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| <p> |
| The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure |
| as part of toxicological risk assessment (TRA) of medical device polymers. |
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| <h2> CHRIS modules </h2> |
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| • <a href="/color2"> Color additives RST (v2) </a> |
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| <p> |
| A tool to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components |
| that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether |
| the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or |
| testing to demonstrate acceptable biological risk. |
| </p> |
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| • <a href="/exposure2"> Bulk chemicals (excluding color additives) RST (v2) </a> |
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| <p> |
| This module can be used similarly to the color additive tool, but can be applied to any non-color additive bulk additive or impurity (surface impurities / manufacturing |
| residuals are excluded) that is present in a polymeric device component provided that the user can justify the chemical is a bulk species and that |
| the total amount of the chemical is known, e.g. from a certificate of analysis. |
| </p> |
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| • <a href="/efficiency"> Extraction efficiency RST </a> |
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| <p> |
| This module can be used to estimate the fraction of the total pool or solvent concentration of a bulk chemical that will |
| be extracted under different conditions, thereby providing feedback on “worst-case” device geometries and |
| extraction conditions depending on the endpoint of interest. |
| </p> |
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| <h2> Modules in development </h2> |
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| • <a href="/color3"> Color additives (v3) </a> |
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| <p> |
| An updated version of the color additive module that can address additional polymers using a machine learning method. |
| </p> |
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| • <a href="/exposure3"> Bulk chemicals (excluding color additives) (v3) </a> |
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| <p> |
| An updated version of the bulk chemicals module that can address additional polymers using a machine learning method. |
| </p> |
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| • <a href="/quantity"> Total quantity estimator </a> |
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| <p> |
| This module can be used to leverage the results of device extraction testing (either exhaustive or non-exhaustive) to estimate the total quantity of an extractable present in the device, |
| which can subsequently be used for exposure estimation using the color additives or bulk chemicals modules. |
| </p> |
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