This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible. The ASTM F guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of. Designation: F – Standard Guide for. Accelerated Aging of Sterile Medical Device Packages1 This standard is issued under the fixed designation F .
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Print 1 2 3 4 5 page sstarting from page current page. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
Age samples at TAA. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Define aging test time intervals including time zero. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Evaluate the package performance after accelerated aging relative to the initial package requirements. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
ASTM F procedure for accelerated aging is comprised of the following: Package and product compatibility and interactions should be addressed as a material analysis process before package 0. Remember me for one month.
However, due to market conditions in which products become obsolete in a short time, and the need to get new aetm to market in the shortest possible time, real time aging studies do not meet this objective. Today, some 12, ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and g1980, and build consumer confidence.
R1980 Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Enter your account email address to request a password reset: 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.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
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Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Try out our Accelerated Aging Calculator!
In parallel, age samples at real-life aging conditions TRT. Work Item s – proposed revisions of this standard. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Land Use and Development. Register for a trial account. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
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For more information visit www. 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.
ASTM-F – Accelerated Aging – Medical Package Testing
Accelerated aging studies can provide an alternative means. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. Determining AAFs are beyond the scope of this guide. Search book title Enter keywords for book title search. Are you sure you want to empty the cart? Click here to download full list of books.
Enter your personal account email address to request a password reset: The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system.