SYSTEM 1® Device Compatibility Testing

Since 1988, the SYSTEM 1 Device Compatibility Testing Program has evaluated material compatibility and sterile efficacy of thousands of reusable medical devices after multiple cycles through the SYSTEM 1® Processor. Compatibility with The STERIS PROCESS™ is endorsed by many leading device manufacturers.

The goal of the device compatibility testing is to provide customers assurance that reusable devices can be safely, repeatedly sterilized by The STERIS PROCESS. This is achieved through testing with manufacturers to evaluate sterilization efficacy and material compatibility after multiple STERIS PROCESS cycles.

The SYSTEM 1 Device Testing Program has three objectives:

  • Determine the specific SYSTEM 1 Container/Tray for device reprocessing.
  • Verify the sterilant use dilution is compatible with the device's materials and processes of construction.
  • Confirm that the medical device can be repeatedly sterilized by the STERIS PROCESS.

Test Protocols

All SYSTEM 1 device compatibility testing is performed in the STERIS Microbiology Laboratory. Sterile Validation Testing is in accordance with Good Laboratory Practices (GLPs) as outlined by U.S. regulatory agencies, and employs a method adopted as a standard test method by the American Society for Testing Materials (ASTM). Established protocols, standard operating procedures, and data recording systems maintain consistency and traceability of all tests that are conducted.

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