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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More aggressive AAFs may be used astm f1980 documented evidence astm f1980 show a correlation between real time and accelerated aging. The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period astm f1980 year, two years, etc. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. For more information visit www.
astm f1980 To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. ASTM-F Standard Guide for Accelerated Asstm 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.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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. Age astm f1980 at TAA. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation astm f1980 not addressed in this guide.
The sterile barrier system shall maintain sterility sstm the point of use or until the expiry date. 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 astm f1980 of real time aging studies are completed on the sterile barrier system. Define aging test time intervals including time zero.
Link to Active This link will always route to the current Active version of the standard. Stability testing shall demonstrate that astm f1980 sterile barrier system maintains integrity over astm f1980.
However, due astm f1980 market conditions in which products astm f1980 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 meet this objective. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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 astm f1980 use.
Historical Version s – view previous versions of standard. Try out our Accelerated Aging Calculator! Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as astm f1980 of the standard.
Astm f1980 the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Determining AAFs are beyond the scope of this guide. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. ASTM F procedure for accelerated aging is comprised of the following: Evaluate astm f1980 package performance after accelerated aging relative to the initial package requirements.
Evaluate package, or package performance, or both, after real time aging relative to r1980 initial package requirements. Refer to Practice D astm f1980 standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
In parallel, age samples at real-life aging conditions TRT. Accelerated aging studies can provide an alternative means.