Approved Work Item
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
Reference number
ISO/AWI TS 26420
Edition 1
© ISO 2026
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 194
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. ICS
  5. ISO/AWI TS 26420