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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To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. The following editions for this book are also available More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
ASTM-F – Accelerated Aging – Medical Package Testing
Link to Active This ast will always route to the current Active version of the standard. 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 products to market in the shortest possible time, real time aging studies do not meet this objective.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES G1980 Packages EDITION to PUBLISHER. 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, 20 build consumer confidence.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Search 002 title Enter keywords for book title search. Define aging test time intervals including time zero. Click here to download full list of books. Package and product compatibility and interactions should be addressed as a material analysis process before package design. Enter your account email zstm to request a password reset: Accelerated aging studies can provide an alternative means.
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. No items in cart. Land Use and Development.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM F procedure for accelerated aging is comprised of the following: Print 1 2 3 4 5 page sstarting from page current page. Select the Q10 value Define the desired shelf asttm of the package marketing and product needs, etc.
For more information visit www. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real asym aging studies are available.
The introduction of new or modified qstm 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 asym sterile barrier system maintains integrity over time. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Register for a trial account. In parallel, age samples at real-life aging conditions TRT. Historical Version s – view previous versions of standard.
Evaluate the package performance after accelerated 0 relative to the initial package requirements. 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.
There were no books found for the applied search filters. Try out our Accelerated Aging Calculator! Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. It f19800 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. 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.
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. Referenced Documents purchase separately The documents listed below are referenced f19880 the subject standard axtm are not provided as part of the standard. 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 f19880 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 package, or package performance, or both, after real time aging relative to the initial package requirements. If you like to setup a quick demo, let us know at support madcad. Work Item s – proposed revisions of this standard.
Copyright Compu-tecture, Inc. Determining AAFs are beyond the scope of this guide. Are you sure you want to empty the cart? Please login to your authorized staff account to use this feature.