Low-dose Irradiation
Allografts should be exposed to a validated terminal sterilization process. Low-dose, low temperature gamma irradiation between 10 and 15 kGy (1.0 to 1.5 Mrads) can provide a sterility assurance level (SAL) of 10-6 without jeopardizing the structural or biomechanical properties of the allograft. An SAL of 10-6 means there is a less than one in one million chance that a single microorganism survived the sterilization process. This is the same sterility level recommended for all other medical implants.