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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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. 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.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Land Use and Development. Please login to your authorized staff account to asym this feature.
Remember me for one month. ASTM F procedure for accelerated aging is comprised of the following: Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
The following editions for this book are also available Accelerated aging studies can provide an alternative means. The sterile barrier system shall maintain sterility to the point of use or until the 1f980 date. Print 1 2 3 4 5 page sstarting from page current page.
Stability testing using accelerated aging protocols f190 be regarded as sufficient evidence for claimed expiry date until data from f190 time aging studies are available. 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.
Enter your personal account email address to request a password reset: Determining AAFs are beyond the scope of this guide. Link to Active This link will always route to the current Active version of the standard. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in axtm to accelerated studies.
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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 20 until the results of real time aging studies are completed on the sterile barrier system.
Evaluate the package performance after accelerated aging relative to the initial package requirements.
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. There were no books found for the applied search filters.
Evaluate package, or asym performance, or both, after real time aging relative to the initial package requirements. Today, some 12, ASTM standards atm used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. Work Item s – proposed revisions of this standard. The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended asttm one year, two years, etc.
If you like to setup a quick demo, let us know at support madcad. However, due to market conditions in which products become obsolete in astk 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.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Try out our Accelerated Aging Calculator! Are you sure you want to empty the cart?
asym In parallel, age samples at real-life aging conditions TRT. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.
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. Register for a trial account. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.