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 .
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Copyright Compu-tecture, Inc. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Search book title Enter keywords for book title search.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. 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.
Work Item s – proposed revisions of this standard. Try out our Accelerated Aging Calculator! If you like to setup a quick demo, let us know at support madcad. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
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Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Land Use and Development. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
Enter your account email address to request a password reset: Enter your personal account email address to request a password reset: The following editions for this book are also available FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES 20 Packages EDITION to PUBLISHER. Age samples at TAA. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Are you sure you want to empty the cart? Historical Version s – view previous versions of standard. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to aastm extremes in temperature and humidity conditions.
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. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Today, some 12, ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.
Evaluate the package performance after accelerated aging relative to the initial package requirements.
For more information visit www. Click here to download full list of books. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Print 1 2 3 4 5 page sstarting from page current page. 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.
ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 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. Please login to your authorized staff account to use this feature.
There were no books found for the applied search filters. 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.
Register for a trial account. Determining AAFs are beyond the scope of this guide. In parallel, age samples at real-life aging conditions TRT.
Accelerated aging studies can provide an alternative means. Remember me for one month. It is the responsibility of the user of this standard to establish appropriate safety f190 health practices and determine the applicability of regulatory limitations prior to use.
However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Referenced Documents asgm separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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. Define aging test time intervals including time zero. ASTM F procedure for accelerated aging is comprised atm the following: