ISO/CD TS 26177

Biological evaluation of medical devices – Guidance on risk estimation and evaluation in the application of ISO 10993-1

Scope

Clause 6.9 of ISO/FDIS 10993-1:2025 notes that biological risk estimation is an input to determine biological safety and requires that, for each biologically hazardous situation, the manufacturer shall estimate the associated biological risk(s), taking the level of uncertainty inherent in the risk analysis into account. The biological evaluation process established by ISO 10993-1 is itself a risk management process, aligned with the overall principles of ISO 14971.
This document will provide guidance on the conduct of biological risk estimation of medical devices, within the framework established by the ISO 10993 Series of Standards.