Biocompatibility
New chemical and biological biocomp testing on the way
Overview
The COSMIIC team obtained supplemental mini-grants through the NIH SPARC's HORNET program to update biocompatibility testing for the COSMIIC System. This is a necessary component to making sure that users are fully confident in the materials, processing, and cleaning of this human tissue-contacting device. This effort spans generating a Biological Evaluation Plan, which outlines the plan for how to test the COSMIIC System, completing recommended Biocompatibility Testing, and concluding in a Biological Evaluation Report with Toxicological Risk Assessment. These documents can be used as a baseline for new testing and for consideration into risk analysis.
Biological Evaluation Plan (BEP)
We have prepared a example version of a Biocompatibility Evaluation Plan for the COSMIIC System, available for download through the link below.
📁 Click to download a PDF (8.7MB) containing the example BEP
Note: This document includes materials, construction, cleaning information of the base COSMIIC System components (PM2, PG4, BP2, electrodes, and network cables). Regulatory requirements and information in this document may have been obsoleted since original release of these documents. The recommendations for testing in this document were to a specific use case of the COSMIIC System and should not be taken as advice from COSMIIC nor the creator of the report. For up-to-date technical information on the COSMIIC System, please visit the Docs site through cosmiic.org.
Biocompatibility Testing
Coming soon...
Biological Evaluation Report and Toxicological Risk Assessment (BER+TRA)
Coming soon thereafter...