AAMI ST77 Reusable Device Studies
Microtest offers exceptional testing of medical devices manufactured for reuse in clinical settings. Tests include:
Our AAMI ST77 reusable device studies 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.
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