Sterility

Many single use medical devices are terminally sterilized by ethylene oxide or radiation methods such as gamma or e-beam. Regulatory bodies requires that the sterilization process be validated and these validations typically require a sterility testing. 

Before performing a sterility test, it is necessary to verify the suitability of the method. The sterility suitability test is called bacteriostasis and fungistasis testing. It measures whether a device inhibits the growth of bacteria or fungi, which may lead to false negatives during sterility testing.