ASTM F2759-11
(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
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.
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.
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.
Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.
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.
Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and should be, therefore, 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.
TABLE 1 UHMWPE Fabricated Forms and Conditions
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 and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Buy Standard
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: F2759 − 11
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 Impact Resistance of Plastics
D638 Test Method for Tensile Properties of Plastics
1.1 This guide covers general guidelines for the physical,
D695 Test Method for Compressive Properties of Rigid
chemical, biocompatibility, mechanical, and preclinical assess-
Plastics
ments of ultra-high molecular weight polyethylene (UHM-
D883 Terminology Relating to Plastics
WPE) in implantable orthopedic and spinal devices intended to
D2765 Test Methods for Determination of Gel Content and
replace a musculoskeletal joint. The UHMWPE components
Swell Ratio of Crosslinked Ethylene Plastics
may include knee, hip, shoulder, elbow, ankle, total disc
replacement, toe, finger, and wrist joint implant devices. This D4020 Specification for Ultra-High-Molecular-Weight Poly-
guide does not cover UHMWPE in fiber or tape forms. ethylene Molding and Extrusion Materials
E647 Test Method for Measurement of Fatigue Crack
1.2 This guide includes a description and rationale of
Growth Rates
assessments for the various UHMWPE types and processing
F619 Practice for Extraction of Medical Plastics
conditions. Assessment testing based on physical, chemical,
F648 Specification for Ultra-High-Molecular-Weight Poly-
biocompatibility, mechanical, and preclinical analyses are
ethylene Powder and Fabricated Form for Surgical Im-
briefly described and referenced. The user should refer to
plants
specific test methods for additional details.
F732 Test Method for Wear Testing of Polymeric Materials
1.3 This guide does not attempt to define all of the assess-
Used in Total Joint Prostheses
ment methods associated with UHMWPE components in
F748 PracticeforSelectingGenericBiologicalTestMethods
orthopedic and spinal devices.
for Materials and Devices
1.4 The values stated in SI units are to be regarded as
F749 Practice for Evaluating Material Extracts by Intracuta-
standard. No other units of measurement are included in this
neous Injection in the Rabbit
standard.
F756 Practice for Assessment of Hemolytic Properties of
1.5 This standard does not purport to address all of the
Materials
safety concerns, if any, associated with its use. It is the
F763 Practice for Short-Term Screening of Implant Materi-
responsibility of the user of this standard to establish appro-
als
priate safety and health practices and determine the applica-
F813 Practice for Direct Contact Cell Culture Evaluation of
bility of regulatory limitations prior to use.
Materials for Medical Devices
F895 TestMethodforAgarDiffusionCellCultureScreening
2. Referenced Documents
for Cytotoxicity
2
2.1 ASTM Standards:
F981 Practice for Assessment of Compatibility of Biomate-
D256 Test Methods for Determining the Izod Pendulum
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1 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
Hip Designs in Simulator Devices
F04.11 on Polymeric Materials.
F1715 Guide for Wear Assessment of Prosthetic Knee De-
Current edition approved April 15, 2011. Published May 2011. Originally
3
signs in Simulator Devices (Withdrawn 2006)
approved in 2009. Last previous edition approved in 2009 as F2759 – 09. DOI:
10.1520/F2759-11.
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
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2759 − 11
F2003 Practice for Accelerated Aging of Ultra-High Mo- Joint Prostheses. Part 2: Methods of Measurement
lecular Weight Polyethylene after Gamma Irradiation in ISO 14243–3 Implants for Surgery—Wear of Total Knee-
Air Joint Prostheses. Part 3: Loading and Displacement Pa-
F2025 Practice for Gravimetric Measurement of Polymeric rameters for Wear-Testing Machines with Displacement
Components for Wear Assessment Control and Corresponding Environmental Conditions for
F2102 Guide for Evaluating the Exte
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2759–09 Designation:F2759–11
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
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.
1.4Units—The1.4 The values givenstated in SI units are to be regarded as the 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 and health practices and determine the applicability of regulatory
limitations prior to use.
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 D1621Test Method for Compressive Properties of Rigid Cellular 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 E132Test Method for
Poisson’s Ratio at
Room Temperature
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
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
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 Feb. 1, 2009. Published February 2009. DOI: 10.1520/F2759-09.
Current edition approved April 15, 2011. Published May 2011. Originally approved in 2009. Last previous edition approved in 2009 as F2759 – 09. DOI:
10.1520/F2759-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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, PA19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2759–11
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and 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
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gam
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.