SAL is a quantitative measure representing the probability of a single viable microorganism surviving on an item after sterilization. A commonly required SAL for medical devices is [latex]10^{-6}[/latex], meaning a one-in-a-million chance of a non-sterile unit. This probabilistic approach acknowledges that absolute sterility cannot be proven, only inferred statistically from プロセス検証. Sterilization cycles are proven with IQ and OQ validation of the equipment, followed by performance testing with biological indicators.

















