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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Define aging test time intervals including time zero. Age samples at TAA.
Try out our Accelerated Aging Calculator! 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 f19880, real time aging studies do not meet this objective.
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ASTM-F – Accelerated Aging – Medical Package Testing
Land Use and Development. ASTM F procedure for accelerated aging is comprised of the following: Accelerated aging studies can provide an alternative means. Evaluate the package performance after accelerated aging relative to the initial package requirements.
Enter your account email address to request a password reset: 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. Astk to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. The following editions for this book are also available Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. 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.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Are you sure you want to empty the cart? Package and product compatibility and interactions should be addressed as a material analysis process before package design. No items in cart. 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.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.
Print 1 2 3 4 5 page sstarting from page current page. In parallel, age samples at real-life aging conditions TRT. 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. Select the Q10 value Define the desired shelf life wstm the package marketing and product needs, etc.
There were no books found f198 the applied search filters. 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. 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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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Please login to your authorized staff account to use this feature. Link to Active This link will always route to the current Active version of the standard. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. 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. 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. 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. Copyright Compu-tecture, Inc. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Work Item s – proposed revisions of this standard. Historical Version s – view previous versions of standard. If you like to setup a quick demo, let us know at support madcad. Enter your personal 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.