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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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. Determining AAFs are beyond the scope of this guide. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. The following editions for this book are also available 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, f11980 time aging studies do not meet this objective.
In parallel, age samples at real-life aging conditions TRT. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages F190 to PUBLISHER. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.
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. Register for a trial account.
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. Remember me for one month.
No items in cart. Print 1 2 3 4 5 page sstarting from page current page. Package and product compatibility and interactions should be addressed as a aztm analysis process before package design. Enter your personal account email address to request a astmm reset: Try out our Accelerated Aging Calculator! Age samples at TAA. Enter your account email address to request a password reset: Accelerated aging studies can provide an alternative means. 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.
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Copyright Compu-tecture, Inc. To xstm that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Define aging test time intervals including time zero. Please login to your authorized staff account to use this feature. Historical Version s – view previous versions of standard.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. ASTM F procedure for accelerated aging is comprised of the following: More aggressive AAFs may be used with documented evidence to f980 a correlation between real time and accelerated aging. 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.
Are you sure you want to empty the cart? 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.
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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. Land Use and Development.
Click here to download 1f980 list of books. 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. Evaluate the package performance after accelerated aging relative to the initial package requirements.
Link to Active This link will always route to ast current Active version of the standard.
ASTM-F – Accelerated Aging – Medical Package Testing
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.
If you like to setup a quick demo, let f11980 know at support madcad. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. There were no books found for the applied search 20. Search book title Enter keywords for book title search.
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Work Item s – proposed revisions of this standard.