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ANSI/AAMI/ISO 14937:2009 (R2013)
Sterilization of healthcare products -General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
Association for the Advancement of Medical Instrumentation [aami]