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ASTM F 2565 : 2021

Current
Current

The latest, up-to-date edition.

Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

21-05-2021

1.1This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648.

1.2This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.

1.3This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

1.4The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.

1.5The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: 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.

1.6This 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
4
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2091 : 2015 Standard Specification for Acetabular Prostheses (Withdrawn 2023)
ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis

ASTM F 2003 : 2002 : R2022 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
ASTM F 763 : 2022 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
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 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 E 647 : 2023 : REV A Standard Test Method for Measurement of Fatigue Crack Growth Rates
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 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 D 2765 : 2016 : R2024 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
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 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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