Reusable Medical Device Testing

For reusable medical devices, there is increasing scrutiny on the validation of cleaning, disinfection, and sterilization of these devices.  iuvo brings decades of experience to help validate Instructions for Use for our medical device partners to ensure patient safety.

Our services include validation of cleaning, disinfection, and sterilization studies for instruments, and sterilization/penetration and packaging studies for containers. Repetitive exposures in steam, ethylene oxide, Sterrad, and chemical disinfectants can also be provided to permit assessment of functionality and biocompatibility. We are experts in working with prototype devices to help identify problem areas for our clients.

Our full service laboratory can perform all of the microbiological, analytical, and toxicological analyses needed to support this program.

To contact our specialists or learn more about our services, please contact us, and we’d be happy to help you with your application.

References:  AAMI TIRs 12 and 30; ANSI/AAMI ST58, ST77, ST79, ST15883

Tests

Manual Cleaning Validation

Liquid Chemical, Hydrogen Peroxide Gas (Sterrad)

Hospital Steam Sterilization

Hospital EO Sterilization

Disinfection – High Level, Intermediate Level, and Low Level

Automatic Cleaning Validation