HIGHPOWER’s test methodology is based on methods outlined in AAMI TIR 12, AAMI TIR 17, ANSI/AAMI ST79 and other sterilization specific national and international standards.

Reusable medical devices require device design control testing of materials, systems and finished devices in order to assure that the device and the materials it is comprised of are compatible with the various sterilization processes listed in the devices labeling.

Repeat Cycling/Limits of Reuse Testing is also sometimes referred to as Functionality, Reusability Testing or Materials Compatibility Testing. All these terms mean basically the same thing with the objective of this testing to look for degradation after repeated exposure in the devices claimed sterilization process/processes. The device or material is typically run through one or more sterilization cycles or sterilization processes and then evaluated for any type of degradation.

Let us validate that your device, and the materials it is comprised of, are compatible with the sterilization processes listed in your devices labeling claim. With every major FDA cleared sterilization process in-house (steam, ETO, hydrogen peroxide, peracetic acid, dry heat and chemical vapor), our scientists and technicians can assist device manufacturers in all of their material compatibility and device limits of reuse testing needs.

HIGHPOWER Labs is ASP factory trained to perform STERRAD® functionality and efficacy validation testing.

Tests:

  • Hydrogen Peroxide Processing
  • E.O. Gas Processing
  • Dry Heat Processing (Convection and Forced Air)
  • Chemical Vapor Processing
  • Liquid Chemical Immersion Processing (Cidex, OPA, Glutaraldehyde etc.)

We’re constantly adding new sterilizers to meet our customer’s expectations. If you don’t see the required sterilization process listed, please contact us at info@highpowervtls.com with your inquiry.