Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
1.1.1 This document provides requirements for the development , validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent .
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization , and organizations responsible for sterilizing medical devices .
NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges
the similarities and differences between the two applications.