The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period (one year, two years, etc.) without any decrease in performance that may affect safety and efficacy when the products are used.
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.
It is imperative to administer accelerated aging (ASTM F1980) tests to present experimental data in support of performance and shelf-life claims for these products until full-period or “real time” aged samples become available. Extracted information from ASTM F1980 testing may be used to support expiration date claims for medical device sterile barrier systems.
Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
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