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ISO 10993-16:2010Withdrawn

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

This edition has been replaced by ISO 10993-16:2017.

Abstract / scope

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Life cycle

Replaces

ISO 10993-16:1997WithdrawnBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesInternational Standard · Published 28 Aug 1997 · ISO/TC 194

Replaced by

ISO 10993-16:2017PublishedBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesInternational Standard · Published 16 May 2017 · ISO/TC 194