SYSTEM 1®
Device Compatibility Testing
Since 1988, the SYSTEM 1Device 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.
E-mail us to request more info.
|
