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ASTM F 2759 : 2019

Current
Current

The latest, up-to-date edition.

Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-01-2020

1.1This 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.

1.2This 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.

1.3This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5This 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.

1.6This 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.

Committee
F 04
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2565 : 2013 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ASTM F 2887 : 2017 Standard Specification for Total Elbow Prostheses

ASTM D 256 : 2010 : R2018 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
ASTM D 883 : 2023 Standard Terminology Relating to Plastics
ASTM E 647 : 1995 Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM F 2003 : 2002 : R2022 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
ASTM D 883 : 2024 Standard Terminology Relating to Plastics
ASTM F 763 : 2022 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
ASTM F 2625 : 2007 Standard 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
ASTM D 256 : 2023 : EDT 1 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
ASTM F 763 : 2004 : R2016 Standard Practice for Short-Term Screening of Implant Materials
ASTM F 2003 : 2002 : R2015 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
ASTM E 647 : 2023 Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM D 883 : 2022 Standard Terminology Relating to Plastics
ASTM D 883 : 2020 : REV B Standard Terminology Relating to Plastics
ASTM E 647 : 2022 : REV A Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM E 647 : 2022 Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM F 756 : 2008 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM D 256 : 2023 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
ASTM E 647 : 2023 : REV A Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM F 2977 : 2013 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ASTM D 638 : 2014 Standard Test Method for Tensile Properties of Plastics
ASTM F 2214 : 2023 Standard Test Method for <emph type="ital"> In Situ</emph> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
ASTM F 648 : 2014 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ASTM E 647 : 2015 : EDT 1 Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM F 981 : 2004 : R2016 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
ASTM F 763 : 1999 Standard Practice for Short-Term Screening of Implant Materials
ASTM D 2765 : 2016 : R2024 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
ASTM F 648 : 2021 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ASTM D 695 : 2015 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM E 647 : 2022 : REV B Standard Test Method for Measurement of Fatigue Crack Growth Rates
ASTM D 2765 : 2016 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
ASTM D 695 : 2023 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM F 2214 : 2016 Standard Test Method for <emph type="bdit">In Situ</emph> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
ASTM F 981 : 2023 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
ASTM D 638 : 2022 Standard Test Method for Tensile Properties of Plastics
ASTM F 2625 : 2010 : R2016 Standard 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

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