It is important to understand what a sampling plan entails to ensure the proper numbers of specimens are tested. If you do not test the right quantity of specimens per area, this could lead to a denial of your 510k submission. The previously suggested quantity of 32 may no longer be the correct number to test, unless determined by the sampling plan. A sampling plan uses lot size, among other factors, to determine the appropriate amount of specimens to test per area. Recently, FDA has been placing a greater focus on a manufacturer’s sampling plan to determine the amounts of specimens to test when performing this barrier testing. The standard helps clinical users in determining the type of protective product most appropriate to a particular situation. ANSI/AAMI PB70 is a classification standard based on the liquid barrier performance of protective apparel and drapes used in healthcare facilities.
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