| Classification |
ISO 11140-1 Part 1 Type 4 (Multi-Variable Indicator) |
| Compliance |
CE Marked, UDI Numbered, Patented Design |
| Application |
For use in every pack, peel-pouch, or tray processed in low-temperature VHP, H2O2, and Plasma sterilizers. |
| Monitored Parameters |
Indicates exposure to two or more critical parameters of the VHP/H2O2/Plasma process. |
| Color Change |
Clear, accurate change from Red or orange (Unprocessed) to Yellow (Successfully Processed – Reference Color). |
| Substrate Material |
Tyvek® (Ensures maximum penetration of the sterilant) |
| Interpretation |
Easy to read and interpret: the indicator color changes to the reference color after a successful sterilization cycle. |
| Safety |
Non-Toxic, Single-Use Only. |
| Shelf Life |
3 Years from Date of Manufacture. |
| Storage |
Store in its original packaging between 0∘C and 40∘C and max RH of 70%. Do not expose to direct sunlight or moisture. |
| Traceability |
LOT number and expiration date available on the product label. |
