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ISO 10993-13:2010

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Edition date: 2010-06-04
In Force
Available languages: English, French
Summary:

ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers.

ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.



L'ISO 10993-13:2010 fournit des exigences générales pour la conception des essais dans un environnement simulé permettant d'identifier et de quantifier les produits de dégradation de dispositifs médicaux à base de polymères destinés à un usage médical.

L'ISO 10993-13:2010 décrit deux méthodes d'essai permettant de générer des produits de dégradation, un essai de dégradation accélérée utilisée comme méthode à effet éliminatoire et un essai de dégradation en temps réel dans un environnement simulé. Pour les matériaux destinés à polymériser in situ, le polymère durci ou cuit doit être utilisé pour les essais. Les données obtenues doivent être utilisées lors de l'évaluation biologique du polymère. L'ISO 10993-13:2010 ne prend en considération que les polymères non résorbables. Des modes opératoires similaires, mais auxquels ont été apportées les modifications appropriées, peuvent s'appliquer aux polymères résorbables.

L'ISO 10993-13:2010 ne traite que des produits de dégradation résultant d'une altération chimique du dispositif médical à base de polymères dans son état final. Elle ne s'applique pas à la dégradation consécutive à une contrainte mécanique, à l'usure, à des rayonnements électromagnétiques ou à des facteurs biologiques tels que les enzymes, d'autres protéines et l'activité cellulaire, au cours de la durée d'utilisation prévue.
ICS: 11.100.20-Biological evaluation of medical devices
CTN: ISO/TC 194 - 54508

Standards Cancellations

Anula a ISO 10993-13:1998

Es anulada por

Es anulada por

International Equivalence

Identic UNE-EN ISO 10993-13:2010

Normas Conjuntas

Trabajo conjunto ISO/IEC 10026-2:1996

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