ISO/AWI TS 26420

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

General information

Current stage: 20.00 Effective date: Jan 27, 2026

Originator: ISO

Owner: ISO/TC 194

Type: Technical Specification

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.

Life cycle

NOW

IN_DEVELOPMENT
ISO/AWI TS 26420
20.00 New project registered in TC/SC work programme
Jan 27, 2026