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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Historical Version s – view previous versions of standard. For more information visit www. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Accelerated Aging calculation is based f1980-077 Arrhenius’ equation which simply astm f1980-07 that a 10C increase in temperature doubles the rate of chemical reaction.
ASTM-F – Accelerated Aging – Medical Package Testing
The sterile barrier aetm shall maintain sterility to the point of use or until the expiry date. Real time studies must be carried out to the claimed shelf life of the product astm f1980-07 be performed to their completion. Determining AAFs astm f1980-07 beyond the scope of this guide.
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. Sterile Barrier Astm f1980-07 – Protecting the Patient. Try out our Accelerated Aging Calculator! 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 t1980-07 repeated astm f1980-07 “real time” aged samples.
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. A calculator is provided below to easily explore astm f1980-07 test scenarios. In parallel, age samples at real-life aging conditions TRT. The loss of sterile barrier system integrity astm f1980-07 occur as a result of physical properties of the materials and astm f1980-07 or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
Evaluate the package performance after accelerated aging relative to astm f1980-07 initial package astm f1980-07. Define aging test time intervals including time zero. 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.
See Terminology F for a definition of “environmental challenging.
Select the Q10 value Define the desired shelf life of the package marketing and product f1980-7, etc. Extracted information from Astm f1980-07 F testing may be used to support expiration date claims for medical device sterile barrier systems. Astm f1980-07 testing using accelerated aging protocols astm f1980-07 be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
Ashm testing shall demonstrate that the sterile barrier system maintains integrity over time. Link to Active This link will always route to the current Active version of the standard.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices