Author: Courtney Lang

June 12, 2013

Biological Indicator Resistance Testing

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...

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May 3, 2013

EO Sterilization Validation: Overkill with Benefits

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...

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