ASTM F2003-00
Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
- Standard No.
- ASTM F2003-00
- Release Date
- 2000
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2003-02
- Latest
- ASTM F2003-02(2022)
- Scope
1.1 It is the intent of this guide to permit an investigator to investigate the oxidative stability of ultra-high molecular weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This guide describes a laboratory test method for accelerated aging of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperatures and, alternatively, at elevated partial pressures of oxygen, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical and mechanical stability.
1.2 Although the accelerated-aging test methods described by this guide will permit an investigator to compare the oxidative stability of UHMWPE, it is recognized that these test methods may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation. However, these accelerated oxidation methods have been successfully used to rank UHMWPE materials for their long-term oxidative stability.
1.3 The accelerated aging test methods specified herein have been validated based on oxidation levels exhibited by certain shelf-aged UHMWPE components packaged in air and sterilized with gamma radiation. The methods have not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, these test methods have not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen.
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.
ASTM F2003-00 Referenced Document
- ASTM D883 Standard Terminology Relating to Plastics
- ASTM F1714 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
- ASTM F1715 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
- ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ISO 14242 Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
- ISO 14243 Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of the patellofemoral joint
- ISO 5834 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method
ASTM F2003-00 history
- 2022 ASTM F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
- 2002 ASTM F2003-02(2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
- 2002 ASTM F2003-02(2008) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
- 2002 ASTM F2003-02 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
- 2000 ASTM F2003-00 Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
