Reusable Device Testing
Microtest offers exceptional testing of medical devices manufactured for reuse in clinical settings. Tests include:
• High/low-level disinfection
• Cleaning studies
• Steam/EO/chemical sterilization
Our services are ideal to support initial U.S. FDA Section 510(k) submissions on new products or for use after a relevant change to an existing product or packaging. Examples include endoscopes, orthopedic surgery kits, arthroscopes, and a range of surgical instruments. Our reusable device testing methodologies include sterilization via steam or ethylene oxide (EO), and chemical disinfection.
A new $7.5 million capital investment has included new reusable device testing equipment and facilities. These enable enhancements such as automated washing, gravity/vacuum hospital steam sterilizer cycles, and programmable EO sterilization cycles.
In addition, a new reusables lab — via a partnership with Symmetry Polyvac in Manchester, New Hampshire, U.S.A. — has doubled our reusable device testing capacity. So we can provide quicker throughput and better service to you.
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