ASTM F2003-02

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

SIGNIFICANCE AND USE
This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure. Under real-time conditions, such as shelf aging and implantation, oxidative changes to UHMWPE after sterilization using high energy radiation may take months or years to produce changes that may result in deleterious mechanical performance. The method outlined in this practice permits the evaluation of oxidative stability in a relatively short period of time (for example, weeks).
This practice may also be used to oxidize UHMWPE test specimens and joint replacement components prior to characterization of their physical, chemical, and mechanical properties. In particular, this practice may be used for accelerated aging of UHMWPE components prior to evaluation in a hip or knee joint wear simulator as outlined in Guide F 1714 (hip wear), Guide F 1715 (knee wear), ISO 14242 (hip wear), or ISO 14243 (knee wear), or combination thereof.
SCOPE
1.1 It 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.
1.2 Although 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.
1.3 The 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.
1.4 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.

General Information

• Status: Historical
• Publication Date: 09-Dec-2002
• ICS: 83.080.01 - Plastics in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F2003-00 - Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
• Effective Date: 10-Dec-2002
• Replaced By: ASTM F2003-02(2008) - Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
• Effective Date: 01-May-2008
• Referred By: ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2582-20 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2777-23 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2722-21 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2977-20 - Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
• Effective Date: 10-Dec-2002
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Dec-2002
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 10-Dec-2002
• Referred By: ASTM F3336-22 - Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
• Effective Date: 10-Dec-2002

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2003–02
Standard Practice for
Accelerated Aging of Ultra-High Molecular Weight
1
Polyethylene after Gamma Irradiation in Air
This standard is issued under the fixed designation F 2003; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 648 Specification of Ultra-High Molecular-Weight Poly-
3
ethylene Powder and Fabricated Form Surgical Implants
1.1 It is the intent of this practice to permit an investigator
F 1714 Guide for Gravimetric Wear Assessment of Pros-
to evaluate the oxidative stability of UHMWPE materials as a
3
thetic Hip-Designs in Simulator Devices
function of processing and sterilization method. This practice
F 1715 Guide for Gravimetric Wear Assessment of Pros-
describes a laboratory procedure for accelerated aging of
3
thetic Knee-Designs in Simulator Devices
ultra-high molecular weight polyethylene (UHMWPE) speci-
2.2 ISO Standards:
mens and components for total joint prostheses. The UHM-
ISO 5834 Implants for surgery—Ultra-high molecular
WPE is aged at elevated temperature and at elevated oxygen
4
weight polyethylene
pressure, to accelerate oxidation of the material and thereby
ISO 14242 Implants for surgery—Wear of total hip joint
allow for the evaluation of its long-term chemical and me-
4
prostheses
chanical stability.
ISO 14243 Implants for surgery—Wear of total knee joint
1.2 Although the accelerated-aging method described by
4
prostheses
this practice will permit an investigator to compare the
oxidative stability of different UHMWPE materials, it is
3. Terminology
recognized that this method may not precisely simulate the
3.1 Definitions—For definitions of terms in this practice
degradative mechanisms for an implant during real-time shelf
relating to plastics, refer toTerminology D 883. For definitions
aging and implantation.
of terms in this practice relating to UHMWPE, refer to
1.3 The accelerated aging method specified herein has been
Specification F 648 and ISO 5834.
validated based on oxidation levels exhibited by certain shelf-
3.2 Definitions of Terms Specific to This Standard:
aged UHMWPE components packaged in air and sterilized
3.2.1 oxidation, n—the incorporation of oxygen into an-
with gamma radiation. The method has not been shown to be
other molecule (for example, UHMWPE) by means of a
representative of shelf aging when the UHMWPE is packaged
chemical reaction, resulting in the formation of a chemical
in an environment other than air. For example, this practice has
covalent bond.
not been directly correlated with the shelf life of components
3.2.2 oxygen bomb, n—a pressure vessel suitable for pre-
that have been sealed in a low-oxygen package, such as
conditioning of UHMWPE at an elevated temperature and
nitrogen. This practice is not intended to simulate any change
partial pressure of oxygen.
that may occur in UHMWPE following implantation.
1.4 This standard does not purport to address all of the
4. Significance and Use
safety concerns, if any, associated with its use. It is the
4.1 This practice summarizes a method that may be used to
responsibility of the user of this standard to establish appro-
accelerate the oxidation of UHMWPE components using
priate safety and health practices and determine the applica-
elevated temperature and elevated oxygen pressure. Under
bility of regulatory limitations prior to use.
real-time conditions, such as shelf aging and implantation,
2. Referenced Documents oxidative changes to UHMWPE after sterilization using high
energy radiation may take months or years to produce changes
2.1 ASTM Standards:
2
that may result in deleterious mechanical performance. The
D 883 Terminology Relating to Plastics
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3
F04.15 on Material Test Methods. Annual Book of ASTM Standards, Vol 13.01.
4
Current edition approved Dec. 10, 2002. Published February 2003. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
Annual Book of ASTM Standards, Vol 08.01. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2003–02
(that is, within 61°C) throughout the duration of the testing period, or the
method outlined in this practice permits the evaluation of
results may not be reproducible or may be unreliable.
oxidative stability in a relatively short period of time (for
example, weeks).
6. Test Specimens
4.2 This practice may
...