NF EN ISO 10993-9
Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
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.
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.
<p>This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of <i>in vitro</i> degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.</p> <p>This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.</p> <p>This document is not applicable to:</p> <p>a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;</p> <p>NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.</p> <p>b) leachable components which are not degradation products;</p> <p>c) medical devices or components that do not contact the patient's body directly or indirectly.</p>
- Avant-proposiv
- IntroductionVI
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Principes de conception des études de dégradation2
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4.1 Généralités2
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4.2 Considérations préliminaires3
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4.3 Conception d'étude3
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4.4 Caractérisation des produits de dégradation des dispositifs médicaux4
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5 Rapport d'étude4
- Annexe A (normative) Considérations sur le besoin d'études de dégradation5
- Annexe B (informative) Considérations relatives aux études de biodégradation7
- Bibliographie9
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