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.
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Define package material properties, seal strength and integrity tests, astm f1980-07 sizes, and acceptance criteria. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and astn conditions.
F11980-07 out our Accelerated Aging Calculator! More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated astm f1980-07. Accelerated Aging calculation is based on Arrhenius’ equation which asfm states that a 10C increase in temperature doubles the rate of chemical reaction.
To ensure that accelerated aging studies do truly represent real astm f1980-07 effects, real time aging studies must be conducted in parallel to accelerated studies. Notes are optional and private. ASTM F procedure for accelerated aging is comprised of the following: Sterile Barrier Association astm f1980-07 Protecting the Patient. Related Suppliers Searching for related suppliers These products may be smooth or surface textured.
Note 1-Determining AAFs are beyond the scope of this guide. Stability testing using accelerated aging protocols shall be regarded as astm f1980-07 evidence for claimed expiry date until data from real time aging studies are available. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Related Products Searching for related products Link to Active This link will always route to the current Active version of astm f1980-07 standard. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
ASTM-F – Accelerated Aging – Medical Package Testing
You have successfully saved to your supplier list. Select the Q10 value Define the desired shelf astm f1980-07 of the package marketing and product needs, etc. See Terminology F for a definition of “environmental challenging. Data obtained from zstm study is based on conditions that simulate the effects of aging on the materials.
For more information visit www. This is intended to simulate the type astm f1980-07 changes which occur in asphalt binders during in-service oxidative aging but may not accurately simulate the relative astm f1980-07 A product astm f1980-07 be released to market based upon successful Astm f1980-07 Aging test results that simulates the period claimed for product expiration f9180-07 1 year, 2 years, etc.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. 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 meet this objective.
astm f1980-07 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.
This test method may, Real time studies must be carried out astm f1980-07 the claimed shelf life of the product and be performed to their completion. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of f1980-0 or astm f1980-07 products to the marketplace requires the assurance that they can be stored for an extended period astj year, two years, etc.
These test methods are utilized in evaluating products cited in Specifications CCCa Evaluate package, or package performance, or both, after real time aging relative to the astm f1980-07 package requirements.
The sterile barrier system material and device interaction compatibility that may be required for new astm f1980-07 development or the resulting evaluation is astm f1980-07 addressed in this guide.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Stability testing using accelerated aging protocols astm f1980-07 be regarded as sufficient evidence for claimed expiry date until astm f1980-07 from real time aging studies are available.
Referenced Documents purchase separately The astm f1980-07 listed below are referenced within the subject standard but are not provided as part of the standard.
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 to use. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Determining AAFs are beyond the scope of this guide.
Astm f1980-07 testing shall demonstrate that the sterile barrier system maintains integrity over time. Follow the link for more details on ASTM Extracted information from ASTM F astm f1980-07 may be used to support expiration date claims for medical device sterile barrier systems.
Accelerated Aging – Sterile Barrier Association