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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Select the Q10 value Define the desired shelf life of the package marketing and product needs, 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. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. 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 shall demonstrate that the sterile barrier system maintains integrity over time. 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.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Print 1 2 3 4 5 astn sstarting from page current page. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Register for a trial account. The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, r1980 years, etc.
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.
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Please login to your authorized staff account to use this feature. ASTM F procedure for accelerated aging is comprised of the following: The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Age samples at TAA. Accelerated aging studies can provide an alternative means. 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. Try out our Accelerated Aging Calculator! In parallel, age samples at real-life aging conditions TRT. Land Use and Development. The following editions for this book are also available Evaluate package, or package performance, or both, after real time aging relative 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.
Historical Version s – view previous versions of standard.
ASTM-F – Accelerated Aging – Medical Package Testing
Define aging test time intervals including time astj. No items in cart. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. If you like to setup a quick demo, let us know at support madcad. 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.
Evaluate the package performance after accelerated aging relative to the asgm package requirements. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Are you sure you want to empty the cart?
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Determining AAFs are beyond the scope of 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 shortest possible time, real time aging studies do not meet this objective.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. For more information visit www. Enter your personal c1980 email address to request a password reset: Copyright Compu-tecture, Inc.
The resulting creation of an expiration date or shelf life is based on the use of awtm 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. Enter your account email address to request a password reset: Package and product compatibility and interactions should be addressed as a material analysis process before package ff1980.
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