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EN ISO 10993-6:2026

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2026)

Edition date: 2026-05-20
In Force
Available languages: English, French
Summary: Dieses Dokument legt Anforderungen für Implantationsprüfverfahren zur vorklinischen Beurteilung lokaler Effekte nach der Implantation von Medizinprodukten oder von Materialien, die zur Verwendung in Medizinprodukten vorgesehen sind, fest. Dieses Dokument ist für die Bewertung lokaler Gewebereaktionen von Medizinprodukte, die für einen Einsatz vorgesehen sind, bei dem die Haut oder Schleimhaut durchbrochen wird, anwendbar. Dieses Dokument ist anwendbar auf Medizinprodukte oder Materialien, die eine Implantationsprüfung erfordern und die fest oder nicht fest (beispielsweise poröse Materialien, Flüssigkeiten, Gels, Pasten, Puder und Partikel) sein können, die resorbierbar, abbaubar oder nicht resorbierbar sein können oder die durch Tissue Engineering hergestellte medizinische Produkte (TEMPs) sein können. Diese Implantationsprüfungen sind nicht dazu vorgesehen, die Leistung des Prüfmusters im Sinne der mechanischen Belastbarkeit oder funktionale Leistung zu bewerten oder zu ermitteln. Dieses Dokument stellt auch keinen Leitfaden zu Verfahren oder zum Studienaufbau dar, um Anforderungen bezüglich systemischer Toxizität, Karzinogenität, Teratogenität oder Mutagenität zu erfüllen. Die Studienaufbauten können jedoch modifiziert werden, um auch andere biologische Effekte zu bewerten.

This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.

Le présent document spécifie les exigences relatives aux méthodes d'essai d'implantation pour l'évaluation préclinique des effets locaux après l'implantation de dispositifs médicaux ou de matériaux destinés à être utilisés dans des dispositifs médicaux. Le présent document s'applique à l'évaluation des réponses tissulaires locales à des dispositifs médicaux destinés à être utilisés en cas de lésion de la peau ou des muqueuses, si nécessaire. Le présent document s'applique aux dispositifs médicaux/matériaux qui nécessitent une évaluation de l'implantation et qui peuvent être solides ou non solides (tels que des matériaux poreux, des liquides, des gels, des pâtes, des poudres et des particules), absorbables, dégradables ou non absorbables, ou qui peuvent être des produits médicaux issus de l’ingénierie tissulaire (TEMPs). Ces essais d'implantation ne sont pas destinés à évaluer ou à déterminer la performance de l'échantillon d'essai en termes de charge mécanique ou de performance fonctionnelle. Le présent document ne fournit pas non plus de recommandations sur les méthodes et la conception des études permettant de satisfaire aux exigences relatives à la toxicité systémique, à la cancérogénicité, à la tératogénicité ou à la mutagénicité. Cependant, les conceptions d’étude peuvent être modifiées afin d'évaluer d'autres effets biologiques.
ICS: 11.100.20-Biological evaluation of medical devices
CTN: CEN/TC 206 - 6187

Otras Relaciones

Acuerdo de Viena ISO 10993-6:2026

Reemplazo Normas

Reemplaza a EN ISO 10993-6:2016

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