Cautions in … Accelerated Aging is utilized to establish the shelf life of a product relatively quickly. 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 F1714 (hip wear), Guide F1715 (knee wear), ISO 14242 (hip wear), or ISO 14243 (knee wear), or combination thereof. 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.
4.2 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. These environmental conditions may also be cycled in combination. The ASTM F1980 guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006, and the physical properties of their component packaging materials. Data obtained from the study is based on conditions that simulate the effects of aging on the materials. Link to Active (This link will always route to the current Active version of the standard. 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. Accelerated aging temperature: To be specified, but typically below 60 oC since higher temperature may induce nonlinear changes. ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM International, West Conshohocken, PA, 2016, www.astm.org Back to Top
Shelf life to be simulated (days) Days. ).
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: 1. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered standard. Accelerated Aging Time Calculator ASTM F1980-07. Visit Copyright Clearance Center, Historical Version(s) - view previous versions of standard, More F04.15 Standards F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices, F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices, ICS Number Code 83.080.01 (Plastics in general), UNSPSC Code 13102000(Thermoplastic plastics), ASTM F2003-02(2015), Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air, ASTM International, West Conshohocken, PA, 2015, www.astm.org. This theory is based upon homogeneous materials. Standard References. 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.
Back to Top MDMs push the limits on a daily basis by trying to increase the temperature above the cautioned 60°C to save time. ASTM F2003-02(2015), Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air, ASTM International, West Conshohocken, PA, 2015, www.astm.org.
Accelerated aging is truly a gift by the FDA and EU to allow MDMs to release products to market faster. ANSI/AAMI/ISO 11607-1:2006 2. 1.4 The values stated in SI units are to be regarded as standard. 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. This practice is not intended to simulate any change that may occur in UHMWPE following implantation.
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. °C . The method outlined in this practice permits the evaluation of oxidative stability in a relatively short period of time (for example, weeks). The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Accelerated Aging Time (AAT) Accelerated Aging – oftentimes referred to as Accelerated Shelf-Life Testing – is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. 4.1 This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure.
The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. 2.
Significance and Use 5.1 For inflatable restraints, practices for conducting accelerated aging are designed to determine the aggravated effects on a fabric from exposures to heat, humidity, or ozone, or a combination thereof.
Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard. ASTM F1980 is the standard most people refer to for medical device accelerated aging.
Storage Temperature to be simulated (°C) Typical values are between 20°C and 25°C °C .
ASTM F1980-07 (2011) 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.
Products and Services / Standards & Publications / Standards Products, Active Standard ASTM F2003 | Developed by Subcommittee: F04.15, Permissions to reprint documents can be acquired throughCopyright Clearance Center Its title is Accelerated Aging of Sterile Medical Devices. Related Products
Values above 60°C are not recommended.
This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. 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.
Accelerated aging temperature (°C) Typical values are 50°C , 55°C and 60°C . 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use.