physical,
D256 Test Methods for Determining the Izod Pendulum
chemical, biocompatibility, mechanical, and preclinical assess-
Impact Resistance of Plastics
ments of ultra-high molecular weight polyethylene (UHM-
D638 Test Method for Tensile Properties of Plastics
WPE) in implantable orthopedic and spinal devices intended to
D695 Test Method for Compressive Properties of Rigid
replace a musculoskeletal joint. The UHMWPE components
Plastics
may include knee, hip, shoulder, elbow, ankle, total disc
D883 Terminology Relating to Plastics
replacement, toe, finger, and wrist joint implant devices. This
D2765 Test Methods for Determination of Gel Content and
guide does not cover UHMWPE in fiber or tape forms.
Swell Ratio of Crosslinked Ethylene Plastics
1.2 This guide includes a description and rationale of
D4020 Specification for Ultra-High-Molecular-Weight Poly-
assessments for the various UHMWPE types and processing
ethylene Molding and Extrusion Materials
conditions. Assessment testing based on physical, chemical,
E647 Test Method for Measurement of Fatigue Crack
biocompatibility, mechanical, and preclinical analyses are
Growth Rates
briefly described and referenced. The user should refer to
F619 Practice for Extraction of Medical Plastics
specific test methods for additional details.
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.3 This guide does not attempt to define all of the assess-
ethylene Powder and Fabricated Form for Surgical Im-
ment methods associated with UHMWPE components in plants
orthopedic and spinal devices.
F732 Test Method for Wear Testing of Polymeric Materials
Used in Total Joint Prostheses
1.4 The values stated in SI units are to be regarded as
F748 PracticeforSelectingGenericBiologicalTestMethods
standard. No other units of measurement are included in this
for Materials and Devices
standard.
F749 Practice for Evaluating Material Extracts by Intracuta-
1.5 This standard does not purport to address all of the
neous Injection in the Rabbit
safety concerns, if any, associated with its use. It is the
F756 Practice for Assessment of Hemolytic Properties of
responsibility of the user of this standard to establish appro-
Materials
priate safety, health, and environmental practices and deter-
F763 Practice for Short-Term Screening of Implant Materi-
mine the applicability of regulatory limitations prior to use.
als
1.6 This international standard was developed in accor-
F813 Practice for Direct Contact Cell Culture Evaluation of
dance with internationally recognized principles on standard-
Materials for Medical Devices
ization established in the Decision on Principles for the
F895 TestMethodforAgarDiffusionCellCultureScreening
Development of International Standards, Guides and Recom-
for Cytotoxicity
mendations issued by the World Trade Organization Technical
F981 Practice for Assessment of Compatibility of Biomate-
Barriers to Trade (TBT) Committee.
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Insertion into Bone
F1714 Guide for GravimetricWearAssessment of Prosthetic
This guide 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. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2019. Published February 2020. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2009. Last previous edition approved in 2011 as F2759 – 11. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2759-19. the ASTM website.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
F2759 − 19
Hip Designs in Simulator Devices ISO 14243–2 Implants for Surgery—Wear of Total Knee-
F1715 Guide for Wear Assessment of Prosthetic Knee De- Joint Prostheses. Part 2: Methods of Measurement
signs in Simulator Devices (Withdrawn 2006) ISO 14243–3 Implants for Surgery—Wear of Total Knee-
F2003 Practice for Accelerated Aging of Ultra-High Mo- Joint Prostheses. Part 3: Loading and Displacement Pa-
lecular Weight Polyethylene after Gamma Irradiation in rameters for Wear-Testing Machines with Displacement
Air Control and Corresponding Environmental Conditions for
F2025 Practice for Gravimetric Measurement of Polymeric Test
Components for Wear Assessment ISO 18192–1 Implants for Surgery—Wear of Total Interver-
F2102 Guide for Evaluating the Extent of Oxidation in tebral Disc Prostheses. Part 1: Loading and Displacement
Polyethylene Fabricated Forms Intended for Surgical Parameters for Wear Testing and Corresponding Environ-
Implants mental Conditions for Test
F2214 Test Method forIn Situ Determination of Network
2.3 Federal Standards and Guidance Documents:
Parameters of Crosslinked Ultra High Molecular Weight
21 CFR 58 Good Laboratory Practices Regulations
Polyethylene (UHMWPE)
F2381 Test Method for Evaluating Trans-Vinylene Yield in
3. Terminology
Irradiated Ultra-High Molecular Weight Polyethylene
3.1 Definitions—Additional terminology related to ultra-
Fabricated Forms Intended for Surgical Implants by In-
high molecular weight polyethylene (UHMWPE) and plastics
frared Spectroscopy
can be found in Terminology D883 and Specifications D4020
F2423 Guide for Functional, Kinematic, and Wear Assess-
and F648 and referenced publications (1-7).
ment of Total Disc Prostheses
F2625 Test Method for Measurement of Enthalpy of Fusion, 3.2 Definitions of Terms Specific to This Standard:
Percent Crystallinity, and Melting Point of Ultra-High- 3.2.1 fabricated form, n—any bulk shape of UHMWPE
Molecular Weight Polyethylene by Means of Differential fabricated from the virgin polymer powder with or without
Scanning Calorimetry additives or prior irradiation and used during the process of
F2695 Specification for Ultra-High Molecular Weight Poly- fabricating surgical implants before packaging and steriliza-
ethylene Powder Blended With Alpha-Tocopherol (Vita- tion.
min E) and Fabricated Forms for Surgical Implant Appli- 3.2.1.1 Discussion—This form results from the application
cations of heat and pressure to the virgin polymer powder, and the
F2977 Test Method for Small Punch Testing of Polymeric material characteristics of this form are subject to the appli-
Biomaterials Used in Surgical Implants cable requirements of this guide. In present practice, this
includes ram-extruded bars, compression-molded sheets, and
2.2 ISO Standards:
direct-molded shapes that are subsequently trimmed.
ISO 527 Plastics: Determination of Tensile Properties
ISO 3451–1 Plastics: Determination of Ash Part 1: General
4. Significance and Use
Methods
ISO 5834–1 Implants for Surgery—Ultra High Molecular
4.1 This guide aims to provide guidance for a range of
Weight Polyethylene. Part 1: Powder Form
assessments and evaluations to aid in preclinical research and
ISO 5834–2 Implants for Surgery—Ultra High Molecular
device development of various UHMWPE components in
Weight Polyethylene. Part 2: Molded Forms
orthopedic and spinal devices used for the repair of musculo-
ISO 10993 Biological Evaluation of Medical Devices
skeletal disorders.
ISO14242–1 ImplantsforSurgery—WearofTotalHip-Joint
4.2 This guide includes brief descriptions of various
Prostheses. Part 1: Loading and Displacement Parameters
assessments, representative data, processing conditions, and
for Wear-Testing Machines and Corresponding Environ-
intended use or uses, as well as the qualitative and quantitative
mental Conditions for Test
analyses of the UHMWPE powder to a finished product
ISO14242–2 ImplantsforSurgery—WearofTotalHip-Joint
component.
Prostheses. Part 2: Methods of Measurement
4.3 The user is encouraged to use appropriate ASTM
ISO14242–3 ImplantsforSurgery—WearofTotalHip-Joint
International and other standards to conduct the physical,
Prostheses. Part 3: Loading and Displacement Parameters
chemical, mechanical, biocompatibility, and preclinical tests
for Orbital Bearing Type Wear Testing Machines and
on UHMWPE materials, device components, or devices before
Corresponding Environmental Conditions for Test
assessment of an in vivo model.
ISO 14243–1 Implants for Surgery—Wear of Total Knee-
Joint Prostheses. Part 1: Load and Displacement Param-
4.4 Assessments of UHMWPE should be performed in
eters for Wear-Testing Machines with Load Control and
accordance with the provisions of 21 CFR 58 where feasible.
Corresponding Environmental Conditions for Test
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
The last approved version of this historical standard is referenced on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.astm.org. www.access.gpo.gov.
4 6
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., The boldface numbers in parentheses refer to the list of references at the end of
4th Floor, New York, NY 10036, http://www.ansi.org. this standard.
F2759 − 19
4.5 Studies to support investigational device exemption annealing, sterilization, aging, and packaging. Assessment
(IDE), premarket approval (PMA), or 510K submissions parameters should include and be compared to clinically
should conform to appropriate Food and Drug Administration successful UHMWPE materials.
(FDA) guidelines for the development of medical devices.
7. Test Methods
4.6 Assessments with physical, chemical, mechanical,
7.1 Virgin UHMWPE Powder—The tests shown in Table 2
biocompatibility, and preclinical tests on UHMWPE compo-
should be conducted on the UHMWPE types designated in
nents are not necessarily predictive of human results and
Table 1. Alternative tests, such as ones found in ISO 5834–1
therefore should be interpreted cautiously with respect to
and ISO 5834–2, may be considered with documented analysis
potential applicability to human conditions. Referenced UHM-
and rationale.
WPEpublicationscanbefoundintheReferencessectionatthe
end of this guide for further review.
7.2 UHMWPE Mechanical and PhysicalAssessments—Part
1—The tests shown in Table 3 should be conducted on the
5. UHMWPE Fabricated Forms and Conditions
UHMWPE types designated in Table 1. Alternative tests may
5.1 Conventional UHMWPE is manufactured by compres-
be considered with documented analysis and rationale.
sion molding or ram extrusion and has not been intentionally
7.3 Mechanical and Physical Assessment—Part 2—The
cross-linked before terminal sterilization. 7
tests shown in Table 4 should be conducted on the UHMWPE
5.2 Extensively radiation-cross-linked UHMWPE is manu-
types designated in Table 1. Alternative tests may be
factured by compression molding or extrusion and irradiated
considered, such as electron spin resonance (see X1.1), with
with a dosage higher than 40 kGy of gamma or e-beam
documented analysis and rationale.
radiation for improved wear resistance.
7.4 Preclinical Simulation—Functional testing on the fin-
5.3 Antioxidant (Alpha-Tocopherol)—Two stabilizing meth-
ished UHMWPE component that simulates clinical functions
ods for the antioxidant UHMWPE form (Vitamin E-stabilized
and known failure modes should be considered. Testing that
or alpha-tocopherol) are blending or diffusing. The blending
should be considered include creep, accelerated aging, and/or
method has theVitamin E mixed (blended) into the UHMWPE
shelf-life testing, and functional fatigue loading. Practice
powder before consolidation and radiation cross-linking. The
F2003 should be considered for determining relative oxidative
diffusing method has the Vitamin E diffusing into a consoli- stability.
dated UHMWPE form before or after radiation cross-linking.
7.4.1 Wear—See Table 5.
Also, antioxidant UHMWPE could potentially be used without 7.4.2 Functional Device or Material Testing—UHMWPE
any radiation cross-linking.
implant components have experienced known device failure
modes. Examination of known clinical failure modes through
5.4 Thermal Processing—UHMWPE-fabricated forms un-
functional device or material testing, such as fatigue testing of
dergo at least one or more thermal treatments during the
the post in a posterior-stabilized tibial insert or fatigue-
consolidation processes of extrusion or molding, annealing,
impingement testing of the stem neck and polyethylene liner in
cross-linking,oraftercross-linking.Thethermalhistoryshould
a hip implant, should be considered with new UHMWPE
be documented and its effects assessed with mechanical,
processes, materia
...
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: F2759 − 11 F2759 − 19
Standard Guide for
Assessment of the Ultra High Ultra-High Molecular Weight
Polyethylene (UHMWPE) Used in Orthopedic and Spinal
Devices
This standard is issued under the fixed designation F2759; 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 guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments
of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a
musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe,
finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.
1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions.
Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and
referenced. The user should refer to specific test methods for additional details.
1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic
and spinal 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 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 safety, health, and healthenvironmental 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
D695 Test Method for Compressive Properties of Rigid Plastics
D883 Terminology Relating to Plastics
D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
E647 Test Method for Measurement of Fatigue Crack Growth Rates
F619 Practice for Extraction of Medical Plastics
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
This guide 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 15, 2011Dec. 1, 2019. Published May 2011February 2020. Originally approved in 2009. Last previous edition approved in 20092011 as
F2759 – 09.F2759 – 11. DOI: 10.1520/F2759-11.10.1520/F2759-19.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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.
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F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
F2102 Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
F2183 Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
(Withdrawn 2017)
F2214 Test Method forIn Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene
(UHMWPE)
F2381 Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated
Forms Intended for Surgical Implants by Infrared Spectroscopy
F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
F2625 Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular
Weight Polyethylene by Means of Differential Scanning Calorimetry
F2695 Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and
Fabricated Forms for Surgical Implant Applications
F2977 Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
2.2 ISO Standards:
ISO 527 Plastics: Determination of Tensile Properties
ISO 3451–1 Plastics: Determination of Ash Part 1: General Methods
ISO 5834–1 Implants for Surgery—Ultra High Molecular Weight Polyethylene. Part 1: Powder Form
ISO 5834–2 Implants for Surgery—Ultra High Molecular Weight Polyethylene. Part 2: Molded Forms
ISO 11542–2 Plastics—Ultra-High-Molecular-Weight-Polyethylene (PE-UHMWPE) Molding and Extrusion Materials. Part 2:
Preparation of Test Specimens and Determination of Properties
ISO 10993 Biological Evaluation of Medical Devices
ISO 14242–1 Implants for Surgery—Wear of Total Hip-Joint Prostheses. Part 1: Loading and Displacement Parameters for
Wear-Testing Machines and Corresponding Environmental Conditions for Test
ISO 14242–2 Implants for Surgery—Wear of Total Hip-Joint Prostheses. Part 2: Methods of Measurement
ISO 14242–3 Implants for Surgery—Wear of Total Hip-Joint Prostheses. Part 3: Loading and Displacement Parameters for
Orbital Bearing Type Wear Testing Machines and Corresponding Environmental Conditions for Test
ISO 14243–1 Implants for Surgery—Wear of Total Knee-Joint Prostheses. Part 1: Load and Displacement Parameters for
Wear-Testing Machines with Load Control and Corresponding Environmental Conditions for Test
ISO 14243–2 Implants for Surgery—Wear of Total Knee-Joint Prostheses. Part 2: Methods of Measurement
ISO 14243–3 Implants for Surgery—Wear of Total Knee-Joint Prostheses. Part 3: Loading and Displacement Parameters for
Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
ISO 18192–1 Implants for Surgery—Wear of Total Intervertebral Disc Prostheses. Part 1: Loading and Displacement Parameters
for Wear Testing and Corresponding Environmental Conditions for Test
2.3 Federal Standard:Standards and Guidance Documents:
21 CFR 58 Good Laboratory Practices Regulations
3. Terminology
3.1 Definitions—Additional terminology related to ultra high ultra-high molecular weight polyethylene (UHMWPE) and
plastics can be found in Terminology D883 and Specifications D4020 and F648 and referenced publications (1-7).
3.2 Definitions of Terms Specific to This Standard:
3.2.1 fabricated form, n—any bulk shape of UHMWPE fabricated from the virgin polymer powder with or without additives
or prior irradiation and used during the process of fabricating surgical implants before packaging and sterilization.
3.2.1.1 Discussion—
The last approved version of this historical standard is referenced on www.astm.org.
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. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
The boldface numbers in parentheses refer to the list of references at the end of this standard.
F2759 − 19
This form results from the application of heat and pressure to the virgin polymer powder, and the material characteristics of this
form are subject to the applicable requirements of this guide. In present practice, this includes ram-extruded bars, compression-
molded sheets, and direct-molded shapes that are subsequently trimmed.
4. Significance and Use
4.1 This guide aims to provide guidance for a range of various assessments and evaluations to aid in preclinical research and
device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal
disorders.
4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use
or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.
4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical,
mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of
an in vivo model.
4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.
4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should
conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.
4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not
necessarily predictive of human results and therefore should be, therefore, be interpreted cautiously with respect to potential
applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this
guide for further review.
5. UHMWPE Fabricated Forms and Conditions
5.1 Conventional UHMWPE is manufactured by compression molding or ram extrusion and has not been intentionally
cross-linked before terminal sterilization.
5.2 Extensively radiation-cross-linked UHMWPE is manufactured by compression molding or extrusion and irradiated with a
dosage higher than 40 kGy of gamma or e-beam radiation for improved wear resistance.
5.3 Antioxidant (Alpha-Tocopherol)—Two stabilizing methods for the antioxidant UHMWPE form (Vitamin E-stabilized or
alpha-tocopherol) are blending or diffusing. The blending method has the Vitamin E mixed (blended) into the UHMWPE powder
before consolidation and radiation cross-linking. The diffusing method has the Vitamin E diffusing into a consolidated UHMWPE
form before or after radiation cross-linking. Also, antioxidant UHMWPE could potentially be used without any radiation
cross-linking.
5.4 Thermal Processing—UHMWPE-fabricated forms undergo at least one or more thermal treatments during the consolidation
processes of extrusion or molding, annealing, cross-linkingcross-linking, or after cross-linking. The thermal history should be
documented and its effects assessed with mechanical, physical, chemical, and preclinical testing.
5.5 UMHWPE powder is classified as TypesType 1, 2, or 3. These types have different molecular weights and material
properties as defined in Specification F648.
6. UHMWPE Decision Chart (Table 1)
6.1 The assessment chart shown in Table 1 should be performed as indicated on the listed UHMWPE types.
6.2 UMHWPE fabricated form testing should be pursued with samples that are in the final conditions with respect to annealing,
sterilization, aging, and packaging. Assessment parameters should include and be compared to clinically successful UHMWPE
materials.
TABLE 1 UHMWPE Fabricated Forms and Conditions
Extensively
Test Method Group Conventional Cross-Linked Antioxidant
(Irradiation)
Virgin powder (7.1) X X X
Mechanical and physical—Part 1 (7.2) X X X
A
Mechanical and physical—Part 2 (7.3) X X X
A
Preclinical wear simulation (7.4) X X X
Antioxidant assessment (7.5) X
Packaging and sterilization rationale (Section 8) X X X
Biocompatibility (Section 9) X X X
A
For materials terminally sterilized by gamma or e-beam irradiation.
F2759 − 19
7. Test Methods
7.1 Virgin UHMWPE Powder—The tests shown in Table 2 should be conducted on the UHMWPE types designated in Table
1. Alternative tests, such as ones found in ISO 5834–1 and ISO 5834–2),5834–2, may be considered with documented analysis
and rationale.
7.2 UHMWPE Mechanical and Physical Assessments—Part 1—The tests shown in Table 3 should be conducted on the
UHMWPE types designated in Table 1. Alternative tests may be considered with documented analysis and rationale.
7.3 Mechanical and Physical Assessment—Part 2—The tests shown in Table 4 should be conducted on the UHMWPE types
designated in Table 1. Alternative tests may be considered, such as electron spin resonance (see X1.1), with documented analysis
and rationale.
7.4 Preclinical Simulation—Functional testing on the finished UHMWPE component that simulates clinical functions and
known failure modes should be considered. Testing that should be considered include creep, accelerated aging, and/or shelf- life
shelf-life testing, and functional fatigue loading. Practice F2003 should be considered for determining relative oxidative stability.
7.4.1 Wear—See Table 5.
7.4.2 Functional Device or Material Testing—UHMWPE implant components have experienced known device failure modes.
Examination of known clinical failure modes through func
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