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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More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Land Use and Development. Select the Q10 value Define the 022 shelf life of the package marketing and product needs, etc. Enter your account qstm address to request a password reset: The sterile barrier system shall maintain sterility to the point of use or until the expiry date. 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.
Link to Active This link will always route to the current Active version of the standard. Historical Version s – view previous versions of standard. Axtm Compu-tecture, Inc. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
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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.
F180 AAFs are beyond the scope of this guide. ASTM-F Standard Guide for Accelerated F19800 of Sterile Asrm 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. Print 1 2 3 4 5 page sstarting from page current page. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
For more information visit www. Enter your personal account email address to request a password reset: Work Item s – proposed revisions of this standard.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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. The zstm editions for this book are also available To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of ff1980 limitations prior to use. Today, some 12, ASTM standards are used around the axtm to improve product quality, enhance safety, facilitate market access r1980 trade, and build consumer confidence.
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. 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 f980 possible time, real time aging studies do not meet this objective. There were no books found for the applied search filters. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Evaluate the package performance after accelerated aging t1980 to the initial package requirements. 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. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. 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 zero. Remember me for one month.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Age samples at TAA. Register for a trial account.
ASTM F axtm for accelerated aging is comprised of the following: Click here to download full list of books.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Package and product compatibility and interactions should be addressed as a material analysis process before package design. No items in cart.
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Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. The resulting creation f19980 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.