ISO 10993-9:2009Withdrawn

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Évaluation biologique des dispositifs médicaux — Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation

This edition has been replaced by ISO 10993-9:2019.

Abstract / scope

ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.

Life cycle

Replaces

ISO 10993-9:1999WithdrawnBiological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsInternational Standard · Published 4 Mar 1999 · ISO/TC 194

Replaced by

ISO 10993-9:2019PublishedBiological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsInternational Standard · Published 26 Nov 2019 · ISO/TC 194