For radiation sterilization, what is considered conforming product with respect to delivery of the minimum sterilization dose? For example, is 24.9 kGy conforming to a 25 kGy minimum sterilization dose? Logically, it seems that a 24.9 kGy dose does not incorporate any additional potential impact to patient safety. However, where is the cut-off point?

Answers to these questions will be provided through a mathematical assessment including reverse calculating the corresponding sterilization dose that would still result in a rounded SAL value of 10^-6.0 and 10^-6, depending on whether the SAL must be rounded to one tenth of the exponent, or to a whole number exponent. The rationales and formulas will be discussed along with showing examples and different options for rounding. If an industry-wide rationale can be established to easily assess product that is slightly underdosed, it could result in significant cost and time savings when these events occur.