A Sterilization Validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The testing establishes the pertinent sterilization parameters for health care reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. Nelson Labs can validate using steam (gravity or prevacuum), ethylene oxide (EO), STERRAD® or dry heat.
ANSI/ASMI ST79, ANSI/AAMI ST77, and AAMI TIR12 are guidelines for testing reusable medical devices. Nelson Labs has the equipment and qualified personnel to help guide you through the process. Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations.
- AAMI TIR12
- ISO 17665
- ISO 17664
- ISO 11135