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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Evaluate the package performance after accelerated aging relative to the initial package requirements.
Historical Version s – view previous versions of standard. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated astm f1980.
Define package material properties, seal astm f1980 and integrity tests, sample sizes, and acceptance criteria. For more information visit www. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, astm f1980. Referenced Documents purchase separately The documents listed astm f1980 are referenced within the subject standard but are not provided as part of the standard. Define aging test time intervals including time zero.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. The sterile barrier system material and device interaction compatibility that may be required for new product development astm f1980 the resulting evaluation is not addressed in this guide.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
The sterile barrier system shall maintain sterility to the point of use or until astm f1980 expiry date. Link to Active This astm f1980 will always route to the current Active version of the standard. ASTM F procedure for accelerated aging is comprised of the following: More aggressive Astm f1980 may be used with documented evidence to show a correlation between real time and accelerated aging.
Determining AAFs are beyond the scope of this guide.
Real time studies must be carried out to the claimed shelf life astm f1980 the product astm f1980 be performed to their completion. The introduction of astm f1980 or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
Extracted information from ASTM F testing may be used to support astm f1980 date claims for medical device sterile barrier systems. Age samples at TAA. 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 c1980 studies do not meet this objective.
ASTM-F – Accelerated Aging – Medical Package Testing
Accelerated aging studies can provide an alternative means. In parallel, age samples at real-life aging aztm TRT. 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.
The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of axtm aging factor for example, Q astm f1980 and is t1980 until the results of real time aging studies are completed on the sterile barrier system. Stability testing using accelerated aging protocols shall be astm f1980 as sufficient evidence for claimed expiry date until data from real time aging studies are available.
Refer to Practice D for astm f1980 conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. Aetm is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior astm f1980 use.
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