Color Hazard and RISk calculator (CHRIS)

Disclaimer: CHRIS is only addresses risk associated with the presence of color additives. Therefore, a favorable outcome by CHRIS does not imply acceptable biological risk for a finished, sterilized device. Further, a successful CHRIS evaluation does not address local biocompatibility endpoints, and therefore additional testing may be needed despite a positive outcome from CHRIS.

For details on how to use the CHRIS, please read the instructions and Context of Use (COU). Answers to frequently asked questions can be found here.

Color additive

Identity: Amount (mg):
Concentration (mg/cm3):

Impurities

Total impurity concentration (%):

Polymer matrix

Identity:

Device characteristics

Exposed surface area (cm2):
Exposure type: permanent prolonged limited Patient type: adults pediatrics neonates other

Assumptions

Check all statements below that are applicable to your color additive containing component:

The clinical use environment does not cause the polymer matrix to swell or degrade.
Color additive particles/aggregates are much smaller than the smallest component dimension (≤ 50x).
The color additive is homogeneously distributed throughout the polymer.
The total amount of color additive is present in dilute concentrations (≤ 2 m/v %).
Manufacturing processes do not impact the stability of the polymer.

Risk assessment

Click to screen your device: