1 Jan Buy ASTM F R GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES from SAI. chemical structure of the material and how this chemical structure withstands the environmental hazards through time. Reference: ASTM F (, ). Scope of ASTM F ➢Provides information for developing accelerated aging protocols. ➢Information may be used to support shelf life and expiration date.
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Age samples at TAA.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Try out our Accelerated Aging Calculator!
In parallel, age samples at real-life aging conditions TRT. Follow the link for more details on ASTM Data obtained from the study is based on conditions f198 simulate the effects of aging on the materials.
Define package material xstm, seal strength and integrity tests, sample sizes, and acceptance criteria. ASTM F procedure for accelerated aging is comprised of the following: Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life, but is only accepted until those tests can be repeated on “real time” aged samples.
A product can be released to market based upon successful Accelerated Aging test results that simulates the period claimed for product expiration date 1 year, 2 years, etc. Evaluate the package performance after accelerated aging relative to the initial package requirements.
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. Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10C increase in temperature doubles the rate of chemical reaction. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 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.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Accelerated Aging is an artificial procedure for establishing the lifespan or asfm life of a product in an expedited manner. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.