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ISO 10993-14:2001

(Main)

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

Évaluation biologique des dispositifs médicaux — Partie 14: Identification et quantification des produits de dégradation des céramiques

La présente partie de l'ISO 10993 spécifie deux méthodes permettant d'obtenir des solutions de produits de dégradation à partir des céramiques (dont les verres) dans un but de quantification. Elle donne également des lignes directrices pour l'analyse de ces solutions afin d'identifier les produits de dégradation. Etant donné la nature générale de la présente partie de l'ISO 10993, il convient de prendre en compte en premier lieu les normes spécifiques aux produits qui, lorsqu'elles existent, abordent la formation de produits de dégradation dans des conditions d'utilisation plus pertinentes La présente partie de l'ISO 10993 aborde seulement les produits de dégradation générés par dissociation chimique des céramiques lors d'essais in vitro. Aucune dégradation due à une contrainte mécanique ou une énergie externe ne relève de la présente partie de l'ISO 10993. Alors que l'ISO 6872 et l'ISO 9693 sont des essais de dégradation chimique, elles ne traitent pas de l'analyse des produits de dégradation. Étant donné la gamme des céramiques utilisées dans les dispositifs médicaux et les différentes exigences d'exactitude et de fidélité des résultats, aucune technique d'analyse spécifique n'est identifiée. De plus, la présente partie de l'ISO 10993 ne fait état d'aucune exigence spécifique relative à des niveaux acceptables de produits de dégradation. Bien que ces matériaux soient conçus pour des applications biomédicales, l'activité biologique de ces produits de dégradation ne fait pas l'objet de la présente partie de l'ISO 10993.

General Information

Status
Published
Publication Date
21-Nov-2001
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 3882:1976 - Metallic and other non-organic coatings — Review of methods of measurement of thickness
Effective Date
06-Jun-2022

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INTERNATIONAL ISO
STANDARD 10993-14
First edition
2001-11-15
Biological evaluation of medical devices —
Part 14:
Identification and quantification of
degradation products from ceramics
Évaluation biologique des dispositifs médicaux —
Partie 14: Identification et quantification des produits de dégradation des
céramiques
Reference number
ISO 10993-14:2001(E)
©
ISO 2001

---------------------- Page: 1 ----------------------
ISO 10993-14:2001(E)
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Printed in Switzerland
ii © ISO 2001 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 10993-14:2001(E)
Contents Page
Foreword.iv
Introduction.vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Test procedures.2
4.1 Principle.2
4.2 Testing of dental devices.2
4.3 General testing techniques.3
4.4 Extreme solution test .4
4.5 Simulation solution test .6
5 Analysis of filtrate.9
5.1 General.9
5.2 Choice of chemicals or elements to be analysed.9
5.3 Sensitivity of the analysis method.9
6 Test report .9
Bibliography.11
© ISO 2001 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 10993-14:2001(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of prepar
...

NORME ISO
INTERNATIONALE 10993-14
Première édition
2001-11-15
Évaluation biologique des dispositifs
médicaux —
Partie 14:
Identification et quantification des produits
de dégradation des céramiques
Biological evaluation of medical devices —
Part 14: Identification and quantification of degradation products from
ceramics
Numéro de référence
ISO 10993-14:2001(F)
©
ISO 2001

---------------------- Page: 1 ----------------------
ISO 10993-14:2001(F)
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© ISO 2001
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-aprèsouducomité 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.ch
Web www.iso.ch
Imprimé en Suisse
ii © ISO 2001 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 10993-14:2001(F)
Sommaire Page
Avant-propos.iv
Introduction.vi
1 Domaine d'application.1
2Références normatives .1
3Termesetdéfinitions.2
4 Modes opératoires d’essai.2
4.1 Principe.2
4.2 Essais des dispositifs dentaires .2
4.3 Techniques d’essai générales.3
4.4 Essai de solution extrême .4
4.5 Essai de solution de simulation.6
5 Analyse du filtrat.9
5.1 Généralités .9
5.2 Choix des produits chimiques ou éléments à analyser.9
5.3 Sensibilité de la méthode d’analyse .10
6 Rapport d’essai.10
Bibliographie .11
© ISO 2001 – Tous droits réservés iii

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