ASTM F 2759 : 2019
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
Hardcopy , PDF
English
01-02-2020
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
6
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
Supersedes |
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.
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 D 883 : 2024 : REV A | Standard Terminology Relating to Plastics |
ASTM F 2003 : 2002 : R2022 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air |
ASTM E 647 : 2024 | Standard Test Method for Measurement of Fatigue Crack Growth Rates |
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 E 647 : 2023 : REV B | 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 F 2625 : 2024 | 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 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.