ASTM F1980-07 EBOOK DOWNLOAD
15 Sep 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07(). 1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 5 Dec This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible.
|Published (Last):||23 April 2007|
|PDF File Size:||3.35 Mb|
|ePub File Size:||4.72 Mb|
|Price:||Free* [*Free Regsitration Required]|
Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life, but is only accepted until those tests astm f1980-07 be repeated on “real time” aged samples.
Detailed information is provided in the data protection policy.
ASTM-F – Accelerated Aging – Medical Package Testing
The sterile barrier system material and device interaction compatibility that may be required for new product astm f1980-07 or the resulting evaluation is not addressed in this guide. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or astmm products to the marketplace astm f1980-07 the assurance that they can be stored for an extended period one year, two years, etc.
For more information astm f1980-07 www. Sterile Barrier Association – Protecting the Patient. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. To astm f1980-07 that accelerated aging aatm do truly represent real time effects, real time aging studies must be conducted in parallel astm f1980-07 accelerated studies.
Conservative accelerated aging factors AAFs must be used if little is known about the sterile barrier system material being evaluated.
Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine astm f1980-07 applicability of regulatory limitations prior to use.
The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor astm f1980-07 example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system.
Stability testing astm f1980-07 demonstrate that astm f1980-07 sterile barrier system maintains integrity over time. Accelerated aging studies can provide an alternative means. ASTM F procedure for accelerated aging is comprised of the following: 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.
More astm f1980-07 AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not f1908-07 over time.
Define aging test time intervals including time zero. Astm f1980-07 Suppliers Searching for related suppliers See Terminology F for a definition of “environmental challenging.
Astm f1980-07 Aging calculation is based on Arrhenius’ equation which simply states that a 10C increase in temperature doubles the rate of chemical reaction. A calculator is provided below to easily explore difference test scenarios.
When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted astm f1980-07 parallel to accelerated studies.
However, astm f1980-07 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 astm f1980-07 studies do not meet this objective.
Astm f1980-07 Aging is an artificial procedure for establishing the lifespan or shelf life of a product in an asm manner. The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive astm f1980-07 cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
You have successfully saved to your supplier list. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
These test methods are utilized in evaluating products cited in Specifications CCCa Try out our Accelerated Aging Calculator! Real astm f1980-07 studies must be carried out to astm f1980-07 claimed shelf life of the product and be performed to astm f1980-07 completion.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.