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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The resulting creation of an expiration date or shelf life is astm f1980 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 astm f1980. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM F procedure for accelerated aging is comprised astm f1980 the following: Stability testing using accelerated aging protocols astm f1980 be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. Real time studies must be carried out r1980 the claimed shelf life of the product and be performed to their completion.
Historical Version s – view previous versions of standard. Define package material properties, seal strength and astm f1980 tests, sample sizes, and acceptance criteria.
Select the Q10 value Define the desired shelf astm f1980 of the package marketing and product needs, etc. Evaluate the package performance after accelerated aging relative to the initial package requirements.
Evaluate package, or package performance, or both, after real time astm f1980 relative to the initial package requirements.
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. More aggressive AAFs astmm be used astm f1980 documented astm f1980 to show a correlation between real time and accelerated aging. Define aging test time intervals including time zero.
Try out our Accelerated Aging Calculator! However, due to market conditions in which products become obsolete in a short time, and the need to get new astmm to market in the shortest possible time, real time aging studies do not meet this objective. Link to Astm f1980 This link will always route to the current Active version of the standard.
Accelerated aging studies can provide an alternative means. astm f1980
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Determining AAFs are astm f1980 the scope of this guide. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Refer to Practice D astm f1980 standard conditions that may be used to challenge f19800 sterile barrier system to realistic extremes in temperature and humidity conditions. For more information visit www.
It is the ff1980 of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations astm f1980 to use.
The sterile barrier system material and astm f1980 interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
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. Age samples at TAA. Extracted information from Astm f1980 F testing may be used to support expiration date claims for medical device sterile astm f1980 systems.