Sterilization Validation testing confirms the appropriate Sterility Assurance Level (SAL), dry time, and thermoprofiling of the medical device. The testing establishes the pertinent sterilization parameters for health care processing 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 the following modalities for sterilization; moist heat (gravity or prevacuum), ethylene oxide (EO), and dry heat.
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.
Applicable Standards
- AAMI TIR12
- AAMI ST79
- AAMI ST77
- ISO 17665
- ISO 17664
- ISO 11135