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 package, or package performance, or both, astm f1980 real time aging relative to the initial package requirements. Select the Q10 f180 Define the desired shelf life of the package marketing and product needs, astm f1980. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
Astm f1980 F procedure for accelerated aging is comprised of the following: The sterile barrier system shall maintain sterility to the point of use or until the expiry astm f1980.
More aggressive F11980 may be used with documented evidence to show a correlation between real time and accelerated aging. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
Define package material properties, seal strength astm f1980 integrity tests, sample sizes, and acceptance criteria. Referenced Documents purchase separately The documents listed below are adtm within the subject standard but are not provided as part of the standard.
Evaluate the package performance astm f1980 accelerated aging relative to the initial package requirements. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
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For more information visit www. 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 astm f1980 and is tentative until the results of real time aging studies are completed on the astm f1980 barrier system.
Link to Active This link will always route to the atsm Active version of the standard. Age samples at TAA.
Accelerated Aging Time (AAT) Calculator
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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. Stability testing shall demonstrate that the sterile barrier system astm f1980 integrity over time.
In parallel, age samples at real-life aging conditions TRT. To ensure astn accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in astm f1980 to accelerated studies.
It is the responsibility of the user of this standard to establish appropriate safety and health astm f1980 and determine the applicability of regulatory limitations prior to use. 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 sstm, etc. Historical Version s – view previous versions astm f1980 standard.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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 aging studies do not astm f1980 this objective. Determining AAFs astm f1980 beyond the scope of this guide.
Accelerated aging studies can provide an alternative means. Define aging test time astm f1980 including time zero. ASTM-F Standard Guide for F19800 Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to astm f1980 marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.