A VERSATILE METHOD OF VERIFICATION TEST FOR RADIATION STERILIZATION

The international standard (ISO) of radiation sterilization recommends dose setting methods using sublethal verification sterility test at SAL (Sterility Assurance Level) of inverse sample size (n). An acceptance probability of the verification is low for small n. A proposed flexible verification method uses preselected verification probability and independent to SAL of 1/n, required from margin of safety. This will add a rationality for statistical dose setting method.