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.
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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
1
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
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
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
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
1
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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
3
signs in S
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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
1
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
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
1
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.
2
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2759 − 19
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 Hi
...
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