ASTM F3336-22
Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging

Standard No.

ASTM F3336-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3336-22

Scope

1.1 It is the intent of this practice to permit an investigator to incorporate lipids found in the synovial environment into polymeric specimens. This can be used as a preconditioning step to evaluate the oxidative stability of ultra-high-molecularweight polyethylene (UHMWPE) materials. This practice describes a laboratory procedure for preconditioning of UHMWPE specimens. 1.2 The preconditioned UHMWPE can be aged at elevated temperature and at elevated oxygen pressure following methods of accelerated aging described in Practice F2003, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical stability. 1.3 The preconditioned UHMWPE can be tested without further aging using a method to evaluate oxidative stability such as oxidation induction time as described in Test Method D3895. 1.4 The methods of this practice may be used on any type of UHMWPE material intended for use in total joint arthroplasty in a synovial joint (for example, conventional, cross-linked, antioxidant stabilized, etc.). See Appendix X1. 1.5 Although the preconditioning method followed by accelerated aging described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method is not known to simulate the degradative mechanisms for an implant during real-time shelf aging or in vivo. The described methods have not been evaluated for mechanical testing under cyclic loading. 1.6 The preconditioning and accelerated aging methods specified herein are intended to rank the resistance to oxidation of materials as a result of the absorption of lipids, which may occur in UHMWPE following implantation, and to determine susceptibility to oxidative changes. The methods have not been evaluated for use in preconditioning of UHMWPE components for subsequent testing of mechanical or wear properties. Procedure A should not be used for preconditioning of UHMWPE components for subsequent testing of mechanical or wear properties. 1.7 The 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. 1.8 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. 1.9 This 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 F3336-22 Referenced Document

• ASTM D3895 Standard Test Method for Oxidative-Induction Time of Polyolefins by Differential Scanning Calorimetry
• ASTM D883 Standard Terminology Relating to Plastics*， 2024-02-01 Update
• ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air*， 2022-11-15 Update
• ASTM F2102 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ISO 5834 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method

ASTM F3336-22 history

• 2022 ASTM F3336-22 Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging