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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There were no books found for the applied search filters. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not atm as part of the standard. Register for a trial account. Enter your account email address to request a password reset: 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.
ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Asgm 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.
Determining AAFs are beyond the scope of this guide.
Define aging test time intervals including time zero. 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.
In parallel, age samples at real-life aging conditions TRT. If you like to setup a quick demo, let us know at support madcad. Link to Active This link will always route to the current Active version of the standard.
FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Accelerated aging studies can provide an alternative means. Historical Version s – view previous versions of standard. The following editions for this book are also available More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
The sterile v1980 system shall maintain sterility to the adtm of use or until the expiry date. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the aatm of regulatory limitations prior to use.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Please login to your authorized staff account to use this feature. Try out our Astk Aging Calculator! Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Evaluate the package performance after accelerated aging relative to the initial package requirements.
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Remember me for one month. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. 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.
Real time studies must be carried out to the claimed shelf 0 of the product and be performed to their completion.
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.
For more information visit www. 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. ASTM F procedure for accelerated aging asym comprised of the following: Print 1 2 3 4 5 page sstarting from page current page.
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. Age samples at TAA.