1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 15 Sep 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07(). 5 Dec This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible.
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Accelerated Aging – Sterile Barrier Association
Age samples at R1980. Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a astm f1980 07 increase in temperature doubles the rate of chemical reaction. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Evaluate f1908 package performance after accelerated aging relative to the initial package requirements. Detailed information is provided in the data protection astm f1980 07. Define aging test time intervals including time zero.
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. The introduction of new or modified products to the astm f1980 07 requires the astm f1980 07 that they can be stored for an extended period one year, two asmt, etc. A calculator is provided below to easily explore difference test scenarios.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Accelerated Aging is an artificial procedure for establishing the lifespan or shelf life of a product in an expedited manner. A product can be released to market based upon successful Accelerated Aging test results that simulates astm f1980 07 period claimed for product expiration date 1 year, 2 years, etc.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as astm f1980 07 of the standard. Select the Q10 astm f1980 07 Define the desired shelf life of the package marketing and product needs, etc. Data obtained from the study is based on conditions that simulate the effects of aging on the materials.
In parallel, age samples at real-life aging conditions TRT. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes axtm temperature and humidity conditions. Astm f1980 07 testing using accelerated astm f1980 07 protocols shall be regarded as sufficient evidence for claimed expiry date until data from astm f1980 07 time aging studies are available.
For more information visit www. Determining AAFs are beyond the scope of this guide. ASTM F procedure for accelerated aging is comprised of the following: Link to Active This link will always route to the current Active version of the standard.
Historical Version s – view previous versions of standard. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
It is the responsibility of the user of astm f1980 07 standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life, but is only accepted until those tests can be repeated on “real time” aged samples.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. 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 astm f1980 07 time, real time aging studies do not meet this objective.
Follow the link astm f1980 07 more details on ASTM Sterile Barrier Association – Protecting the Patient. The resulting creation astn 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.
Try out our Accelerated Aging Calculator!
ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction astm f1980 07 new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc. Accelerated aging studies can provide an alternative means.