ISO/CD TS 26420

Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1

Scope

This document includes guidance for determining contact duration and relevant biological harms for medical devices where bioaccumulation is expected or contact is intermittent.
This document clarifies 6.4.3.2 Intermittent contact and 6.4.3.3 Bioaccumulation in ISO 10993-1:2025 and includes processes and examples.