FDA Shelf Life Requirements for EO Surgical gown 510k

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MIREGMGR

Re: FDA Shelf life questions for EO Surgical gown 510k

1) What does the "Baseline" here mean?
2) This is a real time aging study, why should meet the ?Before Accelerated Aging? requirements and ?After Accelerated Aging? requirements?

Your "baseline" data is the properties you measure before anything that might cause those properties to change, including fabrication, sterilization if applicable, aging, etc.

Usually the "before accelerated aging" properties are post-fabrication-and-sterilization.

Because that can be unclear, it's a good idea when using terms to describe the "before" and "after" states for such testing to include a precise definition of each such term.
 
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