Exploration of a framework to identify cohort of concern substances in medical device risk assessment.

Abstract

Cohort of concern substances (CoCs) present challenges in medical device toxicological risk assessment. They are excluded from the lifetime threshold of toxicological concern (TTC) per ISO/TS 21726, because their toxic dose is < 1.5 μg/day and they may present a higher cancer risk. Relying solely on structural similarities with known toxicants is inadequate for assessing carcinogenic potency. This study selected chemicals from the Carcinogenic Potency Database (CPDB) to establish a framework for