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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Enter your account email address to request a password reset: In parallel, age samples at real-life aging conditions TRT. Define aging test time intervals including time zero. 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.
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.
Enter your personal account email address to request a password reset: Register for a trial account. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Land Use and Development.
Atsm 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 asttm the sterile barrier system.
There were no books found for the applied search filters. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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. Determining AAFs are beyond the scope of this guide. It is the responsibility of the user of this standard asstm establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing using accelerated f190 protocols shall be regarded as sufficient evidence for claimed expiry date until data from real sstm aging studies are available.
Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Age samples at TAA. Try out our Accelerated Aging Calculator! Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. For more information visit www. Print 1 2 3 4 5 page sstarting from page current page.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. 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.
Evaluate the package performance after accelerated aging relative to the initial package requirements. If you like to setup a quick demo, let us know at support madcad. Historical Version s – view previous versions of standard.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Work Item s – proposed revisions of this standard. ASTM F procedure for accelerated aging is comprised of the following: It is the responsibility of the user of this standard to establish appropriate zstm and health practices and determine the applicability of regulatory limitations prior to use.
The following editions for this book are also available Copyright Compu-tecture, Inc. Refer to Practice D asfm standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. 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. Are you sure you want to empty the cart? Search book title Enter keywords for book title search. Package and product compatibility and interactions should be addressed as a material analysis process before package design. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Click here to download full list of books. No items in cart.
Link to Active This link will always route to the current Active version of the standard.
Please login to your authorized staff account to use this feature. Select the Q10 value Define the desired shelf life of asm package marketing and product needs, etc. 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.