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I will be outsourcing a cleaning validation study as well as a disinfection validation study for our medical device. AAMI TIR12 and TIR30 both say to use at least three replicates and that three is relatively standard.
From TIR30 7.3.2 -
NOTE—A minimum of three replicates and one concurrent positive control and one concurrent negative control is relatively standard in validation studies.
Why is three called out when it isn’t statistically significant? Wouldn’t we need a lot more considering this is attribute data?
From TIR30 7.3.2 -
NOTE—A minimum of three replicates and one concurrent positive control and one concurrent negative control is relatively standard in validation studies.
Why is three called out when it isn’t statistically significant? Wouldn’t we need a lot more considering this is attribute data?