Of course, Inomed Technology is CE-13485 certified through the BSI. We are equally licensed as a cases manufacturer by the FDA.
Tests and validation of our components
We have conducted a number of quality tests in order to validate our case components, for instance:
- Bio-burden test,
- Sterilisation test,
- Drop test,
- Stress-test (check the capacity of silk-screening to resist to multiple autoclaving),
- Cytotoxicity test,
- Sterilisation test of our PPSU corner protection skis,
- Resistance test to oxidation in an autoclave (304 steel MCH / MDC 304),
- PPSU brackets resistance test through multiple autoclaving,
- Inovis M5x8 resistance test to oxidation in autoclave,
- Bioburden and sterilisation test of our INOdiamond silicone mat,
- Influence of pin-etched brackets in autoclave,
- Phoenix corners sterilisation test,
- Silk-screening resistance test through washing and sterilising with cleaning agents between pH 4 and pH 12.
We have established the following studies :
- Risk analysis,
- Essential requirements checklist,
- Medical devices characteristics "Inotray sterilisation trays and accessories".
The following documents are also available :
- Inomed quality manual,
- InoTray general Instructions for sterilisation,
- InoTray declaration of conformity.
A copy of these reports can be sent upon request.