The ISO 11737 - Sterilization of Medical Devices Package provides the requirements to estimate and determine the population of viable microorganisms on a product and to test the sterility of a product that has been treated with a sterilizing agent. The determination of bioburden can be used to validate the sterilization process, monitor the manufacturing processes and assess the overall environmental monitoring programme. This package includes ISO 11737-1:2006
, ISO 11737-1/Cor1:2007
and ISO 11737-2:2009
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