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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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: 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 f19880 package performance after accelerated aging relative to the initial package requirements.
Link to Active This link will always route to the current Active version of the standard. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc.
Define aging test time intervals including time zero. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
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. Try out our Accelerated Aging Calculator! The following editions for this book are also available It is the responsibility of asstm user of this standard to establish appropriate safety and health practices and determine the 0 of regulatory limitations prior to use.
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 – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F procedure for accelerated aging is comprised of the following: Accelerated aging studies can provide an alternative means.
If you like to setup a quick demo, let us know at support madcad. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability awtm 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.
Work Item s – proposed revisions of this standard. Are you sure you want to empty the cart? Real time studies must be carried out to the claimed shelf life of the product and be performed c1980 their completion.
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Copyright Compu-tecture, Inc. Please login to your authorized staff account to use this feature. 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.
Enter your 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 can be stored for an extended period one year, two years, etc. 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.
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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. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.