CHRIS: CHemical RISk calculators

Regulatory Science Tools (RSTs)

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. For a history of updates, please see the changelog.

Below is a list of modules that have been qualified as regulatory science tools (RSTs). For details on RSTs and their potential use in marketing submissions, please consult the RST website.


1. Color additives RST

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.

2. Bulk chemicals (excluding color additives) RST

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.