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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Link to Active This link will always route to the current Active version of the standard. 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. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Accelerated aging studies can provide an alternative means. Enter your personal account email address to request a password reset: 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 adtm be stored for an extended period one year, two years, etc. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
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. Please login to your authorized staff account to use this feature.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. 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.
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. Search book title Enter keywords asstm book title search.
Enter your account email address to request a password reset: Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Age samples at TAA.
Evaluate the package performance after accelerated aging relative to the initial package requirements. No items in cart.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard 20 are not provided as part of the standard. For more information visit www.
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. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
The following editions for this book are also available Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
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Define aging test time intervals including time zero. 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.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Register for a trial account. 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.
Package and product compatibility and interactions should be addressed as a material analysis process before package design. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Copyright Compu-tecture, Inc.
Determining AAFs are beyond the scope of this guide. However, due to market conditions in which products become aatm 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. There were no books found for the applied search filters. Historical Version s – view previous versions of standard.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Are you sure you want to empty the cart? Remember me for one month.
Land Use and Development. Work Item s – proposed revisions of this standard.
It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine d1980 applicability of regulatory limitations prior to use.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
If you like to setup a quick demo, let us know at support madcad. Print 1 2 3 4 5 page sstarting from page current page. ASTM F procedure for accelerated aging is comprised of the following: In parallel, age samples at real-life aging conditions TRT.
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