but in this case as far as I can tell this instrument isn't. did i read wrong?
That will never happen. Mfg stds never specify technical details. They move too slowly. Rather, they specify
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the criteria and methodologies for evaluating things that can go wrong, and let mfg decide best current approach.
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The FDA says "this is the level of rigor we expect you to use. Prove that you did." They don't prescribe specifics.
End of conversation
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