Sterilization Validations for Device or Trays
A sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The testing establishes the pertinent sterilization parameters for healthcare reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide healthcare facilities with validated sterilization parameters. Nelson Laboratories 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 Laboratories 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 TIR 12
- ISO 17665
- ISO 17664
- ISO 11135
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|RVS110||Sterilization Validation (Reuse): Steam||Add|
|RVS130||Sterilization Validation (Reuse): Steam Tray Study||Add|
|RVS140||Sterilization Validation (Reuse): Ethylene Oxide||Add|
|RVS150||Sterilization Validation (Reuse): Liquid Chemical||Add|
|RVS170||Sterilization Validation (Reuse): Dry Heat||Add|
|RVS180||Sterilization Validation (Reuse): STERRAD®||Add|
RVS110 - Sterilization Validation (Reuse): Steam
RVS130 - Sterilization Validation (Reuse): Steam Tray Study
RVS140 - Sterilization Validation (Reuse): Ethylene Oxide
RVS150 - Sterilization Validation (Reuse): Liquid Chemical
RVS170 - Sterilization Validation (Reuse): Dry Heat
RVS180 - Sterilization Validation (Reuse): STERRAD®
RVS110: Minimum 3 devices required
RVS130: Minimum 1 tray/kit required
RVS140: Minimum 3 devices required
RVS180: Minimum 3 devices required
Study OutlineSteam sterilization sterility assurance level testing: The testing validates the recommended gravity and/or prevacuum steam sterilization parameters for the medical device. Nelson Laboratories validates individual devices, implants, trays, kits or other reusable devices. Typically, a Sterility Assurance Level (SAL) of 10-6 is validated using the biological indicator overkill method. Depending on the specific device, other testing such as dry time validations or internal temperature mapping may be appropriate. Dry time testing ensures that after the sterilization cycle the packaging and device are not wet. Moisture may compromise the sterile properties of the packaged device. Temperature mapping profiles the temperature inside the containment device and demonstrates the heating properties of the device.
Nelson Laboratories validates individual devices, implants, trays, kits, reusable devices or other devices reprocessed at a healthcare facility.