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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Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. For more information visit www.
Four variables are used in calculating the accelerated aging test duration. 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. Data obtained from the study is based on conditions that simulate the effects of aging on the materials.
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 shelf life of a product in an expedited manner. Follow the link for more details f190 ASTM Define aging test time intervals including time zero.
Accelerated Aging – Sterile Barrier Association
Sterile Barrier Association – Protecting the Patient. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Age samples at TAA. Evaluate the package performance after accelerated aging relative to the initial package requirements. In parallel, age samples at real-life aging conditions TRT.
Detailed information is provided in the data protection policy. Evaluate awtm, or package performance, or both, after real time 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.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. A calculator is provided below to easily explore difference test scenarios.