ASTM F1980-21 "Standard Guidance for Accelerated Aging of Sterile Barrier Systems for Medical Apparatus" provides guidance for the development of accelerated aging protocols for simulating the potential effects of time on the sterile integrity of sterile barrier systems (SBS). This standard emphasizes the importance of accelerated aging studies in verifying the material and integrity of sterile barrier systems, particularly in light of market conditions where products may become obsolete in the short term. The standard guidance details how to determine appropriate accelerated aging factors (AAFs) and emphasizes the need for real-time aging studies to be conducted in parallel with accelerated studies to confirm the results of accelerated testing. In addition, this guide also points out the scope and applications that should be considered when developing accelerated aging protocols, as well as areas not covered, such as new product development and compatibility assessment of material interactions.
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| CCS | ICS |
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