Thank you both very much. You have directed me to some useful documents. I believe that all these documents would be classified as guidances. To take my situation a bit further, I am assembling a list of standards for the design, manufacturing, evaluation of an AIMD. AAMI, ANSI, IEC, ISO, MIL, UL, etc. all have standards that would go into this list. However, the only document that I can find that would classify as a standard for clinical evaluation is ISO 14155, which is in fact titled "International Standard." Although the documents to which you have directed me are relevant to the clinical evaluation task, I don't think they qualify as standards in the strict sense. Can you think of any other documents that would fit the "standard" classification?