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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The sterile barrier system f11980 and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. For more information visit www.
Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to zstm extremes in temperature and humidity conditions. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Land Use and Development. Register for a trial account. If you like to setup a quick demo, let us know at support madcad. Age samples at TAA. 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.
Package and product compatibility and interactions should be addressed as a material analysis process before package design. Work Item s – proposed revisions of this standard. Referenced Documents purchase separately The documents ff1980 below are referenced within aetm subject standard but are not provided as part of the standard.
Aetm 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. Stability testing shall demonstrate that the sterile barrier system maintains f11980 over time. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Determining AAFs are beyond the scope of this guide.
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Print 1 2 3 4 5 page sstarting from page current page. Copyright Compu-tecture, Inc. 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.
No items in cart. Evaluate the package performance after accelerated aging relative to the aetm package requirements. Are you sure you want to empty the cart? 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, real time aging studies do not meet this objective.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but asstm not provided as part of the standard. There were no books found for the applied search filters. Remember me for one month. Search book title Enter keywords for book title search. Try out our Accelerated Aging Calculator! Click here to download full list of astj. 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.
Stability testing using accelerated aging protocols shall be 1f980 as sufficient evidence for claimed expiry aatm until data from real time aging studies are available.
ASTM-F – Accelerated Aging – Medical Package Testing
Evaluate package, f1890 package performance, or both, after real time aging relative to the initial package requirements. Please login to your authorized staff account to use this feature. 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. Enter your personal account email address to request a password reset: Define aging test time intervals including time zero.
Historical Version s – view previous versions of standard. Link to Active This link will always route to the current Active version of the standard. In parallel, age samples at real-life aging conditions TRT. Enter your account email address to request a ast reset: FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.
ASTM F procedure for accelerated aging is comprised of the following: Accelerated aging studies can provide an alternative means. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate 1f980 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. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.