June 12, 2013
Most medical device manufacturers have defined acceptance criteria when it comes to the resistance of their biological indicators (BIs). The resistance of a BI can be determined by verification of the D-value or by verification of the survival/kill time response characteristics. The...
See BlogMay 3, 2013
Ethylene oxide (EO) validation is conducted as part of a 510(k) or PMA submission. It validates the EO sterilization process as a whole and ensures that the process produces product that meets requirements for a sterility claim. The validation is specific...
See Blog
