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ASTM F 2003 : 2002 : R2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

Available format(s)

Hardcopy , PDF

Superseded date

21-11-2022

Language(s)

English

Published date

03-07-2015

$108.03
Including GST where applicable

CONTAINED IN VOL. 13.01, 2015 Describes the oxidative stability of UHMWPE materials as a function of processing and sterilization method.

Committee
F 04
DocumentType
Standard Practice
Pages
4
ProductNote
Reconfirmed 2015
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical and mechanical stability.

1.2Although the accelerated-aging method described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation.

1.3The accelerated aging method specified herein has been validated based on oxidation levels exhibited by certain shelf-aged UHMWPE components packaged in air and sterilized with gamma radiation. The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, this practice has not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen. This practice is not intended to simulate any change that may occur in UHMWPE following implantation.

1.4The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered 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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F 2722 : 2021 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
ASTM F 2624 : 2012 : R2020 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
ASTM F 3336 : 2022 Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
ASTM F 2565 : 2021 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis
ASTM F 2582 : 2020 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
ASTM F 2083 : 2021 Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
ASTM F 2759 : 2019 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2977 : 2020 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ASTM F 2759 : 2011 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2582 : 2014 Standard Test Method for Impingement of Acetabular Prostheses
ASTM F 2777 : 2016 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
ASTM F 2624 : 2012 : R2016 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
ASTM F 2565 : 2013 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ASTM F 2977 : 2013 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ASTM F 2722 : 2015 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

ISO 14242-1:2014 Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ASTM F 1714 : 1996 : R2008 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F 1715 : 2000 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices
ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ASTM F 1714 : 1996 : R2002 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM F 1714 : 1996 : R2013 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F 648 : 2014 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ASTM F 1714 : 1996 : R2018 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F 648 : 2021 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ASTM F 1714 : 1996 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ISO 14243-3:2014 Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ISO 14243-1:2009 Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

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