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ISO 10993-13:2010

(Main)

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

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

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.

Évaluation biologique des dispositifs médicaux — Partie 13: Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères

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.

General Information

Status
Published
Publication Date
03-Jun-2010
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
ISO/TC 194 - Biological and clinical evaluation of medical devices
Drafting Committee
ISO/TC 194/WG 2 - Degradation aspects related to biological testing
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2024
Completion Date
15-Apr-2024
Ref Project

Relations

Consolidates
ISO/IEC 10026-2:1996 - Information technology — Open Systems Interconnection — Distributed Transaction Processing — Part 2: OSI TP Service
Effective Date
06-Jun-2022
Revises
ISO 10993-13:1998 - Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Effective Date
15-Apr-2008

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INTERNATIONAL ISO
STANDARD 10993-13
Second edition
2010-06-15


Biological evaluation of medical
devices —
Part 13:
Identification and quantification of
degradation products from polymeric
medical devices
Évaluation biologique des dispositifs médicaux —
Partie 13: Identification et quantification de produits de dégradation de
dispositifs médicaux à base de polymères





Reference number
ISO 10993-13:2010(E)
©
ISO 2010

---------------------- Page: 1 ----------------------
ISO 10993-13:2010(E)
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the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.


COPYRIGHT PROTECTED DOCUMENT


©  ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland

ii © ISO 2010 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 10993-13:2010(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Degradation test methods .2
4.1 General procedures.2
4.2 Accelerated degradation test .5
4.3 Real-time degradation test in a simulated environment .6
5 Test procedures.6
5.1 General .6
5.2 Initial material characterization.6
5.3 Accelerated degradation test .6
5.4 Real-time degradation test in a simulated environment .9
6 Test report.10
Annex A (informative) Analytical methods.11
Annex B (informative) Environmental stress cracking (ESC) of polymers.12
Bibliography.14

© ISO 2010 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 10993-13:2010(E)
Foreword
ISO (the International Organization for Standardization) i
...

NORME ISO
INTERNATIONALE 10993-13
Deuxième édition
2010-06-15



Évaluation biologique des dispositifs
médicaux —
Partie 13:
Identification et quantification de produits
de dégradation de dispositifs médicaux à
base de polymères
Biological evaluation of medical devices —
Part 13: Identification and quantification of degradation products from
polymeric medical devices





Numéro de référence
ISO 10993-13:2010(F)
©
ISO 2010

---------------------- Page: 1 ----------------------
ISO 10993-13:2010(F)
PDF – Exonération de responsabilité
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acceptent de fait la responsabilité de ne pas enfreindre les conditions de licence d'Adobe. Le Secrétariat central de l'ISO décline toute
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Adobe est une marque déposée d'Adobe Systems Incorporated.
Les détails relatifs aux produits logiciels utilisés pour la création du présent fichier PDF sont disponibles dans la rubrique General Info
du fichier; les paramètres de création PDF ont été optimisés pour l'impression. Toutes les mesures ont été prises pour garantir
l'exploitation de ce fichier par les comités membres de l'ISO. Dans le cas peu probable où surviendrait un problème d'utilisation,
veuillez en informer le Secrétariat central à l'adresse donnée ci-dessous.


DOCUMENT PROTÉGÉ PAR COPYRIGHT


©  ISO 2010
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous
quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit
de l'ISO à l'adresse ci-après ou du comité membre de l'ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse

ii © ISO 2010 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 10993-13:2010(F)
Sommaire Page
Avant-propos .iv
Introduction.vi
1 Domaine d'application .1
2 Références normatives.1
3 Termes et définitions .2
4 Méthodes d'essai de dégradation.2
4.1 Généralités .2
4.2 Essai de dégradation accélérée.6
4.3 Essai de dégradation en temps réel dans un environnement simulé.6
5 Modes opératoires d'essai .6
5.1 Généralités .6
5.2 Caractérisation du matériau d'origine.7
5.3 Essai de dégradation accélérée.7
5.4 Essai de dégradation en temps réel dans un environnement simulé.9
6 Rapport d'essai.11
Annexe A (informative) Méthodes analytiques .12
Annexe B (informative) Fissuration sous contrainte dans un environnement donné (FCE) des
polymères.13
Biblio
...

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