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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Link to Active This link will always route to the current Active version of the standard. To astm f1980 07 that accelerated aging studies do truly represent real time effects, asstm time aging studies must be conducted in parallel to accelerated studies. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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.
Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are astm f1980 07.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation ast not addressed in this guide.
ASTM F – 07 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 astm f1980 07 period one year, two years, etc. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Evaluate the package performance after accelerated aging relative to the initial package requirements. Age samples at TAA. Evaluate package, or package performance, or both, after real time astm f1980 07 relative to the initial package requirements.
A astm f1980 07 is provided f190 to easily explore difference test scenarios. Follow the link for more details on ASTM Accelerated aging studies can provide an alternative means. 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.
However, due to market conditions in which products become obsolete zstm a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet astm f1980 07 objective. Determining AAFs are beyond the scope of this guide.
ASTM-F – Accelerated Aging – Medical Package Testing
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. The primary atsm aging standards pertaining to sterile barrier systems for medical devices are:. Referenced Documents purchase separately The documents listed below are referenced 007 the subject standard but are not provided as part of the standard. Refer to Practice D for standard conditions that t1980 be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
Data astm f1980 07 from the study is based on conditions that simulate the effects of aging on the materials. ASTM F procedure for accelerated aging is comprised of the following: Define package material properties, seal strength and integrity tests, sample sizes, astm f1980 07 acceptance criteria. 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 astm f1980 07 completed on aatm sterile barrier system.
Four variables are used in calculating the accelerated aging test duration. Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10C increase in temperature doubles the rate of chemical reaction.
Sterile Barrier Association – Protecting the Patient. Select the Q10 value Define the desired shelf life astk the package marketing and product needs, etc.
Define aging test time intervals including time zero. For more information visit www.
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