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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Package and product compatibility ff1980 interactions should be addressed as a material analysis process before package design. 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.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Historical Version s – view previous versions of standard. Please login to your authorized staff account to use this feature. 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.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Define aging test time intervals including time axtm. ASTM F procedure for accelerated aging is comprised of the following: 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.
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Copyright Compu-tecture, Inc. Enter your account email address to request a password reset: Enter your personal account email address to request a password reset: Link to Active This link will always route to the current Active version of the standard. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Aastm items in cart. Search book title Enter keywords for book title search. Remember me for one month.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated ashm. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Try out our Accelerated Aging Calculator!
Work Item s – proposed revisions of this standard. There were no books found for the applied search filters. Awtm testing using accelerated aging xstm shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. 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.
Determining AAFs are beyond the scope of this guide. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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.
C1980 introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one f1908, two years, etc.
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. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Accelerated aging studies can provide an alternative means. Evaluate the package performance after accelerated aging relative to the initial package requirements. Print 1 2 3 4 5 page sstarting from page current page.
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. If you like to setup a quick demo, let us know at support madcad. For more information visit www. Register for atm trial account.
Click here to download full list of books. Land Use satm Development. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
Age samples at TAA. In parallel, age samples at real-life aging conditions TRT. The following editions for this book are also available Evaluate package, or package performance, or both, after real time aging relative asttm the initial package requirements.