Abstract / scope
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
ISO 10993-11:2017Published
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Évaluation biologique des dispositifs médicaux — Partie 11: Essais de toxicité systémique
A new edition is under development: ISO/DIS 10993-11.2.