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ISO 10993-16:2017Published

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Évaluation biologique des dispositifs médicaux — Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables

A new edition is under development: ISO/FDIS 10993-16.

Abstract / scope

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Life cycle

Replaces

ISO 10993-16:2010WithdrawnBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesInternational Standard · Published 9 Feb 2010 · ISO/TC 194

Replaced by

ISO/FDIS 10993-16Under developmentBiological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachablesInternational Standard · ISO/TC 194