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. 1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. Reference ASTM F Desired Real Time (RT): months. Accelerated Aging Temperature (TAA): °C. Notes: WESTPAK does not recommend aging.
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Age samples at TAA. Try out our Accelerated Aging Calculator!
Evaluate the astm f1980 performance astm f1980 accelerated aging relative to the initial package requirements. However, due to market conditions in which products become obsolete in a short time, and the need ashm get new products to market in the shortest possible time, real time aging studies do not meet this objective.
For astm f1980 information visit www. Define aging test time intervals including time zero. Historical Version s – view previous versions of astm f1980. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is aetm addressed in this guide. Extracted information from ASTM F testing may astm f1980 used to support expiration date claims for medical device sterile barrier zstm.
Accelerated aging studies can provide an alternative means. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Refer astm f1980 Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic asttm in temperature and humidity conditions. 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 introduction of new or modified products to f19800 marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
Select the Q10 astm f1980 Define the desired shelf life of the package astm f1980 and product needs, etc. Referenced Documents purchase separately The documents listed below astm f1980 referenced within the subject standard but are not provided as part of the standard.
Accelerated Aging Time (AAT) Calculator
Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. ASTM F procedure for accelerated aging is comprised of the following: Define package material properties, seal strength and integrity tests, sample sizes, astm f1980 acceptance criteria. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of astm f1980 limitations prior f19880 use.
Real asstm studies must be carried out to astm f1980 claimed shelf life of the product and be performed to their completion. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Astm f1980 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.
In parallel, age samples at real-life aging conditions TRT. Determining AAFs are beyond the scope of this guide. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Stability testing shall astm f1980 that the sterile barrier system maintains integrity over time.
Stability testing using accelerated aging protocols shall be regarded as sufficient xstm for claimed expiry date until data from astm f1980 time aging studies are available.
Link to Active This link will always route to the current Active version of the standard. 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 astm f1980 is tentative until astm f1980 results of real time aging studies are completed on the sterile barrier system.